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Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528641
Recruitment Status : Completed
First Posted : August 27, 2020
Results First Posted : February 8, 2022
Last Update Posted : February 8, 2022
Sponsor:
Collaborator:
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Information provided by (Responsible Party):
ReiThera Srl

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition COVID-19
Intervention Biological: GRAd-COV2
Enrollment 98
Recruitment Details  
Pre-assignment Details a total of 180 subjects were screened and 98 subjects were enrolled in the study. seven out of 98 enrolled subjects were not administered vaccine because of withdrawal by subjects (3 subjects) and because the protocol allowed Screening period 21 days passed (4 subjects). a total of 91 subjects were administered vaccine.
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Period Title: Overall Study
Started 15 15 15 16 15 15
Completed 15 15 15 15 15 14
Not Completed 0 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             1
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose Total
Hide Arm/Group Description

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 15 16 15 15 91
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
15
 100.0%
15
 100.0%
0
   0.0%
0
   0.0%
0
   0.0%
45
  49.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
16
 100.0%
15
 100.0%
15
 100.0%
46
  50.5%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
33.9  (9.1) 37.0  (10.2) 36.2  (11.1) 69.5  (4.6) 70.8  (5.6) 70.0  (3.5) 53.1  (18.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
Female
7
  46.7%
5
  33.3%
6
  40.0%
5
  31.3%
5
  33.3%
5
  33.3%
33
  36.3%
Male
8
  53.3%
10
  66.7%
9
  60.0%
11
  68.8%
10
  66.7%
10
  66.7%
58
  63.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
Hispanic or Latino 0 1 0 0 0 0 1
Not Hispanic or Latino 15 14 15 16 15 15 90
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
15 15 15 16 15 15 91
Demographic - weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
73.9  (12.172) 69.7  (14.91) 70.9  (13.49) 73.61  (12.874) 70.37  (10.181) 70.9  (10.54) 71.59  (12.224)
Demographic - Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
173.3  (9.82) 171.9  (10.93) 173.8  (10.21) 169.0  (9.01) 168.1  (11.30) 169.7  (9.47) 170.9  (10.12)
Demographic - BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 15 participants 15 participants 15 participants 16 participants 15 participants 15 participants 91 participants
24.514  (2.5747) 23.367  (3.0412) 23.332  (2.7751) 24.767  (3.0552) 24.574  (2.5569) 25.035  (2.2006) 24.514  (2.5747)
1.Primary Outcome
Title Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination
Hide Description Participants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.
Time Frame 7 days following the vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site pain
10
  66.7%
12
  80.0%
10
  66.7%
2
  12.5%
1
   6.7%
4
  26.7%
Injection site erythema
1
   6.7%
2
  13.3%
2
  13.3%
0
   0.0%
0
   0.0%
1
   6.7%
Injection site swelling
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
   6.7%
Injection site Haematoma
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
2.Primary Outcome
Title Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Hide Description Participants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.
Time Frame 7 days following the vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Headache
5
  33.3%
6
  40.0%
10
  66.7%
6
  37.5%
3
  20.0%
2
  13.3%
Fatigue
8
  53.3%
7
  46.7%
10
  66.7%
7
  43.8%
2
  13.3%
4
  26.7%
Pyrexia
3
  20.0%
4
  26.7%
11
  73.3%
4
  25.0%
4
  26.7%
4
  26.7%
Myalgia
1
   6.7%
5
  33.3%
4
  26.7%
5
  31.3%
1
   6.7%
5
  33.3%
Chills
1
   6.7%
1
   6.7%
6
  40.0%
4
  25.0%
4
  26.7%
6
  40.0%
Nausea
2
  13.3%
2
  13.3%
3
  20.0%
1
   6.3%
3
  20.0%
2
  13.3%
Neutropeonia
1
   6.7%
1
   6.7%
2
  13.3%
1
   6.3%
1
   6.7%
2
  13.3%
Abdominal Pain
1
   6.7%
4
  26.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Diarrhoea
1
   6.7%
3
  20.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
Arthralgia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
Back Pain
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
Cough
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
Faeces Soft
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
Hot flush
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Hyperkalaemia
