Trial Outcomes & Findings for A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19. (NCT NCT04494984)
NCT ID: NCT04494984
Last Updated: 2026-04-20
Results Overview
The primary endpoint will be the proportion of patients who showed improvement 28 days after the administration of the first dose. A responding subject is defined as a subject with improvement in at least 2 categories on the 8-point World Health Organization (WHO) ordinal scale of clinical status or a subject who is discharged. The ordinal scale measures illness severity over time, the minimum value is 0 and the maximum value is 8. The higher is the score, the worse is the outcome. Detailed scale: 0 = no evidence of infection, 1. = outpatient, with no activities limitation; 2. = outpatient, with activities limitation; 3. = hospitalised with no oxygen therapy required; 4. = oxygen therapy employing a mask; 5. = non-invasive ventilation or high flow oxygen; 6. = Mechanical ventilation; 7. = mechanical ventilation and organ support (vasopressors, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT); 8. = Death
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
243 participants
Primary outcome timeframe
Discharge or up to Day 28
Results posted on
2026-04-20
Participant Flow
Between August 1st and October 26th, 2020, a total of 243 patients were randomized. Among these, 119 received the active treatment, and 124 received placebo which constituted the safety population. Of those, 1 patient in each group had protocol deviations, thus 118 in the INM005 and 123 participants in the placebo group constituted the mITT. The number of randomized subjects was increased to compensate for patients with protocol deviations.
Participant milestones
| Measure |
Active
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
124
|
|
Overall Study
mITT
|
118
|
123
|
|
Overall Study
COMPLETED
|
119
|
124
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The overall population was divided into moderate and severe patients
Baseline characteristics by cohort
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Total
n=241 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Female
|
38 Participants
n=118 Participants
|
46 Participants
n=123 Participants
|
84 Participants
n=241 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=118 Participants
|
0 Participants
n=123 Participants
|
0 Participants
n=241 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=118 Participants
|
92 Participants
n=123 Participants
|
188 Participants
n=241 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=118 Participants
|
31 Participants
n=123 Participants
|
53 Participants
n=241 Participants
|
|
Age, Continuous
|
54 years
n=118 Participants
|
54 years
n=123 Participants
|
54 years
n=241 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=118 Participants
|
77 Participants
n=123 Participants
|
157 Participants
n=241 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
93 Participants
n=118 Participants
|
103 Participants
n=123 Participants
|
196 Participants
n=241 Participants
|
|
Race/Ethnicity, Customized
Hispanic / Latino
|
18 Participants
n=118 Participants
|
9 Participants
n=123 Participants
|
27 Participants
n=241 Participants
|
|
Race/Ethnicity, Customized
Native american
|
6 Participants
n=118 Participants
|
9 Participants
n=123 Participants
|
15 Participants
n=241 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=118 Participants
|
2 Participants
n=123 Participants
|
3 Participants
n=241 Participants
|
|
Region of Enrollment
Argentina
|
118 participants
n=118 Participants
|
123 participants
n=123 Participants
|
241 participants
n=241 Participants
|
|
Body Mass Index
|
30.1 kg/m^2
n=118 Participants
|
30.3 kg/m^2
n=123 Participants
|
30.1 kg/m^2
n=241 Participants
|
|
Body Mass Index
Patients with BMI <30
|
58 Participants
n=118 Participants
|
59 Participants
