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: Drug: Placebo; Drug: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)

• 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

Study Timeline

• Study First Submitted: 2020-08-12
• Study First Submitted QC: 2020-08-13
• Study First Posted: 2020-08-14
• Study Start: 2021-12-07
• Primary Completion: 2022-08-01
• Study Completion: 2022-08-01
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-23
• Last Update Posted: 2023-01-26

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