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A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 (EMPATHY)

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: NCT04828161
Recruitment Status : Terminated (Phase 2 completed as planned. Due to the evolving landscape of treatments for COVID-19, the placebo-controlled Phase 3 design will not proceed. No patients were actively participating at the time of termination.)
First Posted : April 1, 2021
Results First Posted : January 18, 2023
Last Update Posted : January 18, 2023
Sponsor:
Collaborator:
Molecular Partners AG
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition COVID-19
Interventions Drug: ensovibep
Drug: Placebo
Enrollment 407
Recruitment Details This study consisted of 2 parts, Part A and Part B. The Part A was Phase II proof of efficacy study conducted in ambulatory adult participants with symptomatic coronavirus disease 2019 (COVID-19) at 45 centers across 5 countries (Hungary, India, Netherlands, South Africa, and USA) between 10 May 2021 and 27 Jan 2022. The Part B was to be a Phase III confirmatory study. Only Part A analysis is reported since Part B of the study was not initiated.
Pre-assignment Details The Part A of the study consisted of a screening period (up to 3 days) followed by study treatment on Day 1. Participants were randomized in 1:1:1:1 ratio, stratified by risk for COVID-19 disease progression, to receive 1 of 4 study treatments (Ensovibep 600 mg or Ensovibep 225 mg or Ensovibep 75 mg or Placebo). A total of 407 participants were randomized in the study, of which 400 were treated.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Placebo
Hide Arm/Group Description Participants received single intravenous (IV) infusion of ensovibep 600 milligram (mg) on Day 1. Participants received single IV infusion of ensovibep 225 mg on Day 1. Participants received single IV infusion of ensovibep 75 mg on Day 1. Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Period Title: Overall Study
Started [1] 100 102 103 102
Completed 97 95 96 94
Not Completed 3 7 7 8
Reason Not Completed
Withdrawal by Subject             0             3             3             4
Lost to Follow-up             1             4             2             2
Other             2             0             2             0
Death             0             0             0             2
[1]
Randomized
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Placebo Total
Hide Arm/Group Description Participants received single IV infusion of ensovibep 600 mg on Day 1. Participants received single IV infusion of ensovibep 225 mg on Day 1. Participants received single IV infusion of ensovibep 75 mg on Day 1. Participants received single IV infusion of placebo matching with ensovibep on Day 1. Total of all reporting groups
Overall Number of Baseline Participants 100 100 101 99 400
Hide Baseline Analysis Population Description
Full analysis set (FAS) included all participants in the randomized set for whom IV infusion of study treatment was initiated during the treatment period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 101 participants 99 participants 400 participants
40.6  (11.50) 40.2  (12.90) 41.5  (12.84) 42.3  (13.75) 41.1  (12.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 101 participants 99 participants 400 participants
Female 47 54 60 57 218
Male 53 46 41 42 182
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 101 participants 99 participants 400 participants
White 59 63 62 63 247
Asian 14 14 13 16 57
Black or African American 16 11 14 11 52
Multiple 5 4 6 8 23
Not reported 1 4 3 1 9
Native Hawaiian or Other Pacific Islander 1 1 2 0 4
American Indian or Alaska Native 3 0 1 0 4
Unknown 1 3 0 0 4
1.Primary Outcome
Title Part A: Time-Weighted Change From Baseline in Log10 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load Through Day 8
Hide Description The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used. Time-weighted change from baseline was used as viral loads were measured at multiple time points.
Time Frame Baseline (Day 1) and Days 3, 5 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Placebo
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Overall Number of Participants Analyzed 89 97 97 87
Least Squares Mean (Standard Error)
Unit of Measure: log10 copies/milliliter (mL)
-1.99  (0.097) -1.73  (0.093) -1.81  (0.093) -1.40  (0.098)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ensovibep 600 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square (LS) mean difference
Estimated Value -0.59
Confidence Interval (2-Sided) 95%
-0.86 to -0.32
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.138
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ensovibep 225 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.33
Confidence Interval (2-Sided) 95%
-0.60 to -0.07
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.135
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ensovibep 75 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.42
Confidence Interval (2-Sided) 95%
-0.68 to -0.15
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.135
Estimation Comments [Not Specified]
2.Primary Outcome
Title Part B: Percentage of Participants With Hospitalizations and/or Emergency Room (ER) Visits Related to COVID-19 or Death From Any Cause
Hide Description Percentage of participants experiencing hospitalizations [>= 24 hour (h) of acute care] and/or ER visits related to COVID-19 or death from any cause up to Day 29.