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
Muscle injury
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
Muscle strain
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
Tooth fracture
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
Dyspnoea
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
Oropharyngeal pain
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ecchymosis
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Tooth abscess
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
0
   0.0%
Chalazion
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
Lymphadenopathy
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title Occurrence of Unsolicited AE 28 Days Following the Vaccination
Hide Description Occurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as "Any AE" occurring 28 days following the vaccination.
Time Frame 28 days following the vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
week 1 - any AE : Mild
9
  60.0%
9
  60.0%
13
  86.7%
9
  56.3%
6
  40.0%
7
  46.7%
week 1 - any AE : Moderate
3
  20.0%
5
  33.3%
6
  40.0%
1
   6.3%
2
  13.3%
2
  13.3%
week 1 - any AE : Severe
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.3%
0
   0.0%
1
   6.7%
week 2 - any AE: mild
5
  33.3%
5
  33.3%
0
   0.0%
5
  31.3%
1
   6.7%
0
   0.0%
week 2 - any AE: moderate
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
week 2 - any AE: severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
week 3 - Any AE: mild
4
  26.7%
3
  20.0%
0
   0.0%
3
  18.8%
1
   6.7%
0
   0.0%
week 3 - any AE: moderate
0
   0.0%
1
   6.7%
2
  13.3%
1
   6.3%
1
   6.7%
0
   0.0%
week 3 - any AE: severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
week 4 - any AE: mild
1
   6.7%
2
  13.3%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
week 4 - any AE: moderate
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
week 4 - any AE: severe
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Occurrence of Serious AE 24 Weeks Following the Vaccination
Hide Description Occurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)
Time Frame 24 weeks following the vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
Any treatment-emergent SAE related to study drug
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Any treatment-emergent SAE
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Change in Leucocytes From Baseline
Hide Description [Not Specified]
Time Frame baseline, Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 leucocytes /L
week 1 -0.033  (1.285) -0.199  (1.3799) -0.265  (0.5758) -0.159  (0.7563) -0.019  (0.4475) 0.055  (0.6884)
week 2 0.218  (1.354) 0.091  (1.2248) -0.099  (0.6808) 0.158  (0.9098) 0.329  (0.7771) 0.190  (0.6531)
week 4 -0.230  (1.2881) 0.472  (1.2324) -0.286  (0.6787) -0.261  (1.0477) 0.186  (1.0368) 0.186  (1.1456)
week 8 0.154  (0.8825) 0.094  (1.2006) -0.029  (1.0882) -0.013  (0.8416) 0.080  (0.5862) -0.087  (0.6728)
week 12 -0.045  (1.0228) 0.409  (1.7620) 0.133  (1.1654) -0.060  (0.9897) 0.357  (0.8966) -0.175  (0.7302)
week 24 -0.695  (1.199) -0.125  (1.0887) -0.263  (0.8854) -0.310  (1.0615) 0.196  (0.7996) 0.199  (0.8817)
6.Primary Outcome
Title Change in Basophils From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 basophils/L
week 1 -0.002  (0.0094) -0.002  (0.0147) -0.010  (0.0169) -0.001  (0.0141) -0.009  (0.0113) -0.001  (0.0162)
week 2 0.001  (0.0122) 0.007  (0.0129) -0.002  (0.0142) 0.004  (0.011) 0.003  (0.0272) 0.004  (0.0124)
week 4 -0.004  (0.0118) 0.0  (0.0120) -0.003  (0.150) 0.001  (0.054) -0.003  (0.0129) 0.004  (0.0199)
week 8 -0.001  (0.0122) 0.001  (0.0133) -0.001  (0.0119) -0.002  (0.0164) -0.005  (0.0092) 0.003  (0.0116)
week 12 0.002  (0.0142) 0.003  (0.0159) 0.0  (0.0108) 0.0  (0.0121) 0.0  (0.0156) 0.002  (0.0142)
week 24 -0.004  (0.0135) 0.004  (0.0112) -0.001  (0.0146) -0.003  (0.0168) -0.004  (0.0140) -0.001  (0.0141)
7.Primary Outcome
Title Change in Eosinophils From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 eosinophils /L
week 1 0.009  (0.0478) -0.017  (0.0649) -0.007  (0.0555) 0.031  (0.0483) 0.009  (0.0674) 0.006  (0.0467)
week 2 0.014  (0.0370) 0.029  (0.0644) 0.024  (0.0697) 0.046  (0.0574) 0.037  (0.0743) 0.021  (0.0439)
week 4 -0.013  (0.0873) -0.003  (0.0603) -0.003  (0.0471) -0.008  (0.0680) 0.001  (0.0442) 0.027  (0.0870)
week 8 -0.023  (0.0716) -0.002  (0.1202) -0.033  (0.0979) 0.010  (0.0732) 0.006  (0.0617) 0.021  (0.0935)
