A Study to Investigate the Pharmacokinetics, Efficacy and Safety of INM005 in Patients With COVID… (NCT04494984) | Clinical Trial Compass
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 range18 Years – 79 Years
SexALL
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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
✕. 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
What they're measuring
1
Number of Participants With Improvement in at Least Two Categories in WHO 8-point Ordinal Clinical Scale at Day 28 or Discharge