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Arm/Group Title Phase 3/Part B: Ensovibep 75 mg Phase 3/Part B: Placebo
Hide Arm/Group Description:
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
Phase 3/Part B: Placebo. Part B was not initiated.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Part A: Percentage of Participants With Hospitalizations and/or ER Visits Related to COVID-19 or Death From Any Cause
Hide Description Percentage of participants experiencing hospitalizations (>= 24 h of acute care) and/or ER visits related to COVID-19 or death from any cause up to Day 29 were presented along with relative risk to placebo.
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Placebo
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Overall Number of Participants Analyzed 100 100 101 99
Measure Type: Number
Unit of Measure: percentage of participants
Any event 1.0 3.0 0.0 6.1
Hospitalizations (≥ 24 h of acute care) 0.0 2.0 0.0 5.1
Emergency room visits related to COVID-19 1.0 1.0 0.0 5.1
Death from any cause 0.0 0.0 0.0 2.0
4.Secondary Outcome
Title Part A: Time to Sustained Clinical Recovery
Hide Description

Sustained clinical recovery was defined as follows;

  1. All symptoms from the modified Food and Drug Administration (FDA) COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
  2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all participants in the randomized set for whom IV infusion of study treatment was administered. Only participants included in the analysis are reported.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Placebo
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Participants received single IV infusion of placebo matching with ensovibep on Day 1.
Overall Number of Participants Analyzed 63 66 74 70
Median (95% Confidence Interval)
Unit of Measure: days
23.0
(14.0 to 29.0)
15.0
(13.0 to 21.0)
14.0
(11.0 to 28.0)
29.0
(21.0 to 32.0)
5.Secondary Outcome
Title Part A: Observed Maximum Serum Concentration (Cmax) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the Cmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The Pharmacokinetic (PK) analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 94 92 95
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: microgram (mcg) per mL
Total Ensovibep Number Analyzed 94 participants 90 participants 93 participants
187
(25.3%)
70.4
(27.5%)
25.1
(38.4%)
Free Ensovibep Number Analyzed 94 participants 92 participants 95 participants
210
(26.3%)
78.1
(31.5%)
29.3
(46.4%)
6.Secondary Outcome
Title Part A: Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the AUClast of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 94 91 95
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*mcg/mL
Total Ensovibep Number Analyzed 94 participants 88 participants 95 participants
63300
(87.6%)
21100
(122.0%)
7950
(67.1%)
Free Ensovibep Number Analyzed 94 participants 91 participants 95 participants
68200
(84.4%)
22500
(126.9%)
8380
(67.9%)
7.Secondary Outcome
Title Part A: Area Under the Concentration-Time Curve From Time Zero to 48 Hours (AUC 0-48h) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the AUC 0-48h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 95 90 95
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*mcg/mL
Total Ensovibep Number Analyzed 93 participants 89 participants 95 participants
7520
(35.3%)
2830
(35.7%)
999
(34.4%)
Free Ensovibep Number Analyzed 95 participants 90 participants 95 participants
8290
(32.1%)
2800
(156.2%)
1120
(36.7%)
8.Secondary Outcome
Title Part A: Area Under the Concentration-Time Curve From Time Zero to 168 Hours (AUC 0-168h) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the AUC 0-168h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 95 89 95
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*mcg/mL
Total Ensovibep Number Analyzed 93 participants 89 participants 94 participants
23000
(23.7%)
8570
(33.1%)
3020
(31.4%)
Free Ensovibep Number Analyzed 95 participants 89 participants 95 participants
25200
(23.2%)
8940
(73.2%)
3390
(35.3%)
9.Secondary Outcome