n=123 Participants
|
117 Participants
n=241 Participants
|
|
Body Mass Index
Patients with BMI 30-35
|
27 Participants
n=118 Participants
|
38 Participants
n=123 Participants
|
65 Participants
n=241 Participants
|
|
Body Mass Index
Patients with BMI >35
|
33 Participants
n=118 Participants
|
26 Participants
n=123 Participants
|
59 Participants
n=241 Participants
|
|
Number of coexisting conditions
None
|
24 Participants
n=118 Participants
|
25 Participants
n=123 Participants
|
49 Participants
n=241 Participants
|
|
Number of coexisting conditions
One
|
39 Participants
n=118 Participants
|
39 Participants
n=123 Participants
|
78 Participants
n=241 Participants
|
|
Number of coexisting conditions
Two or more
|
55 Participants
n=118 Participants
|
59 Participants
n=123 Participants
|
114 Participants
n=241 Participants
|
|
Days from symptoms onset to study treatment
|
6 days
n=118 Participants
|
7 days
n=123 Participants
|
6 days
n=241 Participants
|
|
Score on WHO 8-point ordinal scale
|
4 units on a scale
n=118 Participants
|
4 units on a scale
n=123 Participants
|
4 units on a scale
n=241 Participants
|
|
Use of dexamethasone for COVID-19
Moderate patients · Used dexamethasone
|
31 Participants
n=74 Participants • The overall population was divided into moderate and severe patients
|
35 Participants
n=73 Participants • The overall population was divided into moderate and severe patients
|
66 Participants
n=147 Participants • The overall population was divided into moderate and severe patients
|
|
Score on WHO 8-point ordinal scale - Categorized
Hospitalized, not requiring oxygen (category 3)
|
54 Participants
n=118 Participants
|
55 Participants
n=123 Participants
|
109 Participants
n=241 Participants
|
|
Score on WHO 8-point ordinal scale - Categorized
Hospitalized, requiring supplemental oxygen (category 4)
|
61 Participants
n=118 Participants
|
64 Participants
n=123 Participants
|
125 Participants
n=241 Participants
|
|
Score on WHO 8-point ordinal scale - Categorized
Hospitalized, receiving noninvasive mechanical ventilation or high-flow oxygen devices (category 5)
|
3 Participants
n=118 Participants
|
4 Participants
n=123 Participants
|
7 Participants
n=241 Participants
|
|
COVID-19 classification by NIH
Moderate
|
74 Participants
n=118 Participants
|
73 Participants
n=123 Participants
|
147 Participants
n=241 Participants
|
|
COVID-19 classification by NIH
Severe
|
44 Participants
n=118 Participants
|
50 Participants
n=123 Participants
|
94 Participants
n=241 Participants
|
|
Use of dexamethasone for COVID-19
Moderate patients · Did not used dexamethasone
|
43 Participants
n=74 Participants • The overall population was divided into moderate and severe patients
|
38 Participants
n=73 Participants • The overall population was divided into moderate and severe patients
|
81 Participants
n=147 Participants • The overall population was divided into moderate and severe patients
|
|
Use of dexamethasone for COVID-19
Severe patients · Used dexamethasone
|
34 Participants
n=44 Participants • The overall population was divided into moderate and severe patients
|
38 Participants
n=50 Participants • The overall population was divided into moderate and severe patients
|
72 Participants
n=94 Participants • The overall population was divided into moderate and severe patients
|
|
Use of dexamethasone for COVID-19
Severe patients · Did not used dexamethasone
|
10 Participants
n=44 Participants • The overall population was divided into moderate and severe patients
|
12 Participants
n=50 Participants • The overall population was divided into moderate and severe patients
|
22 Participants
n=94 Participants • The overall population was divided into moderate and severe patients
|
PRIMARY outcome
Timeframe: Discharge or up to Day 28Population: These patients constituted the Modified intent-to-treat (mITT) population.
