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

NCT04847141 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 465

Last updated 2022-12-05

Study results available
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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

BIOLOGICAL

C19-IG 20%

Anti-COVID-19 Immune Globulin (Human) 20%

DRUG

0.9% Sodium chloride

C19-IG 20% matching placebo

Sponsors & Collaborators

  • Grifols Therapeutics LLC

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2021-11-10
Completion
2021-12-27
FDA Drug
Yes

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04847141 on ClinicalTrials.gov