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

Hospital San Jose Tec de Monterrey

Status and phase: Completed; Phase 1

Conditions: COVID-19

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04514302

TS202101

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

NOTE: Other inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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32 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min.

Treatment:

Drug: Placebo

INOSARS dose 1

Experimental group

Description:

Single dose of 5 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.

Treatment:

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

INOSARS dose 2

Experimental group

Description:

Single dose of 15 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.

Treatment:

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

INOSARS dose 3

Experimental group

Description:

Single dose of 30 mg/kg in a 150 mL saline solution administered intravenously as an infusion over 40 min.

Treatment:

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