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BCG Vaccination for Healthcare Workers in COVID-19 Pandemic

NCT04379336 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2022-01-25

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

Bacille Calmette-Guérin (BCG)

BCG vaccine will be given intradermally in the upper arm after randomization.

OTHER

Placebo Comparator

Placebo injection will be given intradermally in the upper arm after randomization.

Sponsors & Collaborators

  • TASK Applied Science

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-04
Primary Completion
2022-01-02
Completion
2022-01-02

Countries

  • South Africa

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 NCT04379336 on ClinicalTrials.gov