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

• ClinicalTrials.gov Identifier: NCT04514302
• Recruitment Status: Completed
• First Posted: August 14, 2020
• Last Update Posted: August 3, 2022
• Sponsor: Hospital San Jose Tec de Monterrey
• Collaborator: Inosan Biopharma
• Information provided by (Responsible Party): Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey

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 (Clinical Trial)
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel
• 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: December 7, 2021
• Actual Primary Completion Date: August 1, 2022
• Actual Study Completion Date: August 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 Name: 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 Name: 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 Name: 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 Name: INOSARS

Outcome Measures

Primary Outcome Measures :

1. Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples [ Time Frame: Baseline to days 2, 4, 7, 14 and 28 ]
2. Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples [ Time Frame: At days 2, 4, 7, 14 and 28 ]
3. Time of viral activity [ Time Frame: 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 :

1. Adverse events presented early after infusion [ Time Frame: Baseline to 24 hrs ]
   Number of adverse events per group presented in the first 24 hours
2. Adverse events presented later after infusion [ Time Frame: Day 2 until day 28 ]
   Number of adverse events per group presented 24 hours past infusion
3. Incidence of anti-INOSARS antibodies [ Time Frame: Baseline and day 28 ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Mexico

Hospital San José

Monterrey, Nuevo Leon, Mexico, 64718

Sponsors and Collaborators

Hospital San Jose Tec de Monterrey

Inosan Biopharma

Investigators

• Principal Investigator: José F Castilleja-Leal, MD; Wellness and Prevention Center

More Information

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, Fätkenheuer 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.

• Responsible Party: Servando Cardona-Huerta, Wellness and Prevention Director, Hospital San Jose Tec de Monterrey
• ClinicalTrials.gov Identifier: NCT04514302
• Other Study ID Numbers: TS202101
• First Posted: August 14, 2020
• Last Update Posted: August 3, 2022
• Last Verified: August 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey:

COVID-19; SARS-CoV-2; Immunoglobulin fragments; Hyperimmune equine serum; Passive immunotherapy

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; Immunologic Factors; Physiological Effects of Drugs