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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- COVID-19
- Sponsor
- Hospital San Jose Tec de Monterrey
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Time of viral activity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Placebo
Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min.
Intervention: Placebo
INOSARS dose 1
Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
Intervention: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)
INOSARS dose 2
Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
Intervention: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)
INOSARS dose 3
Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
Intervention: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)
Outcomes
Primary Outcomes
Time of viral activity
Time Frame: Baseline to 28 days
Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples
Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples
Time Frame: Baseline to days 2, 4, 7, 14 and 28
Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples
Time Frame: At days 2, 4, 7, 14 and 28
Secondary Outcomes
- Incidence of anti-INOSARS antibodies(Baseline and day 28)
- Adverse events presented later after infusion(Day 2 until day 28)
- Adverse events presented early after infusion(Baseline to 24 hrs)