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Safety and Efficacy of C21 in Subjects With COVID-19

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: NCT04452435
Recruitment Status : Completed
First Posted : June 30, 2020
Results First Posted : April 30, 2021
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
Orphan Reach
Information provided by (Responsible Party):
Vicore Pharma AB

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: C21
Drug: Placebo
Enrollment 206
Recruitment Details  
Pre-assignment Details

96 enrolled subjects were screening failures because inclusion criteria 4 was not met.

2 enrolled subjects decided to withdraw from the trial before randomization. 2 subjects died before randomization (pneumonia). The remaining 106 subjects were randomized to trial treatment.

Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description Oral C21 treatment 100 mg twice daily for 7 days Oral placebo treatment twice daily for 7 days
Period Title: Screening
Started 51 55
Completed 51 55
Not Completed 0 0
Period Title: Treatment Period
Started 51 55
Completed 45 43
Not Completed 6 12
Period Title: Follow-up
Started 45 43
Completed 45 42
Not Completed 0 1
Arm/Group Title C21 Treatment Placebo Treatment Total
Hide Arm/Group Description Oral C21 treatment 100 mg twice daily for 7 days Oral placebo treatment twice daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 51 55 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 51 participants 55 participants 106 participants
54.3
(29 to 68)
51.1
(22 to 68)
52.6
(22 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
Female
13
  25.5%
13
  23.6%
26
  24.5%
Male
38
  74.5%
42
  76.4%
80
  75.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
51
 100.0%
55
 100.0%
106
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
51
 100.0%
55
 100.0%
106
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 51 participants 55 participants 106 participants
51 55 106
Height  
Mean (Full Range)
Unit of measure:  Cm
Number Analyzed 51 participants 55 participants 106 participants
166.1
(132 to 198)
166.0
(143 to 188)
166.1
(132 to 198)
Weight  
Mean (Full Range)
Unit of measure:  Kg
Number Analyzed 51 participants 55 participants 106 participants
70.1
(46 to 116)
69.2
(47 to 112)
69.6
(46 to 116)
Body mass index  
Mean (Full Range)
Unit of measure:  Kg/m^2
Number Analyzed 51 participants 55 participants 106 participants
25.4
(15 to 41)
25.1
(20 to 34)
25.2
(15 to 41)
Supplemental oxygen use at baseline   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
29
  56.9%
32
  58.2%
61
  57.5%
[1]
Measure Description: Number of subjects in use of supplemental oxygen use at baseline
CRP value ≤ median   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
24
  47.1%
22
  40.0%
46
  43.4%
[1]
Measure Description: Number of subjects with baseline CRP value ≤ median
CRP value > median   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 51 participants 55 participants 106 participants
21
  41.2%
25
  45.5%
46
  43.4%
[1]
Measure Description: Number of subjects with baseline CRP value > median
1.Primary Outcome
Title Change From Baseline in C-reactive Protein (CRP) After Treatment With C21 200 mg Daily Dose (100 mg b.i.d.)
Hide Description Change in C-reactive protein (CRP) from baseline to the average of the last two assessments in the treatment period
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set. A total of 45 subjects in the C21 group and 46 subjects in the placebo group were included in the analysis of the primary endpoint in the FAS. For a number of the excluded subjects, the reason for exclusion from the primary endpoint analysis was that they had no baseline value available.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 45 46
Least Squares Mean (90% Confidence Interval)
Unit of Measure: mg/L
0.19
(0.14 to 0.25)
0.22
(0.17 to 0.29)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.4891
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments A subgroup analyses was performed in subjects with supplemental oxygen use at baseline. A total of 26 subjects in the C21 group and 27 in the placebo group were included in the analysis of change in CRP from baseline to the mean of the last 2 non-missing scheduled assessments during the treatment period by baseline supplemental oxygen use.
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.0881
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Body Temperature
Hide Description Change in body temperature from baseline to the average of the last two assessments in the treatment period
Time Frame Treatment period of 7 days ((Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 51 54
Least Squares Mean (90% Confidence Interval)
Unit of Measure: °C
-0.11
(-0.25 to 0.02)
-0.34
(-0.47 to -0.21)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.0492
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
3.Secondary Outcome
Title Change From Baseline in IL-6
Hide Description Change in IL-6 from baseline to the average of the last two assessments during the treatment period
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 31 34
Least Squares Mean (90% Confidence Interval)
Unit of Measure: pg/mL
0.73
(0.51 to 1.05)
0.73
(0.51 to 1.03)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.9923
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
4.Secondary Outcome
Title Change From Baseline in IL-10
Hide Description Change in IL-10 from baseline to the average of the last two assessments during the treatment period
