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Completed

NCT Number: NCT04514302

Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for 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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital San José, Tec de Monterrey

Monterrey, Nuevo León, 64718, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

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

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.

Other names: INOSARS

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

TecSalud Investigación Clínica

Other

Collaborators

  • Inosan Biopharma

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 14, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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