The primary endpoint will be the proportion of patients who showed improvement 28 days after the administration of the first dose. A responding subject is defined as a subject with improvement in at least 2 categories on the 8-point World Health Organization (WHO) ordinal scale of clinical status or a subject who is discharged. The ordinal scale measures illness severity over time, the minimum value is 0 and the maximum value is 8. The higher is the score, the worse is the outcome. Detailed scale: 0 = no evidence of infection, 1. = outpatient, with no activities limitation; 2. = outpatient, with activities limitation; 3. = hospitalised with no oxygen therapy required; 4. = oxygen therapy employing a mask; 5. = non-invasive ventilation or high flow oxygen; 6. = Mechanical ventilation; 7. = mechanical ventilation and organ support (vasopressors, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT); 8. = Death
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge
|
106 Participants
|
104 Participants
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: * Cmax after (mg/L) Dose 1 * Cmax (mg/L) after Dose 2
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Cmax)
Cmax after Dose 1
|
86.92 mg/L
Interval 72.35 to 90.4
|
NA mg/L
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (Cmax)
Cmax after Dose 2
|
102.38 mg/L
Interval 82.97 to 110.49
|
NA mg/L
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: \- Clearance (mL/h) after Dose 1
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Clearance)
|
123.31 mL/h
Interval 103.78 to 130.82
|
NA mL/h
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: \- Weight-adjusted Clearance (mL/h/kg) after Dose 1
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance)
|
1.30 mL/h/kg
Interval 1.19 to 1.37
|
NA mL/h/kg
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: * AUC0-t (mg/L\*h) after Dose 1 * AUC0-I (mg/L\*h) after Dose 1 * AUC0-I (mg/L\*h) -Normalized- after Dose 1 * AUC0-t (mg/L\*h) after Dose 2 * AUC0-I (mg/L\*h) after Dose 2 * AUC0-I (mg/L\*h) -Normalized- after Dose 2
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
AUC0-t after Dose 2
|
5965.27 mg/L*h
Interval 4436.34 to 6964.39
|
NA mg/L*h
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
AUC0-I after Dose 2
|
7906.33 mg/L*h
Interval 6926.69 to 9604.49
|
NA mg/L*h
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
AUC0-I after Dose 2 - Normalized-
|
6881.34 mg/L*h
Interval 6132.3 to 8799.64
|
NA mg/L*h
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
AUC0-I-Normalized- after Dose 1
|
2984.31 mg/L*h
Interval 2812.99 to 3546.0
|
NA mg/L*h
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
AUC0-t after Dose 1
|
2096.5 mg/L*h
Interval 1677.18 to 2117.41
|
NA mg/L*h
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (AUC0)
AUC0-I after Dose 1
|
3066.12 mg/L*h
Interval 2926.34 to 3378.91
|
NA mg/L*h
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: * Elimination half-time (hs) after Dose 1 * Elimination half-time (hs) after Dose 2 * Mean Residence Time (hs) after Dose 1
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)
Elimination half-time after Dose 1
|
36.07 hs
Interval 31.56 to 49.87
|
NA hs
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)
Elimination half-time after Dose 2
|
58.89 hs
Interval 56.14 to 67.87
|
NA hs
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time)
Mean Residence Time after Dose 1
|
42.10 hs
Interval 37.36 to 61.54
|
NA hs
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: * Elimination rate after Dose 1 * Elimination rate after Dose 2
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate)
Elimination rate after Dose 1
|
0.02 hs^-1
Interval 0.01 to 0.02
|
NA hs^-1
all data was below the lower limit of quantification
|
|
Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate)
Elimination rate after Dose 2
|
0.01 hs^-1
Interval 0.01 to 0.01
|
NA hs^-1
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. Only 6 subjects had sufficient data for the calculation of PK parameters after dose 2.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: \- Distribution Volume (L) after Dose 1
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Distribution Volume)
|
6.97 L
Interval 5.17 to 8.4
|
NA L
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dosePopulation: A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. None of the subjects on placebo showed detectable levels of the active product.
INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: \- Weight-adjusted Distribution volumen (L/kg) after Dose 1
Outcome measures
| Measure |
Active
n=9 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=10 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Distribution Volumen)
|
65.50 L/Kg
Interval 59.17 to 95.95
|
NA L/Kg
all data was below the lower limit of quantification
|
SECONDARY outcome
Timeframe: 28 daysPopulation: mITT
Time to achieve decrease in at least 2 categories on the 8-point WHO ordinal scale of clinical status. Time to discharge (days). Time to intensive care unit (ICU) discharge (days).
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Time to Progression of Disease
Time to achieve a change in at least 2 categories on the WHO scale of clinical status
|
14.2 days
Standard Error 0.7
|
16.3 days
Standard Error 0.7
|
|
Time to Progression of Disease
Time to discharge
|
8.7 days
Standard Error 0.6
|
10.2 days
Standard Error 0.7
|
|
Time to Progression of Disease
Time to intensive care unit (ICU) discharge
|
24.7 days
Standard Error 0.8
|
23.6 days
Standard Error 0.8
|
SECONDARY outcome
Timeframe: up to 2 weeksPopulation: mITT
Percentage of patients who present a decrease in at least 2 categories on the 8-point WHO ordinal scale of clinical status at 7 and 14 days after the start of the treatment.
