CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6,828 enrolled
Drug / intervention
BCG Vaccine +1 moredrug
Likely dose
0.9%NaClfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04327206
NCT04327206Phase 3Completed
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BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial

Murdoch Childrens Research Institute·interventional·Posted Mar 31, 2020·Updated Sep 19, 2024

In Brief

A Phase 3 clinical trial evaluating BCG Vaccine and 0.9%NaCl for Coronavirus Disease 2019 (COVID-19) and 3 related conditions. Completed, enrolled 6,828 participants across 36 sites in 5 countries.

Detailed Summary

Phase III, two-group multicentre, randomised controlled trial in up to 10 078 healthcare workers to determine if BCG vaccination reduces the incidence and severity of COVID-19 during the 2020 pandemic.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronavirus Disease 2019 (COVID-19), Respiratory Illness, Corona Virus Infection, COVID-19
CountriesAustralia, Brazil, Netherlands, Spain, United Kingdom
CollaboratorsRoyal Children's Hospital, Bill and Melinda Gates Foundation

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 31, 2020
Enrollment StartMar 30, 2020
Primary CompletionNov 10, 2021
Study CompletionMay 27, 2022
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.3 years ago

Interventions

BCG Vaccinedrug

Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331. Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection

0.9%NaCldrug

0.9% Sodium Chloride Injection