Title Part A: Area Under the Concentration-Time Curve From Time Zero to 336 Hours (AUC 0-336h) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the AUC 0-336h of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8 and 15
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 95 88 94
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*mcg/mL
Total Ensovibep Number Analyzed 93 participants 87 participants 93 participants
38200
(23.2%)
13800
(37.6%)
5040
(31.9%)
Free Ensovibep Number Analyzed 95 participants 88 participants 94 participants
41800
(23.5%)
15300
(41.6%)
5620
(39.1%)
10.Secondary Outcome
Title Part A: Area Under the Concentration-Time Curve From Time Zero to Infinity (AUCinfinity) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the AUCinfinity of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 87 82 82
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*mcg/mL
Total Ensovibep Number Analyzed 87 participants 77 participants 82 participants
75400
(33.5%)
27600
(36.3%)
9930
(41.0%)
Free Ensovibep Number Analyzed 87 participants 82 participants 80 participants
80100
(40.6%)
29400
(34.8%)
9540
(45.8%)
11.Secondary Outcome
Title Part A: Time to Reach the Maximum Concentration (Tmax) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the Tmax of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 95 92 95
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
Total Ensovibep Number Analyzed 95 participants 90 participants 92 participants
0.935
(457.5%)
1.30
(693.5%)
1.05
(573.6%)
Free Ensovibep Number Analyzed 95 participants 92 participants 95 participants
1.01
(473.8%)
1.09
(516.6%)
1.24
(810.1%)
12.Secondary Outcome
Title Part A: Apparent Total Body Clearance (CL) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the CL of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 84 80 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL/h
Total Ensovibep Number Analyzed 77 participants 78 participants 74 participants
8.07
(35.4%)
8.11
(36.1%)
7.48
(42.1%)
Free Ensovibep Number Analyzed 84 participants 80 participants 74 participants
7.55
(37.3%)
7.64
(35.3%)
7.78
(43.0%)
13.Secondary Outcome
Title Part A: Terminal Elimination Rate Constant (Lambda z) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the lambda z of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 84 79 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: per hour
Total Ensovibep Number Analyzed 83 participants 70 participants 72 participants
0.003
(52.1%)
0.002
(50.6%)
0.002
(39.5%)
Free Ensovibep Number Analyzed 84 participants 79 participants 74 participants
0.003
(69.6%)
0.003
(48.3%)
0.003
(61.2%)
14.Secondary Outcome
Title Part A: Terminal Elimination Half-Life (T1/2) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the T1/2 of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 90 83 83
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour
Total Ensovibep Number Analyzed 89 participants 81 participants 83 participants
274
(54.0%)
290
(53.8%)
309
(39.8%)
Free Ensovibep Number Analyzed 90 participants 83 participants 81 participants
262
(67.7%)
234
(48.3%)
215
(60.6%)
15.Secondary Outcome
Title Part A: Apparent Volume of Distribution (Vz) of Total and Free Ensovibep
Hide Description Blood samples were collected to determine the Vz of free ensovibep (ensovibep not bound to target) and total ensovibep (sum of ensovibep not bound to and bound to target) concentrations in serum.
Time Frame Data was summarized from pre-dose and at 15 minutes and 90 minutes after end of study drug infusion on Day 1, and at Days 3, 8, 15, 29, 61 and 91
Hide Outcome Measure Data
Hide Analysis Population Description
The PK analysis set included all participants with at least 1 available valid (that is, not flagged for exclusion) PK concentration measurement, who received any study treatment and with no protocol deviations that impacted PK data.
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg
Hide Arm/Group Description:
Participants received single IV infusion of ensovibep 600 mg on Day 1.
Participants received single IV infusion of ensovibep 225 mg on Day 1.
Participants received single IV infusion of ensovibep 75 mg on Day 1.
