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

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

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.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Placebo; Drug: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS)

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64718
      • Hospital San José, Tec de Monterrey

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital San Jose Tec de Monterrey
• Collaborators: Inosan Biopharma
• Investigators: Principal Investigator: José F Castilleja-Leal, MD, Hospital San Jose Tec de Monterrey

Publications and helpful links

General Publications

• Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): August 1, 2022

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 23, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Passive immunotherapy; Immunoglobulin fragments; Hyperimmune equine serum
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies; Immunoglobulins; Immunoglobulins, Intravenous
• Other Study ID Numbers: TS202101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No