At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 243 enrolled

Drug / intervention

INM005 +1 moredrug

Likely dose

INM005 4 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04494984

NCT04494984Phase 3Completed

Compare CT.gov

A Phase 2/3, Adaptive, Randomized, Controlled, Double-blind Study to Investigate the Pharmacokinetics, Efficacy and Safety of the Hyperimmune Equine Serum (INM005) in Adult Patients With Moderate to Severe Confirmed SARS-CoV-2 Disease.

Inmunova S.A.·interventional·Posted Jul 31, 2020·Updated Apr 20, 2026

In Brief

A Phase 3 clinical trial evaluating INM005 and Placebo for COVID-19. Completed, enrolled 243 participants across 19 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsCOVID-19

CountriesArgentina

Collaborators--

Timeline

Phase 3CompletedFinished

202120222023202420252026

Enrollment StartJul 2020

First PostedJul 2020

Primary CompletionNov 2020

Study CompletionDec 2020

TodayJul 2026

First PostedJul 31, 2020

Enrollment StartJul 27, 2020

Primary CompletionNov 23, 2020

Study CompletionDec 30, 2020

TodayJul 2, 2026

Enrollment to primary: 4 monthsPosted 5.9 years ago

Interventions

INM005drug

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.

Placebodrug

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.