Overall Number of Participants Analyzed 84 80 74
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: mL
Total Ensovibep Number Analyzed 77 participants 78 participants 74 participants
3230
(35.0%)
3310
(37.5%)
3330
(38.7%)
Free Ensovibep Number Analyzed 84 participants 80 participants 74 participants
2760
(46.1%)
2590
(36.4%)
2470
(45.6%)
16.Secondary Outcome
Title Part B: Change From Baseline in Log10 SARS-CoV-2 Viral Load Through Day 8
Hide Description The SARS-CoV-2 viral load was measured by means of a nasopharyngeal swab, followed by quantitative reverse transcription-polymerase chain reaction assay at a central laboratory. The multiple comparison procedure-modeling methodology was used.
Time Frame Baseline (Day 1) and Days 3, 5 and 8
Hide Outcome Measure Data
Hide Analysis Population Description
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Arm/Group Title Phase 3/Part B: Ensovibep 75 mg Phase 3/Part B: Placebo
Hide Arm/Group Description:
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
Phase 3/Part B: Placebo. Part B was not initiated.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
17.Secondary Outcome
Title Part B: Time to Sustained Clinical Recovery
Hide Description

Sustained clinical recovery was defined as follows;

  1. All symptoms from the modified FDA COVID-19 questionnaire scored as moderate or severe at baseline were subsequently scored as mild or absent, and
  2. All symptoms from the modified FDA COVID-19 questionnaire scored as mild or absent at baseline were subsequently scored as absent, with no subsequent worsening, up to Day 29.
Time Frame Up to Day 29
Hide Outcome Measure Data
Hide Analysis Population Description
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Arm/Group Title Phase 3/Part B: Ensovibep 75 mg Phase 3/Part B: Placebo
Hide Arm/Group Description:
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
Phase 3/Part B: Placebo. Part B was not initiated.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
18.Secondary Outcome
Title Part B: Percentage of Participants With Treatment-Emergent Anti-Drug Antibody (ADA) Response to Ensovibep
Hide Description

Treatment-emergent ADA is defined as any participant with a

  1. 2-fold (1 dilution) increase in titer than the minimum required dilution if no ADAs were detected at baseline (treatment-induced ADA); or,
  2. 4-fold (2 dilutions) increase in titer compared with baseline if ADAs were detected at baseline (treatment-boosted ADA).
Time Frame Pre-dose on Day 1 and Days 15, 29, 61 and 91 postdose of Ensovibep
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Hide Analysis Population Description
The Part B of the study was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate.
Arm/Group Title Phase 3/Part B: Ensovibep 75 mg Phase 3/Part B: Placebo
Hide Arm/Group Description:
Phase 3/Part B: ensovibep active treatment. Part B was not initiated.
Phase 3/Part B: Placebo. Part B was not initiated.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Treatment-emergent adverse events were reported from first dose of study treatment (Day 1) until end of study treatment, up to a maximum duration of 98 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Ensovibep Total Placebo
Hide Arm/Group Description Participants received single IV infusion of ensovibep 600 mg on Day 1. Participants received single IV infusion of ensovibep 225 mg on Day 1. Participants received single IV infusion of ensovibep 75 mg on Day 1. Participants received single IV infusion of ensovibep on Day 1. Participants received single IV infusion of placebo matching with ensovibep on Day 1.
