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

  • STATUS
    Recruiting
  • participants needed
    242
  • sponsor
    Inmunova S.A.
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Updated on 19 February 2024
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SARS
acute respiratory syndrome (sars)

Summary

This study aims to analyze the efficacy and safety of passive immunotherapy by administering an equine hyperimmune serum (INM005) against the SARS-CoV2 RBD to Covid19 patients. Improvement of the clinical course 28 days after the start of treatment will be evaluated.

Description

The pandemic caused by the new coronavirus has generated a situation unprecedented in recent history, with several million infected and hundreds of thousands of deaths. This disease is easily transmissible by air. Although a high percentage of cases present mild clinical presentation, approximately 15% of patients present moderate to severe cases and 5% require critical care, with respiratory assistance and a high risk of mortality. No effective therapies for the treatment or prevention of SARS.CoV2 have been identified yet. Preliminary evidence indicates that passive immunotherapy with convalescent plasma could alter the clinical course of this infection in a favorable manner. This strategy, even if confirmed as successful, requires voluntary donation by patients who have recovered, not all of whom are eligible as donors, since the antibody response varies in magnitude in different patients. This adaptive stage II/III study aims to analyze the efficacy and safety of passive immunotherapy by administering a purified Fab fraction of equine hyperimmune serum (INM005) generated from antigenic stimulation with the SARS-CoV2 RBD protein, with the objective of neutralizing the interaction of SARS-CoV-2 with its cellular receptor, thus preventing the multiplication of the virus. The safety of this type of equine hyperimmune sera has already been demonstrated in previous and ongoing protocols with a biologically equivalent product against the E. Coli shiga toxin to treat patients with Hemolytic Uremic Syndrome (CT-INM004-01 and CT-INM004-02). In the present study, eligible patients will with moderate to severe symptoms of COVID-19 that require hospitalization will receive two 4 mg/kg doses of INM005, two days apart, with the aim of improving the clinical course of COVID-19 28 days after the start of treatment with the study drug.

Details
Condition COVID19
Age 18-79 years
Treatment Placebo, INM005
Clinical Study IdentifierNCT04494984
SponsorInmunova S.A.
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subjects of both sexes aged 18 to 79 years of age
SARS-CoV-2 infection confirmed by 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
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