CompletedPhase 2/3

A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID-19.

Argentina243 participantsStarted 2020-07-27

Plain-language 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.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge

Timeframe: Discharge or up to Day 28

Trial details

NCT IDNCT04494984

SponsorInmunova S.A.

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-11-23

Results submitted2022-03-28

View on ClinicalTrials.gov More COVID-19 trials