week 12 -0.004  (0.0840) -0.017  (0.077) -0.013  (0.1085) -0.001  (0.0804) 0.007  (0.0707) 0.02  (0.0728)
week 24 -0.051  (0.0907) -0.013  (0.0807) 0.008  (0.1239) 0.012  (0.0914) 0.015  (0.0635) 0.018  (0.0477)
8.Primary Outcome
Title Change in Neutrophils From Baseline
Hide Description Change from baseline was calculated as the value at each week minus the value at the baseline.
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 Neutrophils /L
week 1 -0.241  (1.1183) -0.105  (1.3346) -0.296  (0.5781) -0.391  (0.7397) -0.147  (0.3939) -0.092  (0.5560)
week 2 -0.115  (1.1387) -0.254  (1.0089) -0.313  (0.4109) -0.014  (0.8032) -0.015  (0.5966) -0.044  (0.4523)
week 4 -0.273  (1.3001) -0.417  (1.0814) -0.273  (0.4670) -0.208  (1.0731) 0.116  (0.8245) 0.011  (1.0820)
week 8 -0.131  (0.8082) 0.008  (1.1261) 0.097  (0.9320) 0.054  (0.7545) -0.025  (0.4139) -0.148  (0.5358)
week 12 -0.159  (0.8592) 0.458  (1.8931) 0.153  (1.0128) 0.027  (0.9118) 0.165  (0.6483) -0.180  (0.6024)
week 24 -0.376  (1.1492) -0.141  (0.8632) -0.151  (0.6475) -0.378  (0.9802) 0.073  (0.6629) 0.147  (0.7146)
9.Primary Outcome
Title Change in Monocytes From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 Monocytes /L
week 1 -0.0040  (0.0733) -0.0227  (0.11218) -0.0353  (0.0689) -0.0525  (0.0668) 0.0100  (0.0860) -0.0307  (0.0694)
week 2 0.0733  (0.1011) 0.0427  (0.1353) 0.0227  (0.1109) 0.0144  (0.0999) 0.0520  (0.0844) 0.0280  (0.0820)
week 4 -0.0220  (0.0668) -0.0327  (0.1142) -0.0287  (0.0666) -0.0556  (0.0909) 0.0400  (0.1110) -0.0193  (0.0656)
week 8 0.0073  (0.0612) 0.0113  (0.1336) -0.0380  (0.0927) -0.0431  (0.0624) 0.0253  (0.0801) -0.0227  (0.0849)
week 12 -0.0004  (0.0797) 0.0007  (0.1331) -0.0240  (0.0662) -0.0475  (0.0772) 0.0453  (0.0856) -0.0387  (0.0605)
week 24 -0.0427  (0.0707) -0.0107  (0.1163) -0.0233  (0.1271) -0.0227  (0.0960) 0.0493  (0.1127) -0.0021  (0.0567)
10.Primary Outcome
Title Change in Lymphocytes From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 Lymphocytes /L
week 1 0.209  (0.5808) -0.060  (0.4455) 0.077  (0.2050) 0.179  (0.2565) 0.115  (0.2064) 0.179  (0.2516)
week 2 0.247  (0.3868) 0.257  (0.3913) 0.169  (0.4038) 0.109  (0.2490) 0.249  (0.2813) 0.184  (0.3094)
week 4 0.077  (0.4069) -0.023  (0.3568) 0.013  (0.2528) 0.010  (0.3045) 0.03  (0.2146) 0.103  (0.1823)
week 8 -0.012  (0.3490) 0.063  (0.3991) -0.058  (0.2627) -0.039  (0.2856) 0.077  (0.2252) 0.062  (0.2502)
week 12 0.115  (0.4083) -0.045  (0.3655) 0.015  (0.2884) -0.046  (0.3200) 0.135  (0.2941) 0.031  (0.2214)
week 24 -0.219  (0.3293) 0.027  (0.5038) -0.097  (0.2514) 0.072  (0.2427) 0.064  (0.2607) 0.049  (0.3324)
11.Primary Outcome
Title Change in Erythrocytes From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^12 Erythrocytes /L
week 1 -0.091  (0.1603) -0.067  (0.2342) -0.037  (0.1574) -0.0158  (0.2014) -0.066  (0.2763) -0.074  (0.1644)
week 2 0.001  (0.01757) -0.093  (0.220) -0.037  (0.2251) -0.084  (0.1660) -0.073  (0.2447) -0.149  (0.0896)
week 4 -0.065  (0.2011) -0.059  (0.2081) -0.039  (0.2599) -0.059  (0.2024) -0.119  (0.2456) -0.079  (0.1122)
week 8 0.026  (0.2133) 0.002  (0.2320) 0.047  (0.3186) -0.024  (0.2767) -0.061  (0.3035) -0.034  (0.1874)
week 12 0.054  (0.1722) -0.036  (0.3260) 0.027  (0.3375) -0.013  (0.2587) -0.045  (0.2680) -0.070  (0.1488)
week 24 0.007  (0.2073) -0.046  (0.2601) 0.001  (0.2936) 0.018  (0.2453) -0.058  (0.2505) -0.062  (0.1691)
12.Primary Outcome
Title Change in Hematocrit From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: percentage of Total
week 1 -1.16  (1.446) -0.50  (2.429) -0.35  (1.280) -1.81  (2.05) -1.38  (2.155) -0.59  (1.499)
week 2 -0.19  (1.552) -0.49  (2.086) -0.33  (1.991) -0.52  (2.004) -0.80  (2.267) -1.47  (0.647)
week 4 -0.59  (1.492) -0.41  (2.004) 0.15  (2.091) -0.41  (2.339) -1.26  (2.160) -0.78  (0.986)
week 8 0.26  (1.950) .047  (2.132) 0.85  (2.857) -0.04  (2.790) -0.91  (2.775) 0.05  (2.017)
week 12 0.31  (1.594) -0.32  (3.175) 0.61  (2.312) -0.13  (2.819) -0.49  (2.511) -0.59  (1.470)
week 24 0.21  (1.758) -0.29  (2.534) 0.62  (2.020) 0.32  (2.511) -0.81  (2.255) -0.79  (1.389)
13.Primary Outcome
Title Change in Platelets From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: 10^9 Platelets /L
week 1 7.7  (19.56) -0.1  (24.38) 1.5  (27.38) -3.2  (16.20) -8.1  (12.15) 2.3  (21.86)
week 2 17.4  (25.92) 10.5  (33.06) 20.3  (24.62) 4.6  (17.77) 2.7  (16.23) 6.5  (14.79)
week 4 4.3  (22.90) -0.2  (22.27) 6.1  (24.28) -0.1  (22.93) -1.8  (17.76) 6.2  (16.23)