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Clinical Improvement at Day 7 and Day 14
Day 7
|
42 Participants
|
34 Participants
|
|
Clinical Improvement at Day 7 and Day 14
Day 14
|
85 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: Event rates were obtained from the Kaplan-Meier survival curves for mITT population
Rate of discharged patients at 28 days
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Patients Discharged at 28 Days
|
105 Participants
|
103 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: mITT population
Cumulative percentage of patients who require Intensive care unit (ICU) hospitalization
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Participants Who Require (ICU) Hospitalization
|
15 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeksPopulation: mITT population
Rate of participants who require Mechanical ventilation assistance
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Participants Who Require Mechanical Ventilation Assistance (MVA)
|
11 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: up to 4 weeksMortality rate due to complications from COVID-19 at day 28
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Mortality at Day 28
|
8 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: up to 3 weeksPopulation: Data was not available for the whole sample
Percentage of participants with detectable viral load at baseline, day 7 and day 21 after the start of the treatment.. GeneFinder ™ COVID-19 PLUS RealAmp Kit was used for detection of COVID-19 virus through reverse Transcription and Real-Time Polymerase Chain Reaction from RNA extracted from Respiratory specimens such as throat swab. This product can qualitatively detect COVID-19 using One-Step Reverse Transcription Real-Time polymerase chain reaction to confirm the presence of SARS-COV-2 by amplification of the genes RdRp (RNA-dependent RNA polymerase), E (Envelope) and N (Nucleocapsid).
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Changes in Viral Load
Gene N / Day 7
|
70 Participants
|
55 Participants
|
|
Changes in Viral Load
Gene N / Day 21
|
46 Participants
|
55 Participants
|
|
Changes in Viral Load
Gene R / Baseline
|
69 Participants
|
67 Participants
|
|
Changes in Viral Load
Gene R / Day 7
|
21 Participants
|
19 Participants
|
|
Changes in Viral Load
Gene R / Day 21
|
2 Participants
|
11 Participants
|
|
Changes in Viral Load
Gene E / Baseline
|
82 Participants
|
87 Participants
|
|
Changes in Viral Load
Gene E / day 7
|
35 Participants
|
28 Participants
|
|
Changes in Viral Load
Gene E / day 21
|
8 Participants
|
16 Participants
|
|
Changes in Viral Load
Gene N / baseline
|
109 Participants
|
111 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows
Measurement of anti SARS-CoV-2 antibodies titer levels. Immunoglobulin G (IgG) at 0, 7, 21 days
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Anti SARS-CoV-2 Antibodies Levels
Baseline
|
0.124 IgG titers
Standard Error 1.408
|
0.190 IgG titers
Standard Error 1.392
|
|
Anti SARS-CoV-2 Antibodies Levels
Day 7
|
0.763 IgG titers
Standard Error 1.285
|
0.475 IgG titers
Standard Error 1.275
|
|
Anti SARS-CoV-2 Antibodies Levels
Day 21
|
2.168 IgG titers
Standard Error 1.16
|
2.027 IgG titers
Standard Error 1.157
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows
Changes in Troponin T levels will be evaluated at baseline, day 7 and day 21 as a measurement of disease progression
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Changes in Troponin T Levels
Baseline
|
0.205 ng/mL
Standard Deviation 0.053
|
0.234 ng/mL
Standard Deviation 0.284
|
|
Changes in Troponin T Levels
Day 7
|
0.208 ng/mL
Standard Deviation 0.039
|
0.219 ng/mL
Standard Deviation 0.127
|
|
Changes in Troponin T Levels
Day 21
|
0.209 ng/mL
Standard Deviation 0.061
|
0.202 ng/mL
Standard Deviation 0.014
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows
Changes in D-dimer levels will be evaluated at Baseline, day 7 and day 21 as a measurement of disease progression
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Changes in D-dimer Levels
Baseline
|
606.81 ng/mL
Standard Deviation 1043.67
|
824.82 ng/mL
Standard Deviation 1517.18
|
|
Changes in D-dimer Levels
Day 7
|
931.96 ng/mL
Standard Deviation 1495.96
|
1313.01 ng/mL
Standard Deviation 1981.13
|
|
Changes in D-dimer Levels
Day 21
|
661.10 ng/mL
