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

Sponsor

Hospital San Jose Tec de Monterrey (Other)

Overall Status

Completed

CT.gov ID

NCT04514302

Collaborator

Inosan Biopharma (Industry)

Enrollment

Location

Arms

7.8

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Placebo Drug: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

ParallelParallel

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double Blind

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 7, 2021

Actual Primary Completion Date :

Aug 1, 2022

Actual Study Completion Date :

Aug 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min.	Drug: Placebo Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering. Other Names: Control
Experimental: INOSARS dose 1 Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.	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. Other Names: INOSARS
Experimental: INOSARS dose 2 Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.	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. Other Names: INOSARS
Experimental: INOSARS dose 3 Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.	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. Other Names: INOSARS

Outcome Measures

Primary Outcome Measures

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]
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

Secondary Outcome Measures

Adverse events presented early after infusion [Baseline to 24 hrs]
Number of adverse events per group presented in the first 24 hours
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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