week 8 11.0  (22.90) 8.2  (31.41) 14.2  (23.86) -3.8  (24.07) 2.0  (14.11) 9.4  (28.11)
week 12 15.9  (31.26) 6.0  (30.25) 13.3  (27.51) -7.1  (21.05) -6.3  (16.19) 0.1  (17.94)
week 24 11.3  (30.27) 11.3  (36.34) 5.9  (18.30) -2.7  (31.25) 1.9  (19.30) -4.4  (24.42)
14.Primary Outcome
Title Change in Hemoglobin From Baseline
Hide Description [Not Specified]
Time Frame Weeks 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: g/L
week 1 -3.6  (5.21) -2.1  (6.31) -2.3  (4.89) -4.5  (5.70) -1.7  (7.07) -2.2  (4.44)
week 2 -0.8  (5.54) -2.6  (6.33) -2.8  (6.14) -3.3  (5.51) -2.1  (7.45) -3.0  (3.25)
week 4 -2.3  (5.86) -4.8  (6.05) -5.8  (6.66) -1.6  (6.55) -1.9  (7.52) 1.5  (5.01)
week 8 3.5  (6.15) -2.9  (6.61) -0.9  (8.20) 0.3  (7.84) -1.6  (9.45) 2.4  (4.87)
week 12 -2.0  (4.93) -2.6  (8.94) 0.1  (8.71) 1.8  (8.07) 0.6  (7.89) 0.3  (5.74)
week 24 -0.8  (6.13) -3.1  (7.55) 0.1  (8.09) 2.8  (6.97) -0.2  (7.88) -0.1  (5.45)
15.Primary Outcome
Title Change in Sodium From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: mmol/L
week 1 -0.1  (1.33) 0.6  (2.06) 0.3  (2.29) 0.3  (1.65) 0.6  (1.92) 1.8  (1.97)
week 2 0.6  (1.72) 0.4  (2.32) 0.3  (1.79) 0.3  (221) -0.5  (1.85) 1.5  (1.96)
week 4 0.5  (1.36) -1.6  (1.96) 0.1  (1.39) -1.1  (1.18) 0.6  (1.92) 0.8  (2.21)
week 8 0.0  (1.56) -0.5  (1.81) -0.1  (2.03) -0.7  (182) 0.5  (2.07) 0.3  (2.26)
week 12 -0.2  (1.37) -0.9  (1.25) 1.1  (2.31) -0.8  (1.84) -0.2  (2.11) 1.8  (1.47)
week 24 0.8  (1.86) -0.3  (2.19) 1.8  (2.01) 0.1  (1.85) 0.9  (1.85) 2.1  (2.14)
16.Primary Outcome
Title Change in Potassium From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: mmol/L
week 1 0.125  (0.3070) -0.007  (0.3696) 0.189  (0.4025) 0.036  (0.3269) 0.239  (0.5699) -0.158  (0.3481)
week 2 0.057  (0.2369) -0.037  (0.2778) 0.064  (0.2900) -0.049  (0.4433) -0.137  (0.4979) -0.089  (0.3626)
week 4 0.036  (0.3004) -0.195  (0.2952) 0.113  (0.34446) 0.023  (0.4688) -0.023  (0.4196) -0.227  (0.3090)
week 8 -0.028  (0.3874) 0.045  (0.3680) 0.241  (0.3395) -0.008  (0.4328) 0.271  (0.3383) -0.209  (0.3582)
week 12 0.040  (0.4153) -0.205  (0.4556) 0.217  (0.2773) 0.072  (0.3896) 0.089  (0.2322) -0.110  (0.2961)
week 24 0.061  (0.2474) 0.161  (0.2367) 0.324  (0.2924) 0.023  (0.2988) 0.253  (0.410) -0.190  (0.3313)
17.Primary Outcome
Title Change in Alkaline Phosphatase From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: U/L
week 1 2.1  (7.52) 0.7  (4.92) -3.7  (6.52) -4.9  (4.89) -0.7  (6.76) 0.9  (6.94)
week 2 0.5  (7.06) 2.0  (6.63) -4.7  (6.43) -1.8  (5.39) -4.3  (5.61) 0.3  (7.62)
week 4 1.3  (9.62) -0.4  (5.74) 3.6  (7.52) -2.4  (6.31) -2.7  (6.60) 3.2  (4.21)
week 8 5.0  (6.31) 2.5  (5.36) 1.1  (6.35) -2.4  (5.94) 3.5  (6.24) 4.1  (5.65)
week 12 2.7  (11.92) 3.2  (5.91) 3.9  (7.81) -1.1  (5.48) -2.1  (10.02) 0.1  (6.02)
week 24 1.7  (8.17) 5.3  (9.49) 3.3  (9.50) -1.7  (7.01) 2.1  (11.48) 2.3  (8.48)
18.Primary Outcome
Title Change in Alanine Aminotransferase From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: U/L
week 1 1.3  (6.69) 2.3  (6.33) -0.2  (2.91) -1.8  (2.44) 4.3  (20.30) 0.2  (3.55)
week 2 2.7  (16.39) 2.0  (5.13) 2.5  (5.25) -1.1  (3.26) 2.6  (3.98) 0.9  (3.68)
week 4 1.1  (10.91) 2.9  (3.81) 0.9  (6.65) 0.9  (3.96) 0.1  (3.84) 0.7  (4.43)
week 8 1.2  (12.13) 4.1  (6.08) 0.1  (5.46) -1.4  (5.26) 0.8  (7.02) -0.1  (2.99)
week 12 6.9  (12.59) 4.9  (6.33) 3.9  (9.84) -0.5  (8.22) 0.4  (3.76) -1.1  (3.23)
week 24 -0.7  (11.81) 1.2  (4.20) 0.3  (10.26) 10.  (3.38) -0.3  (6.31) -0.9  (3.83)
19.Primary Outcome
Title Change in Aspartate Aminotransferase From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: U/L
week 1 -1.60  (4.982) 0.40  (4.768) -0.40  (2.898) -1.38  (4.530) 3.93  (11.738) -1.33  (2.380)
week 2 9.07  (32.288) 0.29  (3.106) 2.27  (3.262) -2.44  (5.151) 0.07  (3.150) -0.80  (3.649)
week 4 -0.13  (4.518) 2.53  (3.067) 0.87  (4.015) 0.69  (4.191) 1.47  (3.720) -0.93  (3.240)
week 8 1.07  (4.480) 1.20  (5.735) 1.13  (3.623) -2.50  (4.487) 1.13  (4.340) -0.93  (3.411)
week 12 2.73  (6.147) 2.47  (4.533) 2.20  (4.109) .194  (4.106) -0.20  (3.986) 0.13  (3.739)
week 24 0.33  (6.091) 0.87  (2.774) 0.07  (5.391) -1.53  (4.357) 4.27  (18.763) -0.29  (3.384)
20.Primary Outcome
Title Change in Direct Bilirubin Form Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: umol/L
week 1 0.1026  (0.9712) -0.3420  (0.9950) -0.2622  (1.5375) -0.0214  (1.0992) 0.2280  (0.8878) 0.2280  (0.8419)