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 37 39
Least Squares Mean (90% Confidence Interval)
Unit of Measure: pg/mL
0.66
(0.54 to 0.8)
0.73
(0.6 to 0.89)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.5355
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in TNF
Hide Description Change in TNF from baseline to the average of the last two assessments during the treatment period.
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 46 46
Least Squares Mean (90% Confidence Interval)
Unit of Measure: pg/mL
0.91
(0.77 to 1.07)
1.01
(0.86 to 1.19)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.4738
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in CA125
Hide Description Change in CA125 from baseline to the average of the last two assessments in the treatment period
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 46 48
Least Squares Mean (90% Confidence Interval)
Unit of Measure: u/mL
1.16
(1.04 to 1.31)
1.17
(1.05 to 1.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.9418
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in Ferritin
Hide Description Change in Ferritin from baseline to the average of the last two assessments during the treatment period.
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 46 47
Least Squares Mean (90% Confidence Interval)
Unit of Measure: ng/mL
0.75
(0.66 to 0.84)
0.74
(0.66 to 0.84)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.9733
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
8.Secondary Outcome
Title Number of Subjects Not in Need of Oxygen Supply
Hide Description Number of subjects not in need of oxygen supply at the end of treatment
Time Frame End-of treatment, Day 7 or 8
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 51 55
Measure Type: Count of Participants
Unit of Measure: Participants
37
  72.5%
30
  54.5%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.0568
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects Not in Need of Mechanical Invasive or Non-invasive Ventilation
Hide Description Number of subjects not in need of mechanical invasive or non-invasive ventilation during the treatment period
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 51 55
Measure Type: Count of Participants
Unit of Measure: Participants
50
  98.0%
53
  96.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.6088
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
10.Secondary Outcome
Title Time to Need of Mechanical Invasive or Non-invasive Ventilation
Hide Description Time to need of mechanical invasive or non-invasive ventilation during treatment period
Time Frame Treatment period of 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with measurements were included in the analysis for the full analysis set.
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 1 2
Mean (Full Range)
Unit of Measure: hours
60.0
(60.0 to 60.0)
77.925
(59.98 to 95.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.5757
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
11.Secondary Outcome
Title Time on Oxygen Supply (for Those Not Needing Mechanical Invasive or Non-invasive Ventilation)
Hide Description Time on oxygen supply during the treatment period (for those not needing mechanical invasive or non-invasive ventilation)
Time Frame Treatment period of 7 days (Day 1 to Day 8)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 51 55
Median (Inter-Quartile Range)
Unit of Measure: days
5.0
(1.0 to 7.0)
5.0
(1.0 to 7.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.8588
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
12.Secondary Outcome
Title Adverse Events
Hide Description Adverse events were reported from signing of informed consent until end-of-trial visit. No AEs were reported from signing of informed consent until randomization, except for 2 fatal SAEs described under Adverse events.
Time Frame Day 1 to end-of-trial (Visit 9)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 51 55
Measure Type: Count of Participants
Unit of Measure: Participants
31
  60.8%
37
  67.3%
13.Post-Hoc Outcome
Title Oxygen Supplementation at Day 14
Hide Description Number of subjects requiring oxygen supplementation at Day 14
Time Frame Follow-up Day 14 (7 days after end-of-treatment)
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set
Arm/Group Title C21 Treatment Placebo Treatment
Hide Arm/Group Description:
Oral C21 treatment 100 mg twice daily for 7 days
Oral placebo treatment twice daily for 7 days
Overall Number of Participants Analyzed 51 55
Measure Type: Count of Participants
Unit of Measure: Participants
1
   2.0%
11
  20.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection C21 Treatment, Placebo Treatment
Comments [Not Specified]
Type of Statistical Test Equivalence
Comments The null hypothesis was that the treatments were equivalent and was to be rejected in favour of the alternative hypothesis that a treatment difference existed, if the probability of the null hypothesis being true was less than 10%.
Statistical Test of Hypothesis P-Value =0.003
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame From signing of informed consent until end-of-trial visit, 14-19 days.
Adverse Event Reporting Description At each visit, the subject was asked about AEs in an objective manner, e.g., "Have you experienced any problems since the last visit?" No AEs were reported from signing of informed consent until randomization except for 2 fatal SAEs.
 