All-Cause Mortality
Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Ensovibep Total Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/98 (0.00%)   0/102 (0.00%)   0/300 (0.00%)   2/100 (2.00%) 
Hide Serious Adverse Events
Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Ensovibep Total Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   2/98 (2.04%)   1/102 (0.98%)   3/300 (1.00%)   9/100 (9.00%) 
Cardiac disorders           
Angina pectoris † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Cor pulmonale † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Gastrointestinal disorders           
Hiatus hernia † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Pancreatitis acute † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Infections and infestations           
COVID-19 † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
COVID-19 pneumonia † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  4/100 (4.00%) 
Sepsis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Septic shock † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  2/100 (2.00%) 
Renal and urinary disorders           
Acute kidney injury † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Respiratory, thoracic and mediastinal disorders           
Acute respiratory failure † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Paranasal sinus inflammation † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Pulmonary embolism † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
1
Term from vocabulary, MedDRA (24.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ensovibep 600 mg Ensovibep 225 mg Ensovibep 75 mg Ensovibep Total Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/100 (51.00%)   40/98 (40.82%)   40/102 (39.22%)   131/300 (43.67%)   53/100 (53.00%) 
Blood and lymphatic system disorders           
Anaemia † 1  0/100 (0.00%)  0/98 (0.00%)  3/102 (2.94%)  3/300 (1.00%)  0/100 (0.00%) 
Eosinophilia † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Haemorrhagic diathesis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Iron deficiency anaemia † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Leukopenia † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Lymphadenopathy † 1  2/100 (2.00%)  0/98 (0.00%)  0/102 (0.00%)  2/300 (0.67%)  0/100 (0.00%) 
Lymphocytosis † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Neutropenia † 1  3/100 (3.00%)  1/98 (1.02%)  4/102 (3.92%)  8/300 (2.67%)  1/100 (1.00%) 
Eye disorders           
Abnormal sensation in eye † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Disorder of globe † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Uveitis † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Vision blurred † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Gastrointestinal disorders           
Abdominal pain † 1  1/100 (1.00%)  0/98 (0.00%)  1/102 (0.98%)  2/300 (0.67%)  0/100 (0.00%) 
Abdominal pain upper † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  2/100 (2.00%) 
Aphthous ulcer † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Constipation † 1  1/100 (1.00%)  1/98 (1.02%)  0/102 (0.00%)  2/300 (0.67%)  0/100 (0.00%) 
Diarrhoea † 1  1/100 (1.00%)  1/98 (1.02%)  1/102 (0.98%)  3/300 (1.00%)  1/100 (1.00%) 
Dyspepsia † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Haemorrhoids † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Nausea † 1  3/100 (3.00%)  1/98 (1.02%)  0/102 (0.00%)  4/300 (1.33%)  2/100 (2.00%) 
Pancreatitis † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Vomiting † 1  3/100 (3.00%)  2/98 (2.04%)  1/102 (0.98%)  6/300 (2.00%)  1/100 (1.00%) 
General disorders           
Adverse drug reaction † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Asthenia † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Fatigue † 1  2/100 (2.00%)  0/98 (0.00%)  1/102 (0.98%)  3/300 (1.00%)  1/100 (1.00%) 
Infusion site haematoma † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  2/100 (2.00%) 
Infusion site swelling † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Non-cardiac chest pain † 1  0/100 (0.00%)  2/98 (2.04%)  1/102 (0.98%)  3/300 (1.00%)  0/100 (0.00%) 
Pain † 1  1/100 (1.00%)  1/98 (1.02%)  0/102 (0.00%)  2/300 (0.67%)  0/100 (0.00%) 
Pyrexia † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Swelling face † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Vessel puncture site haematoma † 1  0/100 (0.00%)  1/98 (1.02%)  1/102 (0.98%)  2/300 (0.67%)  0/100 (0.00%) 
Hepatobiliary disorders           
Nonalcoholic fatty liver disease † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Immune system disorders           
Allergy to chemicals † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Infections and infestations           
Bronchitis † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  1/100 (1.00%) 
