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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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ClinicalTrials.gov Identifier: NCT04514302
Recruitment Status : Recruiting
First Posted : August 14, 2020
Last Update Posted : October 27, 2021
Sponsor:
Collaborator:
Inosan Biopharma
Information provided by (Responsible Party):
Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 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
Estimated Study Start Date : October 27, 2021
Estimated Primary Completion Date : February 20, 2022
Estimated Study Completion Date : February 20, 2022

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04514302


Contacts
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Contact: Servando Cardona-Huerta, MD, Ph. D. +5218112121946 servandocardona@tec.mx
Contact: Alejandro Torres-Quintanilla, MD, MSc +528180205853 atorresq@tec.mx

Locations
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Mexico
Hospital San José Recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Contact: Servando Cardona-Huerta, MD, PhD    +5218112121946    servandocardona@tec.mx   
Contact: Sylvia de la Rosa-Pacheco, MD    +5218111832730    sylvia.delarosa@tec.mx   
Principal Investigator: José Fe Castilleja-Leal, MD         
Sponsors and Collaborators
Hospital San Jose Tec de Monterrey
Inosan Biopharma
Investigators
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Principal Investigator: José F Castilleja-Leal, MD Wellness and Prevention Center
Publications:
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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    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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