Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19

Phase I, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Antiviral Efficacy of Three Different Single Doses of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) in Adult Patients With Mild COVID-19

This is a randomized, placebo-controlled, double-blind phase I clinical study of anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) to evaluate the safety and antiviral efficacy for the treatment of adult patients with mild COVID-19 and low risk of disease progression.

Key Inclusion criteria

• Outpatient with a RT-qPCR confirmation of SARS-CoV-2 infection
• Body Mass Index (BMI) at screening of 18.0 - 34.9 kg/m^2
• Presence of at least one symptom consistent with COVID-19
• Mild illness as defined by no requirement of supplementary oxygen or hospitalization criteria are met

Key Exclusion criteria

• Presence of a risk factor for disease progression documented for COVID-19 such as: uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary disease, COPD, asthma, active cancer, immunosuppression, hypercoagulable states, CKD currently under dialysis
• Documented allergy to equine serum proteins
• Previous hospitalization due to COVID-19
• Supplementary oxygen, invasive ventilation, or mechanical circulatory support requirements
• Having received convalescent plasma or intravenous immunoglobulins for the treatment of COVID-19
• Previous vaccination or plans to get vaccinated for COVID-19
• In the opinion of investigator, other health conditions that suppose an increased risk of progression of disease

NOTE: Other inclusion/exclusion criteria apply