Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19
Phase 1
Completed
- Conditions
- COVID-19
- Interventions
- Registration Number
- NCT04514302
- Lead Sponsor
- Hospital San Jose Tec de Monterrey
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min. INOSARS dose 2 Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min. INOSARS dose 3 Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min. INOSARS dose 1 Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.
- Primary Outcome Measures
Name Time Method Time of viral activity 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 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 At days 2, 4, 7, 14 and 28
- Secondary Outcome Measures
Name Time Method Adverse events presented later after infusion Day 2 until day 28 Number of adverse events per group presented 24 hours past infusion
Incidence of anti-INOSARS antibodies Baseline and day 28 Adverse events presented early after infusion Baseline to 24 hrs Number of adverse events per group presented in the first 24 hours
Trial Locations
- Locations (1)
Hospital San José, Tec de Monterrey
🇲🇽Monterrey, Nuevo Leon, Mexico