week 2 0.4140  (0.8857) 4.5942  (17.8620) -0.1482  (1.1559) -0.1603  (0.6767) -0.0684  (0.05040) -0.0570  (0.7129)
week 4 0.1140  (0.7907) 0.3762  (0.9053) -0.1710  (1.6503) -0.0107  (0.7835) 0.0570  (0.7331) -0.1254  (0.8802)
week 8 0.6498  (0.8155) 0.2394  (0.9362) -0.1026  (1.8449) 0.0962  (1.1945) 0.0570  (0.8783) 0.1140  (0.6452)
week 12 0.4789  (1.4059) 0.1938  (0.9209) -0.3534  (1.3718) -0.1603  (0.8365) -0.6270  (0.7720) -0.0228  (0.8547)
week 24 0.0114  (0.8610) 0.0689  (0.9883) -0.1482  (2.1081) 0.1254  (0.9531) -0.0342  (1.2181) 0.1710  (0.6938)
21.Primary Outcome
Title Change in Bilirubin From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: umol/L
week 1 0.3534  (3.7254) -1.1970  (3.7725) 0.1048  (5.4294) 0.0641  (4.2155) -0.0228  (3.5705) 0.5586  (2.8697)
week 2 1.1286  (3.4315) -0.1938  (3.5435) -0.1824  (4.4841) -0.4275  (2.54871) -0.7980  (1.7181) -0.7069  (2.5436)
week 4 -0.7068  (3.0527) 1.0146  (3.526) -0.2736  (6.4174) 0.1176  (2.9557) -0.0456  (2.7064) -0.6954  (2.9706)
week 8 2.1546  (3.7037) 0.2280  (3.2820) 0.2052  (7.1427) 0.0534  (3.9465) -0.5244  (3.0702) -0.3192  (1.9269)
week 12 1.9038  (6.9092) 0.3078  (3.7354) -0.6954  (5.6701) -1.1222  (2.5108) -2.6220  (2.8960) -0.3420  (3.1431)
week 24 -0.7524  (2.8223) 0.05586  (3.9258) 23.9286  (91.7547) -0.0114  (3.4670) -0.3078  (4.4235) -0.1954  (2.9227)
22.Primary Outcome
Title Change in Albumin Form Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: g/L
week 1 -2.45  (2.989) -0.65  (2.370) -1.70  (2.6376) -1.67  (2.775) 0.03  (2.343) -0.64  (2.346)
week 2 -0.01  (2.334) -0.83  (3.253) -1.37  (2.943) -1.03  (1.1885) -0.73  (2.504) -1.61  (1.739)
week 4 0.62  (3.150) -159  (2.035) -0.08  (2.486) -1.00  (2.055) -1.53  (2.707) -0.87  (2.408)
week 8 -0.23  (2.666) -2.07  (2.587) 0.71  (2.619) -1.47  (2.587) -2.43  (2.880) -0.45  (2.770)
week 12 -0.86  (2.442) -1.68  (2.815) -0.25  (2.167) -0.64  (2.2143) -0.93  (1.617) -0.13  (1.848)
week 24 -0.62  (2.155) -2.56  (2.201) -1.59  (2.630) -1.21  (2.811) -0.07  (3.501) 1.21  (2.598)
23.Primary Outcome
Title Change in Creatinine Form Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: umol/L
week 1 -0.6483  (5.2878) -2.9467  (5.8701) 1.4733  (3.9908) -4.0333  (8.5827) 1.2963  (9.553) -0.5304  (7.3491)
week 2 1.5323  (5.3404) -2.1805  (4.9992) 2.1216  (37176) 0.3315  (7.9125) 0.3536  (5.9657) -1.3555  (6.7561)
week 4 -2.3575  (4.4284) -4.2432  (4.7511) 1.6501  (5.2284) -2.4310  (8.9600) -1.8959  (6.6394) -1.7680  (5.9017)
week 8 2.2116  (6.3904) -0.3536  (5.6088) 2.4163  (3.0889) -3.228  (8.9278) -1.5912  (4.6442) -2.1216  (5.4779)
week 12 0.5893  (6.8610) -2.8288  (5.5929) 1.1787  (3.2680) -3.0940  (10.4097) -4.4789  (6.7279) -3.2413  (5.6175)
week 24 -4.9504  (5.6088) -2.0037  (4.6112) -0.11799  (5.382) -4.2432  (9.2244) -3.1824  (5.9751) -1.6417  (7.1888)
24.Primary Outcome
Title Change in Lactate Dehydrogenase From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: U/L
week 1 -3.5  (12.69) 0.5  (20.00) 6.5  (15.62) -10.8  (17.09) -2.6  (19.82) 0.9  (14.11)
week 2 8.4  (35.25) 1.4  (21.89) 7.3  (17.99) -7.0  (20.64) -10.9  (13.17) -5.7  (16.18)
week 4 -3.0  (16.46) -1.7  (18.67) 5.1  (15.34) 2.1  (12.37) 1.3  (17.54) -3.9  (19.78)
week 8 -4.3  (10.31) -2.4  (16.82) 14.2  (24.40) -11.2  (17.86) 3.7  (37.19) -4.2  (17.31)
week 12 -9.1  (13.48) -3.8  (20.23) 1.3  (16.86) -10.1  (17.55) -8.9  (15.95) -3.4  (23.85)
week 24 -9.4  (18.26) -3.3  (20.58) -2.1  (12.06) -10.0  (19.42) -3.1  (22.96) 2.4  (25.13)
25.Primary Outcome
Title Change in Urea Nitrogen From Baseline
Hide Description [Not Specified]
Time Frame week 1,2,4,8,12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 15 15 15 16 15 15
Mean (Standard Deviation)
Unit of Measure: mmol/L
week 1 0.0571  (1.9802) 0.0524  (1.5732) -0.5712  (2.7988) 0.1428  (2.0927) -0.4712  (1.5268) -0.3237  (2.4570)
week 2 0.2951  (1.9132) 0.5284  (2.2289) -0.9377  (3.3246) -0.2365  (2.2977) 0.7854  (1.2804) -0.6378  (2.4125)
week 4 0.1571  (2.2931) -0.1856  (1.6149) -0.1428  (2.3668) -0.3570  (2.0358) -0.6474  (1.8290) -0.5807  (2.3925)
week 8 -0.4522  (2.0612) -0.0286  (1.5584) -0.0952  (2.322) -0.0759  (2.3484) -1.0900  (2.3572) 0.3237  (2.1001)
week 12 -0.0143  (1.8835) 0.1000  (2.1727) -0.6045  (2.6703) 0.3525  (2.3561) -0.4667  (2.1063) -0.6426  (1.9342)
week 24 -0.0619  (1.7148) 0.2667  (2.8833) -0.5331  (2.3939) 0.5379  (2.3910) -0.2999  (1.5902) -0.1989  (2.9145)
26.Secondary Outcome
Title Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
Hide Description

