| Primary | Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge | 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,
- = outpatient, with no activities limitation;
- = outpatient, with activities limitation;
- = hospitalised with no oxygen therapy required;
- = oxygen therapy employing a mask;
- = non-invasive ventilation or high flow oxygen;
- = Mechanical ventilation;
- = mechanical ventilation and organ support (vasopressors, extracorporeal membrane oxygenation (ECMO), renal replacement therapy (RRT);
- = Death
| These patients constituted the Modified intent-to-treat (mITT) population. | Posted | | Count of Participants | | Participants | | Discharge or up to Day 28 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| | | Title | Denominators | Categories |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The proportion of responders was compared using a one-tailed Z test with a continuity correction. It was established that: H0= Proportion of responders in placebo = pINM005 H1= Proportion of responders in placebo < pINM005 A critical value of alpha of 0.025 was be used. | one-tailed Z test with a continuity corr | | 0.1513 | | Risk Difference (RD) | 5.28 | | | 2-Sided | 95 | -3.95 | 14.5 | | | | | Superiority | Assuming a 70% "standard of care" event rate and an absolute effect size of 15 percentage points, for a power of 80% and an error α = 0.025 (for a one-tailed comparison), 121 subjects were required in each treatment group, totaling 242 participating subjects |
|
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Cmax) | 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
| A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. | Posted | | Median | Inter-Quartile Range | mg/L | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Clearance) | INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: - Clearance (mL/h) after Dose 1 | A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. | Posted | | Median | Inter-Quartile Range | mL/h | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance) | 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 | A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. | Posted | | Median | Inter-Quartile Range | mL/h/kg | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (AUC0) | 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
| A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. | Posted | | Median | Inter-Quartile Range | mg/L*h | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time) | 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
| A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. | Posted | | Median | Inter-Quartile Range | hs | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate) | 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
| A subgroup of 19 patients were selected for the PK substudy. Among these patients, 9 were on INM005 and 10 under placebo. | Posted | | Median | Inter-Quartile Range | hs^-1 | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Distribution Volume) | INM005 product concentration in serum at different time points after dosing. The following PK parameters were measured: - Distribution Volume (L) after Dose 1 | 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. | Posted | | Median | Inter-Quartile Range | L | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Distribution Volumen) | 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 | 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. | Posted | | Median | Inter-Quartile Range | L/Kg | | 0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| Secondary | Time to Progression of Disease | 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). | | Posted | | Mean | Standard Error | days | | 28 days | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Clinical Improvement at Day 7 and Day 14 | 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. | | Posted | | Count of Participants | | Participants | | up to 2 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Secondary | Patients Discharged at 28 Days | Rate of discharged patients at 28 days | Event rates were obtained from the Kaplan-Meier survival curves for mITT population | Posted | | Count of Participants | | Participants | | up to 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Participants Who Require (ICU) Hospitalization | Cumulative percentage of patients who require Intensive care unit (ICU) hospitalization | | Posted | | Count of Participants | | Participants | | up to 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Participants Who Require Mechanical Ventilation Assistance (MVA) | Rate of participants who require Mechanical ventilation assistance | | Posted | | Count of Participants | | Participants | | up to 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Mortality at Day 28 | Mortality rate due to complications from COVID-19 at day 28 | | Posted | | Count of Participants | | Participants | | up to 4 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Secondary | Changes in Viral Load | 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). | Data was not available for the whole sample | Posted | | Count of Participants | | Participants | | up to 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Other Pre-specified | Anti SARS-CoV-2 Antibodies Levels | Measurement of anti SARS-CoV-2 antibodies titer levels. Immunoglobulin G (IgG) at 0, 7, 21 days | All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows | Posted | | Mean | Standard Error | IgG titers | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| Other Pre-specified | Changes in Troponin T Levels | Changes in Troponin T levels will be evaluated at baseline, day 7 and day 21 as a measurement of disease progression | All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows | Posted | | Mean | Standard Deviation | ng/mL | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Other Pre-specified | Changes in D-dimer Levels | Changes in D-dimer levels will be evaluated at Baseline, day 7 and day 21 as a measurement of disease progression | All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows | Posted | | Mean | Standard Deviation | ng/mL | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Other Pre-specified | Changes in Ferritin Levels | Changes in Ferritin levels will be evaluated at baseline, day 7 and day 21 as a measurement of disease progression | All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows | Posted | | Mean | Standard Deviation | ng/mL | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Other Pre-specified | Changes in Lactate Dehydrogenase (LDH) Levels | Changes in LDH levels will be evaluated at baseline, day 2, day 4 and day 21 as a measurement of disease progression | All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows | Posted | | Mean | Standard Deviation | IU/L | | 3 weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
| |
| Other Pre-specified | Changes in C-reactive Protein Levels | Changes in C-reactive protein levels will be evaluated at baseline, day 7, and day 21 as a measurement of disease progression | All participants included in the Overall Number of Participants Analyzed are accounted for in at least one of the Rows | Posted | | Mean | Standard Deviation | mg/L | | 3 weeks | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| Other Pre-specified | Measurement of Anti-INM005 Antibodies | Measurement of anti-INM005 antibodies: baseline and 21 days | | Posted | | Count of Participants | | Participants | | 3 weeks | | | | ID | Title | Description |
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| OG000 | 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 investigational medicinal product (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. |
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