NCT04379336

BCG Vaccination for Healthcare Workers in COVID-19 Pandemic

Completed Phase 3 Last updated 25 January 2022

What this trial tests

Phase 3 trial testing Bacille Calmette-Guérin (BCG) in COVID-19 in 1,000 participants. Completed in 2 January 2022.

Timeline

4 May 2020

Primary endpoint
2 January 2022

2 January 2022

Quick facts

Lead sponsor	TASK Applied Science
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	1,000
Start date	4 May 2020
Primary completion	2 January 2022
Estimated completion	2 January 2022
Sites	1 location across South Africa

Drugs / interventions tested

• Bacille Calmette-Guérin (BCG) — full drug profile →
• Placebo Comparator

Conditions studied

• COVID-19 — all drugs for COVID-19 →
• Sars-CoV2 — all drugs for Sars-CoV2 →

Sponsor

TASK Applied Science — full company profile →

Who can join

18 and older, any sex, with COVID-19 or Sars-CoV2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A novel betacoronavirus, SARS-CoV-2, is spreading rapidly throughout the world. A large epidemic in South Africa may overwhelm available hospital capacity and healthcare resources which would be worsened by absenteeism of healthcare workers and other frontline staff (HCW). Strategies to prevent morbidity and mortality of HCW are desperately needed to safeguard continuous patient care. Bacillus Calmette-Guérin (BCG) is a vaccine against tuberculosis (TB), with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, with reported morbidity and mortality reductions as high as 70%. We hypothesize that a BCG vaccination may reduce the morbidity and mortality of healthcare workers during the COVID-19 outbreak in South Africa.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Interventions to support the resilience and mental health of frontline health and social care professionals during and after a disease outbreak, epidemic or pandemic: a mixed methods systematic review.
   Pollock A, Campbell P, Cheyne J, Cowie J, et al · · 2020 · cited 412× · PMID 33150970 · DOI 10.1002/14651858.cd013779
2. Coronavirus vaccine development: from SARS and MERS to COVID-19.
   Li YD, Chi WY, Su JH, Ferrall L, et al · · 2020 · cited 242× · PMID 33341119 · DOI 10.1186/s12929-020-00695-2
3. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
4. Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
   Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
5. 100 years of Bacillus Calmette-Guérin immunotherapy: from cattle to COVID-19.
   Lobo N, Brooks NA, Zlotta AR, Cirillo JD, et al · · 2021 · cited 114× · PMID 34131332 · DOI 10.1038/s41585-021-00481-1
6. Safety and efficacy of BCG re-vaccination in relation to COVID-19 morbidity in healthcare workers: A double-blind, randomised, controlled, phase 3 trial.
   Upton CM, van Wijk RC, Mockeliunas L, Simonsson USH, et al · · 2022 · cited 70× · PMID 35582122 · DOI 10.1016/j.eclinm.2022.101414
7. Progress and Pitfalls in the Quest for Effective SARS-CoV-2 (COVID-19) Vaccines.
   Flanagan KL, Best E, Crawford NW, Giles M, et al · · 2020 · cited 64× · PMID 33123165 · DOI 10.3389/fimmu.2020.579250
8. Immunobiology and immunotherapy of COVID-19: A clinically updated overview.
   Esmaeilzadeh A, Elahi R. · · 2021 · cited 59× · PMID 33022076 · DOI 10.1002/jcp.30076