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine

Immunogenicity Result: Seroconversion for Anti-S Antibody

Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.

Time Frame week 1, 2, 4, 8, 12, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
  • One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS).
  • One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS.
  • Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 14 15 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
week 1 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
indeterminate
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
week 2 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
8
  57.1%
7
  46.7%
8
  53.3%
4
  26.7%
5
  33.3%
5
  33.3%
negative
6
  42.9%
7
  46.7%
6
  40.0%
10
  66.7%
7
  46.7%
9
  60.0%
indeterminate
0
   0.0%
1
   6.7%
1
   6.7%
1
   6.7%
3
  20.0%
1
   6.7%
week 4 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
13
  92.9%
14
  93.3%
13
  86.7%
14
  93.3%
14
  93.3%
14
  93.3%
negative
1
   7.1%
0
   0.0%
2
  13.3%
1
   6.7%
1
   6.7%
1
   6.7%
indeterminate
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
week 8 Number Analyzed 14 participants 15 participants 14 participants 15 participants 15 participants 15 participants
positive
13
  92.9%
14
  93.3%
14
 100.0%
10
  66.7%
12
  80.0%
13
  86.7%
negative
1
   7.1%
1
   6.7%
0
   0.0%
3
  20.0%
3
  20.0%
1
   6.7%
indeterminate
0
   0.0%
0
   0.0%
0
   0.0%
2
  13.3%
0
   0.0%
1
   6.7%
week 12 Number Analyzed 14 participants 15 participants 14 participants 15 participants 15 participants 15 participants
positive
13
  92.9%
13
  86.7%
13
  92.9%
10
  66.7%
11
  73.3%
13
  86.7%
negative
1
   7.1%
2
  13.3%
1
   7.1%
4
  26.7%
4
  26.7%
2
  13.3%
indeterminate
0
   0.0%
0
   0.0%
0
   0.0%
1
   6.7%
0
   0.0%
0
   0.0%
week 24 Number Analyzed 14 participants 13 participants 13 participants 12 participants 13 participants 13 participants
positive
10
  71.4%
7
  53.8%
11
  84.6%
6
  50.0%
5
  38.5%
10
  76.9%
negative
4
  28.6%
4
  30.8%
1
   7.7%
6
  50.0%
6
  46.2%
3
  23.1%
indeterminate
0
   0.0%
2
  15.4%
1
   7.7%
0
   0.0%
2
  15.4%
0
   0.0%
27.Secondary Outcome
Title Number of Participants With Positive, Negative Anti-n Antibody
Hide Description