Standard Deviation 1271.24
|
1049.08 ng/mL
Standard Deviation 1690.81
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows
Changes in Ferritin levels will be evaluated at baseline, day 7 and day 21 as a measurement of disease progression
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Changes in Ferritin Levels
Baseline
|
705.33 ng/mL
Standard Deviation 540.67
|
787.31 ng/mL
Standard Deviation 537.18
|
|
Changes in Ferritin Levels
Day 7
|
783.59 ng/mL
Standard Deviation 559.37
|
874.58 ng/mL
Standard Deviation 487.48
|
|
Changes in Ferritin Levels
Day 21
|
369.79 ng/mL
Standard Deviation 359.51
|
496.14 ng/mL
Standard Deviation 378.80
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows
Changes in LDH levels will be evaluated at baseline, day 2, day 4 and day 21 as a measurement of disease progression
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Changes in Lactate Dehydrogenase (LDH) Levels
Baseline
|
263.68 IU/L
Standard Deviation 136.48
|
287.96 IU/L
Standard Deviation 141.18
|
|
Changes in Lactate Dehydrogenase (LDH) Levels
Day 2 (post Dose 1)
|
263.66 IU/L
Standard Deviation 140.82
|
287.88 IU/L
Standard Deviation 154.17
|
|
Changes in Lactate Dehydrogenase (LDH) Levels
Day 4 (post Dose 2)
|
256.18 IU/L
Standard Deviation 111.44
|
315.25 IU/L
Standard Deviation 277.46
|
|
Changes in Lactate Dehydrogenase (LDH) Levels
Day 21
|
186.83 IU/L
Standard Deviation 72.90
|
207.30 IU/L
Standard Deviation 98.22
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows
Changes in C-reactive protein levels will be evaluated at baseline, day 7, and day 21 as a measurement of disease progression
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=123 Participants
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Changes in C-reactive Protein Levels
Baseline
|
53.46 mg/L
Standard Deviation 38.29
|
56.51 mg/L
Standard Deviation 36.15
|
|
Changes in C-reactive Protein Levels
Day 7
|
33.57 mg/L
Standard Deviation 35.22
|
37.18 mg/L
Standard Deviation 36.28
|
|
Changes in C-reactive Protein Levels
Day 21
|
17.34 mg/L
Standard Deviation 26.19
|
18.03 mg/L
Standard Deviation 28.19
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 weeksPopulation: mITT
Measurement of anti-INM005 antibodies: baseline and 21 days
Outcome measures
| Measure |
Active
n=118 Participants
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Measurement of Anti-INM005 Antibodies
Day 1 · Non reactive
|
111 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 1 · Low reactivity
|
5 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 1 · Medium reactivity
|
0 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 1 · High reactivity
|
0 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 1 · Missing data
|
2 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 1 · Death
|
0 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 21 · Non reactive
|
46 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 21 · Low reactivity
|
33 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 21 · Medium reactivity
|
17 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 21 · High reactivity
|
12 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 21 · Missing data
|
3 Participants
|
—
|
|
Measurement of Anti-INM005 Antibodies
Day 21 · Death
|
7 Participants
|
—
|
Adverse Events
Active
Serious events: 16 serious events
Other events: 22 other events
Deaths: 11 deaths
Placebo
Serious events: 25 serious events
Other events: 24 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
Active
n=119 participants at risk
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=124 participants at risk
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Hospital-acquired pneumonia
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
1.7%
2/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Pneumotorax
|
1.7%
2/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonar embolism
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.84%
1/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Ventilator-associated pneumonia
|
2.5%
3/119 • 28 days
Standard definitions were used
|
2.4%
3/124 • 28 days
Standard definitions were used
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Blood and lymphatic system disorders
Anemia
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Cardiac disorders
Sinus Bradycardia
