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

NCT ID: NCT04514302

Last Updated: 2023-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2022-08-01

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.

INOSARS dose 1

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

INOSARS dose 2

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

INOSARS dose 3

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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.

Interventions

Placebo

Placebo of saline solution of equal volume and infusion. Content of the infusion bag and tubing will be concealed with opaque covering.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Control; INOSARS

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inosan Biopharma

INDUSTRY

Sponsor Role: collaborator

TecSalud Investigación Clínica

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

José F Castilleja-Leal, MD

Role: PRINCIPAL_INVESTIGATOR

TecSalud Investigación Clínica

Locations

Hospital San José, Tec de Monterrey

Monterrey, Nuevo León, Mexico

Countries

Mexico

References

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.

Reference Type: BACKGROUND

PMID: 32445440 (View on PubMed)

Other Identifiers

TS202101

Identifier Type: -

Identifier Source: org_study_id