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

Primary Purpose

COVID-19

Status

Completed

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

Placebo

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

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, SARS-CoV-2, Immunoglobulin fragments, Hyperimmune equine serum, Passive immunotherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital San José, Tec de Monterrey

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

INOSARS dose 1

INOSARS dose 2

INOSARS dose 3

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples

Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples

Time of viral activity

Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples

Secondary Outcome Measures

Adverse events presented early after infusion

Number of adverse events per group presented in the first 24 hours

Adverse events presented later after infusion

Number of adverse events per group presented 24 hours past infusion

Incidence of anti-INOSARS antibodies

Full Information

NCT ID

NCT04514302

First Posted

August 12, 2020

Last Updated

January 23, 2023

Sponsor

Hospital San Jose Tec de Monterrey

Collaborators

Inosan Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT04514302

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

December 7, 2021 (Actual)

Primary Completion Date

August 1, 2022 (Actual)

Study Completion Date

August 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital San Jose Tec de Monterrey

Collaborators

Inosan Biopharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Parallel

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Double Blind

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

INOSARS dose 1

Arm Type

Experimental

Arm Description

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

Arm Title

INOSARS dose 2

Arm Type

Experimental

Arm Description

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

Arm Title

INOSARS dose 3

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

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

Intervention Name(s)

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

Other Intervention Name(s)

INOSARS

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Title

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

Title

Time of viral activity

Description

Number of days in which viral load remains detectable as quantified by RT-qPCR from nasopharyngeal swab samples

Time Frame

Baseline to 28 days

Secondary Outcome Measure Information:

Title

Adverse events presented early after infusion

Description

Number of adverse events per group presented in the first 24 hours

Time Frame

Baseline to 24 hrs

Title

Adverse events presented later after infusion

Description

Number of adverse events per group presented 24 hours past infusion

Time Frame

Day 2 until day 28

Title

Incidence of anti-INOSARS antibodies

Time Frame

Baseline and day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José F Castilleja-Leal, MD

Organizational Affiliation

Hospital San Jose Tec de Monterrey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital San José, Tec de Monterrey

City

Monterrey

State/Province

Nuevo Leon

ZIP/Postal Code

64718

Country

Mexico

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

32445440

Citation

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.

Results Reference

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

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