BCG to Reduce Absenteeism Among Health Care Workers During the COVID-19 Pandemic

Summary

The COVID-19 pandemic challenges available hospital capacity. Strategies to protect health care workers (HCW) are desperately needed. Bacille Calmette- Guérin (BCG) has protective non-specific effects against other infections; a plausible immunological mechanism has been identified in terms of "trained innate immunity".

The primary objective of the study is to evaluate whether BCG can reduce unplanned absenteeism due to illness among HCW during the COVID-19 pandemic. Secondary objectives are to reduce the number of HCW that are infected with COVID-19, reduce hospital admissions for HCW and to improve the capacity for clinical research.

Design: Single-blind, parallel-group placebo-controlled multi-centre block randomized trial including a total of 1050 HCW. The study sites will be the Manhiça hospital in Mozambique, Central Hospital Dr. Agostinho Neto and Central Hospital Dr. Baptista de Sousa in Cape Verde and Hospital Nacional Simão Mendes and other hospitals in the capital Bissau in Guinea-Bissau. Population: HCW (nurses/physicians/others) ≥18 years.

Intervention: Block randomization 1:1 to intradermal standard dose (0.1 ml) of BCG vaccine or placebo (saline). Endpoints: Primary: Days of unplanned absenteeism due to illness. Secondary: Days of absenteeism because of documented COVID-19; cumulative incidence of infectious disease hospitalizations.

Follow-up: mobile phone interviews every second week, regarding symptoms, absenteeism and causes, COVID-19 testing (if done) and their results.

Perspectives: If BCG can reduce HCW absenteeism it has global implications. The intervention can quickly be scaled up all over the world.

Conditions

• Covid19
• Morbidity
• Absenteeism

Interventions

BIOLOGICAL

BCG-Denmark

Participants randomized to receive BCG will receive one 0.1 ml dose of Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) by intradermal injection in the left deltoid region.

BIOLOGICAL

Saline

Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the right deltoid region.

Sponsors & Collaborators

• Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal

  collaborator UNKNOWN

• University of Cape Verde, Praia, Cape Verde

  collaborator UNKNOWN

• National Institute of Public Health of Cape Verde, Praia, Cape Verde

  collaborator UNKNOWN

• Centro de Investigacao em Saude de Manhica

  collaborator OTHER

• European and Developing Countries Clinical Trials Partnership (EDCTP)

  collaborator OTHER_GOV

• Bandim Health Project, Bissau, Guinea-Bissau

  collaborator UNKNOWN

• University of Southern Denmark

  lead OTHER

Principal Investigators

• Christine Stabell Benn, Professor · University of Southern Denmark

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-12-03

Primary Completion

2022-07-13

Completion

2022-07-13

Countries

• Guinea-Bissau
• Mozambique

Study Locations