NCT04847141

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

A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Grifols Therapeutics LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• COVID-19
• Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection

Interventions

Type	Name	Description
BIOLOGICAL	C19-IG 20%	Anti-COVID-19 Immune Globulin (Human) 20%
DRUG	0.9% Sodium chloride	C19-IG 20% matching placebo

Timeline

• Start date: 2021-04-28
• Primary completion: 2021-11-10
• Completion: 2021-12-27
• First posted: 2021-04-19
• Last updated: 2022-12-05
• Results posted: 2022-12-05

Locations

12 sites across 1 country: Spain

Regulatory

• FDA-regulated drug study