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This study evaluated the pharmacokinetics (how the body processes it), efficacy and safety of the drug INM005 compared with placebo in COVID-19 patients. Adults aged 18-79 with PCR-confirmed SARS-CoV-2 infection requiring hospitalization for moderate or severe disease were eligible. The study was conducted in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Subjects of both sexes aged 18 to 79 years of age 2. SARS-CoV-2 infection confirmed by polymerase chain reaction (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.