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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514302
• Other study ID #: TS202101
• Status: Completed
• Phase: Phase 1
• Start date: December 7, 2021
• Est. completion date: August 1, 2022

Study information

• Verified date: January 2023
• Source: Hospital San Jose Tec de Monterrey
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Mexico	Hospital San José, Tec de Monterrey	Monterrey	Nuevo Leon

Sponsors (2)

Lead Sponsor	Collaborator
Hospital San Jose Tec de Monterrey	Inosan Biopharma

Country where clinical trial is conducted

Mexico, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples		At days 2, 4, 7, 14 and 28
Primary	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	Adverse events presented early after infusion	Number of adverse events per group presented in the first 24 hours	Baseline to 24 hrs
Secondary	Adverse events presented later after infusion	Number of adverse events per group presented 24 hours past infusion	Day 2 until day 28
Secondary	Incidence of anti-INOSARS antibodies		Baseline and day 28