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Gastrointestinal disorders
Esophagical spams
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
General disorders
Multiorganic failure
|
2.5%
3/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Infections and infestations
Bacterial ventilator-associated pneumonia
|
0.84%
1/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Infections and infestations
Bacteriemia
|
0.00%
0/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Infections and infestations
Catheter bacteriemia
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Infections and infestations
Pseudomembranous cholitis
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Infections and infestations
Sepsis
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Infections and infestations
Septic shock
|
2.5%
3/119 • 28 days
Standard definitions were used
|
2.4%
3/124 • 28 days
Standard definitions were used
|
|
Investigations
Elevated levels of hepatic enzymes
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Musculoskeletal and connective tissue disorders
Pain in Legs
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral metastasis
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Nervous system disorders
Cognitive deterioration
|
0.84%
1/119 • 28 days
Standard definitions were used
|
0.00%
0/124 • 28 days
Standard definitions were used
|
|
Nervous system disorders
Ischemic stroke
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
|
Renal and urinary disorders
Acute Renal Failure
|
0.84%
1/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/119 • 28 days
Standard definitions were used
|
0.81%
1/124 • 28 days
Standard definitions were used
|
Other adverse events
| Measure |
Active
n=119 participants at risk
Subjects will receive a 1st intravenous dose of 4 mg/kg INM005 (Anti-SARS-CoV-2 hyperimmune equine immunoglobulin F\[ab'\]2 fragments) and a 2nd intravenous dose of 4 mg/kg of INM005. Each dose will be separated by 48 h (± 2 h).
INM005: The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
Placebo
n=124 participants at risk
Subjects will receive a 1st intravenous dose of Placebo and a 2nd intravenous dose of Placebo. Each dose will be separated by 48 h (± 2 h).
Placebo: Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.5%
3/119 • 28 days
Standard definitions were used
|
4.8%
6/124 • 28 days
Standard definitions were used
|
|
Vascular disorders
High Blood Pressure
|
2.5%
3/119 • Number of events 4 • 28 days
Standard definitions were used
|
6.5%
8/124 • 28 days
Standard definitions were used
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.2%
5/119 • 28 days
Standard definitions were used
|
5.6%
7/124 • 28 days
Standard definitions were used
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.5%
3/119 • 28 days
Standard definitions were used
|
4.0%
5/124 • 28 days
Standard definitions were used
|
|
Nervous system disorders
Headache
|
1.7%
2/119 • 28 days
Standard definitions were used
|
3.2%
4/124 • 28 days
Standard definitions were used
|
|
Vascular disorders
Low blood pressure
|
1.7%
2/119 • Number of events 2 • 28 days
Standard definitions were used
|
1.6%
2/124 • Number of events 4 • 28 days
Standard definitions were used
|
|
Vascular disorders
Phlebitis
|
3.4%
4/119 • 28 days
Standard definitions were used
|
1.6%
2/124 • 28 days
Standard definitions were used
|
|
Metabolism and nutrition disorders
Hypernatremia
|
1.7%
2/119 • 28 days
Standard definitions were used
|
2.4%
3/124 • 28 days
Standard definitions were used
|
|
Investigations
Hypertranssaminemia
|
8.4%
10/119 • 28 days
Standard definitions were used
|
5.6%
7/124 • 28 days
Standard definitions were used
|
Additional Information
Fernando Goldbaum, Ph.D- Scientific Director
Inmunova
Phone: +54 9 11 3180-7011
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Principal Investigator may only publish or disseminate the results of the study exclusively for academic purposes, in relation to their own patient population once such data has been duly reviewed, observed and approved by Sponsor in advance. He/She also agrees to remove any Information from the proposed publication that is confidential that could impair obtaining adequate protection of the rights of intellectual property and / or that could reasonably harm the interests of the Sponsor.
- Publication restrictions are in place
Restriction type: OTHER