Arm/Group Title C21 Treatment Placebo Treatment No Treatment (Before Randomization)
Hide Arm/Group Description Oral C21 treatment 100 mg twice daily for 7 days Oral placebo treatment twice daily for 7 days Subjects that were enrolled in the trial but not randomized
All-Cause Mortality
C21 Treatment Placebo Treatment No Treatment (Before Randomization)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/51 (1.96%)      3/55 (5.45%)      2/100 (2.00%)    
Hide Serious Adverse Events
C21 Treatment Placebo Treatment No Treatment (Before Randomization)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/51 (1.96%)      3/55 (5.45%)      2/100 (2.00%)    
Cardiac disorders       
Cardio-respiratory arrest  1 [1]  1/51 (1.96%)  1 1/55 (1.82%)  1 0/100 (0.00%)  0
Infections and infestations       
COVID-19 pneumonia  1 [1]  0/51 (0.00%)  0 2/55 (3.64%)  2 2/100 (2.00%)  2
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
[1]
The events had a fatal outcome
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
C21 Treatment Placebo Treatment No Treatment (Before Randomization)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/51 (58.82%)      36/55 (65.45%)      0/100 (0.00%)    
Gastrointestinal disorders       
Constipation  1  0/51 (0.00%)  0 4/55 (7.27%)  4 /100 
Investigations       
Aspartate aminotransferase increased  1  6/51 (11.76%)  6 3/55 (5.45%)  4 /100 
Blood glucose increased  1  5/51 (9.80%)  7 3/55 (5.45%)  3 /100 
Interleukin level increased  1  4/51 (7.84%)  6 4/55 (7.27%)  4 /100 
Alanine aminotransferase increased  1  3/51 (5.88%)  3 4/55 (7.27%)  5 /100 
Serum ferritin increased  1  5/51 (9.80%)  5 2/55 (3.64%)  2 /100 
Alpha tumour necrosis factor increased  1  1/51 (1.96%)  1 3/55 (5.45%)  3 /100 
Carbohydrate antigen 125 increased  1  0/51 (0.00%)  0 4/55 (7.27%)  4 /100 
Lymphocyte count decreased  1  1/51 (1.96%)  1 3/55 (5.45%)  4 /100 
Neutrophil count increased  1  1/51 (1.96%)  1 3/55 (5.45%)  5 /100 
Platelet count decreased  1  1/51 (1.96%)  1 3/55 (5.45%)  3 /100 
Blood alkaline phosphatase increased  1  1/51 (1.96%)  1 2/55 (3.64%)  2 /100 
Blood calcium decreased  1  1/51 (1.96%)  1 2/55 (3.64%)  2 /100 
Blood potassium increased  1  1/51 (1.96%)  1 2/55 (3.64%)  2 /100 
White blood cell count increased  1  0/51 (0.00%)  0 3/55 (5.45%)  4 /100 
Blood urea increased  1  0/51 (0.00%)  0 2/55 (3.64%)  2 /100 
Platelet count increased  1  0/51 (0.00%)  0 2/55 (3.64%)  2 /100 
Metabolism and nutrition disorders       
Hyperglycaemia  1  11/51 (21.57%)  14 4/55 (7.27%)  5 /100 
Hyponatraemia  1  2/51 (3.92%)  2 3/55 (5.45%)  3 /100 
Dyslipidaemia  1  1/51 (1.96%)  1 2/55 (3.64%)  2 /100 
Renal and urinary disorders       
Glycosuria  1  1/51 (1.96%)  1 3/55 (5.45%)  3 /100 
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Carl-Johan Dalsgaard
Organization: Vicore Pharma
Phone: +46 70 975 98 63
EMail: carl-johan.dalsgaard@vicorepharma.com
Layout table for additonal information
Responsible Party: Vicore Pharma AB
ClinicalTrials.gov Identifier: NCT04452435    
Other Study ID Numbers: VP-C21-006
2020-001502-38 ( EudraCT Number )
First Submitted: June 29, 2020
First Posted: June 30, 2020
Results First Submitted: March 24, 2021
Results First Posted: April 30, 2021
Last Update Posted: June 23, 2021