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

Sponsor
University of Southern Denmark (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04641858
Collaborator
Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal (Other), University of Cape Verde, Praia, Cape Verde (Other), National Institute of Public Health of Cape Verde, Praia, Cape Verde (Other), Centro de Investigacao em Saude de Manhica (Other), European and Developing Countries Clinical Trials Partnership (EDCTP) (Other), Bandim Health Project, Bissau, Guinea-Bissau (Other)
668
Enrollment
2
Locations
2
Arms
19.9
Anticipated Duration (Months)
334
Patients Per Site
16.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: BCG-Denmark
  • Biological: Saline
 Phase 4

Detailed Description

The main hypothesis for this study is that BCG vaccination of HCW reduces unplanned absenteeism due to illness by 20%.

Trial design Single-blind, parallel-group placebo-controlled adaptive multicentre trial, with block-randomisation 1:1 (treatment:placebo) in blocks of 20 within strata defined by gender (male/female) and occupational group (doctors/ nurses/other) to an intradermal standard 0.1 ml dose of BCG vaccine or placebo (saline) including a total of 1050 HCW (BCG arm and placebo arm).

Study population:

Health Care Workers defined as a person who delivers care and services to the sick and ailing either directly as doctors and nurses or indirectly as aides, helpers, laboratory technicians, or even medical waste handlers.

Intervention:

The intervention will consist of the administration of an intradermal injection of a standard 0.1 ml adult dose of attenuated Mycobacterium bovis BCG (Bacillus Calmette-Guerin), Danish strain 1331, 2-8 × 10*5 CFU or the placebo comparator: intradermal standard 0.1 ml saline solution (NaCl 0.9%). Both BCG and saline solution will be injected in the skin over the upper deltoid muscle.

Blinding:

The BCG vaccine will be administered by study physicians/nurses, who are not blinded but also not involved in the data collection. Participants, data collectors and data entry clerks will be blinded to the treatment allocation.

In case of serious adverse events, the participant can be unblinded after consultation with the investigator or the vaccinating physician/nurse. When the study has ended, all participants will receive information about the intervention that they received.

Follow-up:

Follow-up will last for 6 months (182 days). Every second week, participants will be contacted over telephone and interviewed for symptoms and absenteeism from work. By the end of follow-up, participants will be invited for another POC test for COVID-19 serology.

Sample size:

The sample size was calculated on the basis of the primary hypothesis. A total of 1050 HCW randomized with an estimated loss to follow-up of 5%, and a mean number of days off work due to illness in the control group of 5 days (SD=5) over a 6-month period will demonstrate a reduction among BCG vaccinated of 20% for a mean absence of 4 days (80% power and alpha 0.05). The estimated loss to follow-up (5%) was based on past telephone-based surveys conducted in Mozambique and Bissau.

Study Design

Study Type:
Interventional
Actual Enrollment :
668 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Multi-center randomized placebo-controlled trialMulti-center randomized placebo-controlled trial
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participants will be blinded to treatment. The physicians administering the BCG vaccine or placebo will not be blinded. Those assessing outcomes will be blinded to the randomization allocation. In case of serious adverse events, the participant can be unblinded after consultation with the coordinating PI or sponsor.
Primary Purpose:
Prevention
Official Title:
BCG Vaccine to Reduce Unplanned Absenteeism Due to Illness of Health Care Workers During the COVID-19 Pandemic. A Multi-center Randomised Controlled Trial (BCG-COVID-RCT)
Actual Study Start Date :
Dec 3, 2020
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: BCG-Denmark

Participants that are randomized in the active arm will receive an adult 0.1 ml dose of BCG vaccine (BCG-Denmark, AJ Vaccines) in the skin covering the right upper deltoid muscle. Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units of the live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.

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.
Placebo Comparator: Control

Placebo will be 0.1 ml sterile 0.9 % NaCl, which has a similar color and appearance as the resuspended BCG vaccine.

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.

Outcome Measures

Primary Outcome Measures

  1. Days of unplanned absenteeism due to illness [6 months after inclusion]

    Unplanned absenteeism is defined by being absent from work due to causes other than holidays, parental leave, and other planned leaves, family assistance (including mourning leave) and quarantine measures.

Secondary Outcome Measures

  1. Days of unplanned absenteeism due to documented COVID-19 [6 months after inclusion]

    Unplanned absenteeism is defined by being absent from work due to causes other than holidays, parental leave, and other planned leaves, family assistance (including mourning leave) and quarantine measures.

  2. Cumulative incidence of hospital admissions due to illness (minus accidents). [6 months after inclusion]

    Hospital admissions involves staying at a hospital for at least one night or more for medical reasons. It includes admissions to hospital wards and overnight stays in emergency departments.

  3. Death [6 months after inclusion]

    Whether the participant died during follow-up

Other Outcome Measures

  1. Hospitalisation for COVID-19 [6 months after inclusion]

    Refers to the number of nights of hospitalisation due to COVID-19

  2. Hospitalisation besides COVID-19 [6 months after inclusion]

    Refers to the number of nights of hospitalisation due to other reasons besides COVID-19

  3. Time to hospitalisation [6 months after inclusion]

    Time, in days, from enrolment to first night of hospitalisation

  4. Time to absenteeism [6 months after inclusion]

    Time, in days, from enrolment to first day absent from work due to ill-health and disease

  5. Time to COVID-19 absenteeism [6 months after inclusion]

    Refers to the number of days since enrolment to first day absent from work due to suspected COVID-19

  6. COVID-19 infection [6 months after inclusion]

    Describes if the participant is positive for SARS-CoV2 or has had COVID-19

  7. Time to COVID-19 [6 months after inclusion]

    Time, in days, from enrolment to positive test for SARS-CoV2

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • health care worker (physician, nurse, or other) based at one of the research hospitals.

  • age ≥18 years

Exclusion Criteria:

  • known allergy to (components of) BCG or serious adverse events to prior BCG administration;

  • known previous, active or latent infection with Mycobacterium tuberculosis or other mycobacterial species

  • fever (>38 C) within past 24 hours;

  • previous confirmed COVID-19 (positive test - PCR or antibody);

  • suspicion of active viral or bacterial infection

  • severely immunocompromised subjects

  • self-reported HIV infection

  • self-reported pregnancy;

  • active solid or non-solid malignancy or lymphoma within the prior two years;

  • contraindications for live attenuated vaccine administration.

  • not having a mobile phone.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bandim Health Project Bissau SAB Guinea-Bissau 1004
2 Manhiça Health Research Centre Manhiça Maputo Mozambique 1929

Sponsors and Collaborators

  • University of Southern Denmark
  • Institute of Hygiene and Tropical Medicine, NOVA University, Lisbon, Portugal
  • University of Cape Verde, Praia, Cape Verde
  • National Institute of Public Health of Cape Verde, Praia, Cape Verde
  • Centro de Investigacao em Saude de Manhica
  • European and Developing Countries Clinical Trials Partnership (EDCTP)
  • Bandim Health Project, Bissau, Guinea-Bissau

Investigators

  • Principal Investigator: Christine Stabell Benn, Professor, University of Southern Denmark

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT04641858
Other Study ID Numbers:
  • BCG-COVID-RCT
First Posted:
Nov 24, 2020
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Southern Denmark
Innate immune training
Non-specific effects of BCG
Heterologous effects
Additional relevant MeSH terms:
COVID-19

Study Results

No Results Posted as of Mar 2, 2022