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine

cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline

Time Frame week 1, 2, 4, 8, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
  • One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS).
  • One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS.
  • Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 14 15 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
week 1 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
week 2 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
week 4 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
week 8 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
week 12 Number Analyzed 14 participants 15 participants 14 participants 15 participants 15 participants 15 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
15
 100.0%
14
 100.0%
15
 100.0%
15
 100.0%
15
 100.0%
week 24 Number Analyzed 14 participants 13 participants 13 participants 12 participants 13 participants 13 participants
positive
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
negative
14
 100.0%
13
 100.0%
13
 100.0%
12
 100.0%
13
 100.0%
13
 100.0%
28.Secondary Outcome
Title Number of Participants With Positive, Negative for Micro Neutralization Test
Hide Description

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test

Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline

Time Frame week 4 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 14 15 15 15 15 15
Measure Type: Count of Participants
Unit of Measure: Participants
positive week 4 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
6
  42.9%
10
  66.7%
9
  60.0%
12
  80.0%
10
  66.7%
11
  73.3%
Negative week 4 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
8
  57.1%
5
  33.3%
6
  40.0%
3
  20.0%
5
  33.3%
4
  26.7%
Positive week 24 Number Analyzed 14 participants 13 participants 13 participants 12 participants 13 participants 13 participants
2
  14.3%
4
  30.8%
5
  38.5%
2
  16.7%
4
  30.8%
6
  46.2%
Negative week 24 Number Analyzed 14 participants 13 participants 13 participants 12 participants 13 participants 13 participants
12
  85.7%
9
  69.2%
8
  61.5%
10
  83.3%
9
  69.2%
7
  53.8%
29.Secondary Outcome
Title Immunogenicity - T-cell Response
Hide Description

To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated.

T-cells were evaluated on frozen and fresh (week2) samples

Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints

Unit: spot-forming cells [SFC]/1 × 10^6 peripheral blood mononuclear cell [PBMC]

Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.

Time Frame baseline, week 2, week 4, week 8, week 12, week 24
Hide Outcome Measure Data
Hide Analysis Population Description
number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description:

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=14

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Overall Number of Participants Analyzed 14 15 15 15 15 15
Median (Inter-Quartile Range)
Unit of Measure: SFC/1x10^6 PBMC
T-cell response baseline Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
54
(23.0 to 88.0)
88.0
(43.0 to 138.0)
128.0
(65.0 to 213.0)
320.0
(78.0 to 760.0)
165.0
(128.0 to 565.0)
425.0
(295.0 to 1050.0)
T-cell response week 2 (fresh samples) Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
1161.0
(438.0 to 2430.0)
2857.0
(412.0 to 4702.0)
2272.0
(1243.0 to 3568.0)
1917.0
(1353.0 to 3613.0)
2262.0
(1228.0 to 3942.0)
3142.0
(1555.0 to 8265.0)
T-cell response week 2 (frozen samples) Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
1214.0
(465.0 to 1475.0)
1095.0
(328.0 to 3083.0)
905.0
(743.0 to 1465.0)
1258.0
(975.0 to 2790.0)
1363.0
(570.0 to 2285.0)
1618.0
(1010.0 to 5785.0)
T-cell response week 4 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
788.0
(425.0 to 1353.0)
1120.0
(368.0 to 2193.0)
1330.0
(573.0 to 2285.0)
1153.0
(745.0 to 2188.0)
1258.0
(395.0 to 2000.0)
1645.0
(1183.0 to 4215.0)
T-cell response week 8 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
720.0
(355.0 to 945.0)
948.0
(329.0 to 1468.0)
1172.0
(628.0 to 1570.0)
898.0
(403.0 to 1273.0)
888.0
(353.0 to 1920.0)
2133.0
(945.0 to 3538.0)
T-cell response week 12 Number Analyzed 14 participants 15 participants 15 participants 15 participants 15 participants 15 participants
570.0
(458.0 to 733.0)
655.0
(368.0 to 1073.0)
856.0
(570.0 to 1553.0)
898.0
(435.0 to 1670.0)
835.0
(358.0 to 1278.0)
1435.0
(760.0 to 2943.0)
T-cell response week 24 Number Analyzed 14 participants 13 participants 13 participants 12 participants 13 participants 13 participants
538.0
(243.0 to 693.0)
500.0
(238.0 to 918.0)
798.0
(220.0 to 968.0)
740.5
(529.0 to 936.5)
643.0
(468.0 to 823.0)
1223.0
(823.0 to 1930.0)
Time Frame Adverse Event occurred during the study period from enrollment to week 24
Adverse Event Reporting Description

Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences.

Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.

 
Arm/Group Title Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Hide Arm/Group Description

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

GRAd-COV2: Single intramuscular administration.

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

GRAd-COV2: Single intramuscular administration.

