A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients

Summary

The purpose of the study is to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic participants who remain asymptomatic, i.e., who do not develop symptomatic coronavirus disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.

Timeline

Start

2021-04-28

Primary completion

2021-11-10

Completion

2021-12-27

Outcome

Missed primary endpoint

Stopped: “Study Stopped for Futility”

registry analysis (superiority test); C19-IG 20% 1 g vs Placebo; p = 0.5167; Difference in Percentage -3.6 (95% CI -14.6 to 7.4) NCT04847141 ↗

registry analysis (superiority test); C19-IG 20% 2 g vs Placebo; p = 0.8197; Difference in Percentage 1.2 (95% CI -9.6 to 12.0) NCT04847141 ↗

paper did not prevent development of symptomatic COVID-19. PMID 36936402 ↗

Publications

• Alemany A, Millat-Martinez P, Corbacho-Monne M, Suner C, Galvan-Casas C, Carrera C, Ouchi D, Prat N, Ara J, Nadal N, Riel R, Funollet B, Ojeda-Ciurana C, Balague LE, Salvador-Gonzalez B, Arcarons AF, Vidal-Alaball J, Del Cura-Gonzalez MI, Barrientos RR, Ramos-Blanes R, Bou AA, Mondou E, Torres M, Campins N, Sanz A, Tang Y, Rodriguez-Arias MA, Bassat Q, Clotet B; GC2010 STUDY GROUP; Mitja O. Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trial. EClinicalMedicine. 2023 Mar 10;57:101898. doi: 10.1016/j.eclinm.2023.101898. eCollection 2023 Mar.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	C19-IG20%	Protein / enzyme biologic	1 g	Subcutaneous
Subject	C19-IG20%	Protein / enzyme biologic	2 g	Subcutaneous

Indications