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

• Status: Completed
• Trial end date: 2020-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inmunova S.A.

Criteria

Inclusion Criteria:

1. Subjects of both sexes aged 18 to 79 years of age

2. SARS-CoV-2 infection confirmed by PCR for virus detection

3. Patients with moderate or severe disease by NIH definition, which requires hospitalization.

4. Acceptance to participate in the study by the signature of the informed consent by a subject or their relative, if applicable

5. 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

6. Female patients of child-bearing age with negative pregnancy test

Exclusion Criteria:

1. Patients who have received treatment with plasma from COVID-19 convalescents.

2. Patients who are participating in other therapeutic clinical trials

3. Patients who require mechanical respiratory assistance or are hospitalized in the ICU at the time of the screening visit.

4. 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.

5. Pregnant or breastfeeding women

6. 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

7. Patients who are expected to be referred to another institution within 72 hours of enrollment, which prevents proper follow-up of that patient.