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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Placebo
* Drug: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Single dose of a 150 mL saline solution administered intravenously as an infusion over 40 min. | Drug: Placebo<br>* Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.<br>* Other names: Control;|
| Experimental: INOSARS dose 1<br>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)<br>* 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.<br>* Other names: INOSARS;|
| Experimental: INOSARS dose 2<br>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)<br>* 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.<br>* Other names: INOSARS;|
| Experimental: INOSARS dose 3<br>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)<br>* 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.<br>* Other names: INOSARS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples | Baseline to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events presented early after infusion | Number of adverse events per group presented in the first 24 hours | Baseline to 24 hrs | 
| Adverse events presented later after infusion | Number of adverse events per group presented 24 hours past infusion | Day 2 until day 28 | 
| Incidence of anti-INOSARS antibodies |  | Baseline and day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, SARS-CoV-2, Immunoglobulin fragments, Hyperimmune equine serum, Passive immunotherapy