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

NCT04514302 | Completed Phase 1 DMC

• 1 other identifier: TS202101
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  Baseline to days 2, 4, 7, 14 and 28

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

  At days 2, 4, 7, 14 and 28

• Time of viral activity

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

  Baseline to 28 days

Secondary Outcomes (3)

• Adverse events presented early after infusion

  Baseline to 24 hrs

• Adverse events presented later after infusion

  Day 2 until day 28

• Incidence of anti-INOSARS antibodies

  Baseline and day 28

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

INOSARS dose 1

EXPERIMENTAL

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 dose 2

EXPERIMENTAL

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 dose 3

EXPERIMENTAL

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)

Interventions

Placebo DRUG

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

Also known as: Control

Placebo

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.

Also known as: INOSARS

INOSARS dose 1; INOSARS dose 2; INOSARS dose 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TecSalud Investigación Clínica: lead
• Inosan Biopharma: collaborator

Study Sites (1)

Hospital San José, Tec de Monterrey

Monterrey, Nuevo León, 64718, Mexico

Location

Related Publications (1)

• 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.

  PMID: 32445440 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• José F Castilleja-Leal, MD

  TecSalud Investigación Clínica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 14, 2020
• Study Start: December 7, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)