COVID-19 † 1  6/100 (6.00%)  2/98 (2.04%)  1/102 (0.98%)  9/300 (3.00%)  4/100 (4.00%) 
COVID-19 pneumonia † 1  2/100 (2.00%)  2/98 (2.04%)  0/102 (0.00%)  4/300 (1.33%)  1/100 (1.00%) 
Cystitis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Eye infection bacterial † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Gastroenteritis † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Genital infection fungal † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Nasopharyngitis † 1  5/100 (5.00%)  1/98 (1.02%)  3/102 (2.94%)  9/300 (3.00%)  5/100 (5.00%) 
Oral candidiasis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Otitis media † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Pancreatitis viral † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Pharyngitis bacterial † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Pneumonia † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Pyelonephritis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Sinusitis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  2/100 (2.00%) 
Sinusitis bacterial † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Upper respiratory tract infection † 1  0/100 (0.00%)  1/98 (1.02%)  1/102 (0.98%)  2/300 (0.67%)  1/100 (1.00%) 
Urinary tract infection † 1  1/100 (1.00%)  0/98 (0.00%)  1/102 (0.98%)  2/300 (0.67%)  1/100 (1.00%) 
Injury, poisoning and procedural complications           
Bone contusion † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Fall † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Infusion related reaction † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Ligament sprain † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Post procedural complication † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Procedural pain † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Skin abrasion † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Investigations           
Activated partial thromboplastin time prolonged † 1  3/100 (3.00%)  1/98 (1.02%)  1/102 (0.98%)  5/300 (1.67%)  1/100 (1.00%) 
Alanine aminotransferase increased † 1  7/100 (7.00%)  3/98 (3.06%)  1/102 (0.98%)  11/300 (3.67%)  2/100 (2.00%) 
Amylase increased † 1  4/100 (4.00%)  1/98 (1.02%)  1/102 (0.98%)  6/300 (2.00%)  2/100 (2.00%) 
Aspartate aminotransferase increased † 1  6/100 (6.00%)  3/98 (3.06%)  1/102 (0.98%)  10/300 (3.33%)  2/100 (2.00%) 
Blood alkaline phosphatase increased † 1  1/100 (1.00%)  1/98 (1.02%)  0/102 (0.00%)  2/300 (0.67%)  0/100 (0.00%) 
Blood bilirubin increased † 1  3/100 (3.00%)  0/98 (0.00%)  1/102 (0.98%)  4/300 (1.33%)  0/100 (0.00%) 
Blood creatine phosphokinase increased † 1  3/100 (3.00%)  1/98 (1.02%)  1/102 (0.98%)  5/300 (1.67%)  1/100 (1.00%) 
Blood creatinine increased † 1  6/100 (6.00%)  4/98 (4.08%)  3/102 (2.94%)  13/300 (4.33%)  6/100 (6.00%) 
Blood glucose increased † 1  1/100 (1.00%)  0/98 (0.00%)  1/102 (0.98%)  2/300 (0.67%)  1/100 (1.00%) 
Blood lactate dehydrogenase increased † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Blood phosphorus decreased † 1  2/100 (2.00%)  0/98 (0.00%)  0/102 (0.00%)  2/300 (0.67%)  1/100 (1.00%) 
Blood pressure increased † 1  0/100 (0.00%)  1/98 (1.02%)  1/102 (0.98%)  2/300 (0.67%)  1/100 (1.00%) 
Blood sodium decreased † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Blood sodium increased † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Blood uric acid increased † 1  0/100 (0.00%)  3/98 (3.06%)  1/102 (0.98%)  4/300 (1.33%)  1/100 (1.00%) 
C-reactive protein increased † 1  1/100 (1.00%)  0/98 (0.00%)  1/102 (0.98%)  2/300 (0.67%)  0/100 (0.00%) 
Fibrin D dimer increased † 1  5/100 (5.00%)  2/98 (2.04%)  4/102 (3.92%)  11/300 (3.67%)  3/100 (3.00%) 
Gamma-glutamyltransferase increased † 1  3/100 (3.00%)  1/98 (1.02%)  3/102 (2.94%)  7/300 (2.33%)  1/100 (1.00%) 
Haematocrit decreased † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Haemoglobin decreased † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Hepatic enzyme increased † 1  2/100 (2.00%)  0/98 (0.00%)  0/102 (0.00%)  2/300 (0.67%)  2/100 (2.00%) 
International normalised ratio increased † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  2/100 (2.00%) 
Lipase increased † 1  6/100 (6.00%)  0/98 (0.00%)  3/102 (2.94%)  9/300 (3.00%)  1/100 (1.00%) 
Liver function test increased † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Monocyte count decreased † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  1/100 (1.00%) 
Monocyte count increased † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Pancreatic enzymes increased † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Platelet count increased † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Prothrombin time prolonged † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  3/100 (3.00%) 
Serum ferritin decreased † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
