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

Phase 1 Completed 32 enrolled TecSalud Investigación Clínica Inosan Biopharma · collab

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start: 2021-12-07
Primary completion: 2022-08-01
Completion: 2022-08-01

Publications

Background 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments	Protein / enzyme biologic	5 mg/kg	Intravenous
Subject	Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments	Protein / enzyme biologic	15 mg/kg	Intravenous
Subject	Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments	Protein / enzyme biologic	30 mg/kg	Intravenous

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

Summary

Timeline

Publications

Drugs

Indications