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

GRAd-COV2: Single intramuscular administration.

All-Cause Mortality
Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/16 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Serious Adverse Events
Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/15 (0.00%)      0/15 (0.00%)      0/15 (0.00%)      0/16 (0.00%)      0/15 (0.00%)      0/15 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1 - Low Dose Arm 2 - Intermediate Dose Arm 3 - High Dose Arm 4 - Low Dose Arm 5 - Intermediate Dose Arm 6 - High Dose
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/15 (80.00%)      14/15 (93.33%)      14/15 (93.33%)      13/16 (81.25%)      9/15 (60.00%)      9/15 (60.00%)    
Blood and lymphatic system disorders             
Neutropoenia  1  1/15 (6.67%)  2 1/15 (6.67%)  1 2/15 (13.33%)  2 1/16 (6.25%)  2 1/15 (6.67%)  1 2/15 (13.33%)  2
Lymphadenopathy  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Eye disorders             
Chalazion  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Gastrointestinal disorders             
Nausea  1  2/15 (13.33%)  3 4/15 (26.67%)  4 3/15 (20.00%)  3 1/16 (6.25%)  3 3/15 (20.00%)  3 2/15 (13.33%)  2
Diarrhoea  1  2/15 (13.33%)  2 4/15 (26.67%)  4 3/15 (20.00%)  3 0/16 (0.00%)  0 2/15 (13.33%)  2 0/15 (0.00%)  0
Abdominal Pain  1  1/15 (6.67%)  1 4/15 (26.67%)  5 0/15 (0.00%)  0 1/16 (6.25%)  1 1/15 (6.67%)  1 0/15 (0.00%)  0
Faeces Soft  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Vomiting  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
General disorders             
Fatigue  1  9/15 (60.00%)  31 7/15 (46.67%)  35 10/15 (66.67%)  11 7/16 (43.75%)  13 3/15 (20.00%)  4 4/15 (26.67%)  4
injection site pain  1  10/15 (66.67%)  11 12/15 (80.00%)  14 10/15 (66.67%)  10 2/16 (12.50%)  3 1/15 (6.67%)  1 4/15 (26.67%)  4
Pyrexia  1  3/15 (20.00%)  5 4/15 (26.67%)  6 11/15 (73.33%)  15 5/16 (31.25%)  6 4/15 (26.67%)  11 4/15 (26.67%)  4
Chills  1  1/15 (6.67%)  1 2/15 (13.33%)  2 6/15 (40.00%)  6 4/16 (25.00%)  7 4/15 (26.67%)  4 6/15 (40.00%)  7
Injection Site Erithema  1  1/15 (6.67%)  1 2/15 (13.33%)  2 2/15 (13.33%)  2 0/16 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Injection Site swelling  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Injection Site hematoma  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Infections and infestations             
Conjunctivitis  1  1/15 (6.67%)  2 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Oral Herpes  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Tooth Abscess  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Injury, poisoning and procedural complications             
Muscle injury  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Muscle Strain  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Tooth Fracture  1  0/15 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Investigations             
Aspartate Aminotransferase increased  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Metabolism and nutrition disorders             
Hyperkaliemia  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders             
Myalgia  1  1/15 (6.67%)  1 6/15 (40.00%)  6 4/15 (26.67%)  4 6/16 (37.50%)  12 1/15 (6.67%)  1 5/15 (33.33%)  5
Neck Pain  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0
Arthralgia  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Muscle contracture  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Spinal Pain  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Back Pain  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 1/16 (6.25%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0
Nervous system disorders             
Headache  1  6/15 (40.00%)  11 8/15 (53.33%)  16 11/15 (73.33%)  15 7/16 (43.75%)  10 3/15 (20.00%)  4 2/15 (13.33%)  2
Paraesthesia  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Reproductive system and breast disorders             
Dysmenorrhoea  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Premenstrual Syndrome  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Respiratory, thoracic and mediastinal disorders             
Cough  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 2/15 (13.33%)  3
Dyspnoea  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 1/15 (6.67%)  1
Oropharyngeal Pain  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Skin and subcutaneous tissue disorders             
Pruritus  1  0/15 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 2/15 (13.33%)  2 0/15 (0.00%)  0
Ecchymosis  1  0/15 (0.00%)  0 1/15 (6.67%)  1 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
Vascular disorders             
Hot Flush  1  1/15 (6.67%)  1 0/15 (0.00%)  0 0/15 (0.00%)  0 0/16 (0.00%)  0 0/15 (0.00%)  0 0/15 (0.00%)  0
1
Term from vocabulary, MedDRA v. 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication of the results will be agreed between ReiThera SRL and Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani. If one of the parties is interested in proceeding with a scientific publication, it must give written and electronic communication to the other party. Any impediments to publication must be communicated electronically within 30 days. If a party deems it inappropriate to publish, it will try to provide written changes to the text that could allow its publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Reithera
Phone: 06 99775 ext 352
EMail: roberto.camerini@reithera.com
Layout table for additonal information
Responsible Party: ReiThera Srl
ClinicalTrials.gov Identifier: NCT04528641    
Other Study ID Numbers: RT-CoV-2
First Submitted: August 19, 2020
First Posted: August 27, 2020
Results First Submitted: January 17, 2022
Results First Posted: February 8, 2022
Last Update Posted: February 8, 2022