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

• Status: Recruiting
• Trial end date: 2022-02-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital San Jose Tec de Monterrey
• Collaborator: Inosan Biopharma
• Treatments: Antibodies; Immunoglobulin Fragments; Immunoglobulins; Immunoglobulins, Intravenous

Criteria

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