White blood cell count increased † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Metabolism and nutrition disorders           
Dehydration † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Diabetes mellitus † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Hyperamylasaemia † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Hyperglycaemia † 1  1/100 (1.00%)  1/98 (1.02%)  0/102 (0.00%)  2/300 (0.67%)  0/100 (0.00%) 
Hyperkalaemia † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Hyperlipasaemia † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Hyperlipidaemia † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Hypernatraemia † 1  0/100 (0.00%)  3/98 (3.06%)  0/102 (0.00%)  3/300 (1.00%)  1/100 (1.00%) 
Hypokalaemia † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Type 2 diabetes mellitus † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Musculoskeletal and connective tissue disorders           
Arthralgia † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Arthritis † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Back pain † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Myalgia † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Myositis † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Pain in extremity † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Nervous system disorders           
Dizziness † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Headache † 1  2/100 (2.00%)  2/98 (2.04%)  4/102 (3.92%)  8/300 (2.67%)  1/100 (1.00%) 
Neuropathy peripheral † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Psychiatric disorders           
Anxiety † 1  2/100 (2.00%)  0/98 (0.00%)  1/102 (0.98%)  3/300 (1.00%)  0/100 (0.00%) 
Depression † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Insomnia † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Renal and urinary disorders           
Dysuria † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Hydronephrosis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Renal pain † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Ureterolithiasis † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Reproductive system and breast disorders           
Dysmenorrhoea † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Heavy menstrual bleeding † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Menstruation irregular † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
Asthma † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Chronic obstructive pulmonary disease † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Cough † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Haemoptysis † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
Oropharyngeal pain † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Rhinitis allergic † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Throat irritation † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Skin and subcutaneous tissue disorders           
Dermatitis contact † 1  0/100 (0.00%)  1/98 (1.02%)  0/102 (0.00%)  1/300 (0.33%)  2/100 (2.00%) 
Eczema † 1  0/100 (0.00%)  0/98 (0.00%)  0/102 (0.00%)  0/300 (0.00%)  1/100 (1.00%) 
Petechiae † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Rash † 1  3/100 (3.00%)  1/98 (1.02%)  0/102 (0.00%)  4/300 (1.33%)  0/100 (0.00%) 
Rash maculo-papular † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  1/100 (1.00%) 
Rash papular † 1  0/100 (0.00%)  0/98 (0.00%)  1/102 (0.98%)  1/300 (0.33%)  0/100 (0.00%) 
Vascular disorders           
Hypertension † 1  1/100 (1.00%)  2/98 (2.04%)  2/102 (1.96%)  5/300 (1.67%)  0/100 (0.00%) 
Phlebitis superficial † 1  1/100 (1.00%)  0/98 (0.00%)  0/102 (0.00%)  1/300 (0.33%)  0/100 (0.00%) 
1
Term from vocabulary, MedDRA (24.1)
†
Indicates events were collected by systematic assessment
Part B was not initiated based on regulatory feedback indicating that with evolving treatment options, a placebo controlled design was no longer considered to be appropriate. 2 patients randomized to ensovibep 225 mg didn't receive treatment they were randomized to: 1 patient received no active drug as infusion was not prepared correctly; 1 patient received lower dose (<75 mg) as infusion was interrupted. For Safety set, these 2 were reported in placebo and ensovibep 75 mg arms, respectively.
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.
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: +1 862 778 8300
EMail: Novartis.email@Novartis.com
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT04828161    
Other Study ID Numbers: MP0420-CP302
2021-000890-10 ( EudraCT Number )
CSKO136A12201J ( Other Identifier: Novartis Pharmaceuticals )
First Submitted: March 24, 2021
First Posted: April 1, 2021
Results First Submitted: November 14, 2022
Results First Posted: January 18, 2023
Last Update Posted: January 18, 2023