Phase 3
N=243
A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04494984 ↗Enrolled (actual)
243
Serious AEs
16.9%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge — 106; 104 Participants — p=0.1513
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- INM005 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Inmunova S.A.
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge |
106; 104 | 0.1513 |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Cmax) |
86.92; NA; 102.38; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Clearance) |
123.31; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Clearance) |
1.30; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (AUC0) |
2096.5; NA; 3066.12; NA; 2984.31; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Elimination Half-time) |
36.07; NA; 58.89; NA; 42.10; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Elimination Rate) |
0.02; NA; 0.01; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Distribution Volume) |
6.97; NA | — |
| SECONDARY Pharmacokinetics (PK) Evaluation of INM005 (Weight-adjusted Distribution Volumen) |
65.50; NA | — |
| SECONDARY Time to Progression of Disease |
14.2; 16.3; 8.7; 10.2; 24.7; 23.6 | 0.05 |
| SECONDARY Clinical Improvement at Day 7 and Day 14 |
42; 34; 85; 75 | — |
| SECONDARY Patients Discharged at 28 Days |
105; 103 | 0.09 |
| SECONDARY Participants Who Require (ICU) Hospitalization |
15; 23 | 0.22 |
| SECONDARY Participants Who Require Mechanical Ventilation Assistance (MVA) |
11; 17 | 0.30 |
| SECONDARY Mortality at Day 28 |
8; 14 | 0.21 |
| SECONDARY Changes in Viral Load |
82; 87; 35; 28; 8; 16 | 0.999 |
Summary
This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV-2 receptor binding domain (RBD) to COVID-19 patients. Improvement of the clinical course 28 days after the start of treatment will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Subjects of both sexes aged 18 to 79 years of age
- SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) for virus detection
- Patients with moderate or severe disease by NIH definition, which requires hospitalization.
- Acceptance to participate in the study by the signature of the informed consent by a subject or their relative, if applicable
- Be within 10 days of the onset of symptoms at the time of the Screening visit according to a case definition from the National Ministry of Health
- Female patients of child-bearing age with negative pregnancy test
Exclusion Criteria
- Patients who have received treatment with plasma from COVID-19 convalescents.
- Patients who are participating in other therapeutic clinical trials
- Patients who require mechanical respiratory assistance or are hospitalized in the ICU at the time of the screening visit.
- History of anaphylaxis, prior administration of equine serum (por example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) or allergic reaction due to contact or exposure to horses.
- Pregnant or breastfeeding women
- Patients who, at the doctor's discretion, are likely to die within the next 30 days due to a concomitant disease other than the study disease
- Patients who are expected to be referred to another institution within 72 hours of enrollment, which prevents proper follow-up of that patient.
Data sourced from ClinicalTrials.gov (NCT04494984). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.