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

NCT04514302 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-01-26

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Placebo

Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.

DRUG

Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)

INOSARS is a polyvalent passive immunization based on anti-SARS-CoV-2 immunoglobulin F(ab')2 fragments from hyperimmune equine serum. Inactive ingredients: water for injection, sodium chloride and less than 10% of total protein content.

Sponsors & Collaborators

  • Inosan Biopharma

    collaborator INDUSTRY

  • TecSalud Investigación Clínica

    lead OTHER

Principal Investigators

  • José F Castilleja-Leal, MD · TecSalud Investigación Clínica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2022-08-01
Completion
2022-08-01

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04514302 on ClinicalTrials.gov