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Using BCG Vaccine to Protect Health Care Workers in the COVID-19 Pandemic

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04373291
Recruitment Status : Not yet recruiting
First Posted : May 4, 2020
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Bandim Health Project

Brief Summary:

Background: The COVID-19 pandemic challenges the available hospital capacity, and this will be augmented by absenteeism of healthcare workers (HCW). HCW are at high risk, currently HCW constitute 20% of all the COVID-19 cases in Denmark. Strategies to prevent absenteeism of HCW are urgently needed.

Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other infections; significant reductions in morbidity and mortality have been reported, and a plausible immunological mechanism has been identified.

We hypothesize that BCG vaccination can reduce HCW absenteeism during the COVID-19 pandemic.

Primary objective: To reduce absenteeism among HCW with direct patient contacts during the COVID-19 epidemic. Secondary objective: To reduce the number of HCW that are infected with SARS-CoV-2 during the COVID-19 epidemic and to reduce the number of hospital admissions amongst HCW with direct patient contacts during the COVID-19 epidemic.

Study design: A multi-center randomized placebo controlled trial. Study population: 1500 HCW with direct patient contacts; defined as nurses, physicians and other medical staff working at emergency rooms and wards where COVID-infected patients are treated.

Intervention: Participants will be randomized 1:1 to intradermal administration of a standard dose of BCG vaccine or placebo (saline).

Main study parameters/endpoints: Primary endpoint: Number of days of (unplanned) absenteeism for any reason. Secondary endpoints: Number of days of (unplanned) absenteeism because of documented COVID infection. Cumulative incidence of hospital admissions.

Risk for participants and impact: Based on previous experience and randomized controlled trials in adult and elderly individuals, the risks of BCG vaccination are considered low. The objective of this trial is to evaluate the potential beneficial effects of BCG vaccination through a lower work absenteeism rate of HCW and/or a mitigated clinical course of COVID infection.


Condition or disease Intervention/treatment Phase
COVID-19 Non-specific Effects of Vaccines Morbidity Absenteeism Heterologous Immunity Biological: BCG-Denmark Biological: Saline Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A multi-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. In case of serious adverse events, the participant can be unblinded after consultation with the coordinating PI or sponsor.
Primary Purpose: Prevention
Official Title: Using BCG Vaccine to Enhance Non-specific Protection of Health Care Workers During the COVID-19 Pandemic. A Randomized Controlled Multi-center Trial
Estimated Study Start Date : May 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: BCG vaccine

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 left 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 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 left deltoid region.




Primary Outcome Measures :
  1. Number of days of unplanned absenteeism for any reason [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The cumulative incidence of documented COVID [ Time Frame: 6 months ]
  2. The cumulative incidence of hospital admission for any reason [ Time Frame: 6 months ]
  3. The number of days of unplanned absenteeism, because of documented COVID [ Time Frame: 6 months ]
  4. The number of days of absenteeism, because of imposed quarantine as a result of exposure to SARS-CoV-2 [ Time Frame: 6 months ]
  5. The number of days of absenteeism, because of imposed quarantine as a result of having acute respiratory symptoms, fever or documented SARS- CoV-2 infection [ Time Frame: 6 months ]
  6. The number of days of unplanned absenteeism because of self-reported acute respiratory symptoms [ Time Frame: 6 months ]
  7. The number of days of self-reported fever (≥38 °C) [ Time Frame: 6 months ]
  8. The number of days of self-reported acute respiratory symptoms [ Time Frame: 6 months ]
  9. The cumulative incidence of self-reported acute respiratory symptoms [ Time Frame: 6 months ]
  10. The cumulative incidence of death for any reason [ Time Frame: 6 months ]
  11. The cumulative incidence of death due to documented COVID [ Time Frame: 6 months ]
  12. The cumulative incidence of Intensive Care Admission for any reason [ Time Frame: 6 months ]
  13. The cumulative incidence of Intensive Care Admission due to documented COVID [ Time Frame: 6 months ]
  14. The cumulative incidence of Hospital Admission due to documented COVID [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet the following criteria:

  • Adult (≥18 years);
  • Hospital personnel caring for patients with COVID-19.

Exclusion Criteria:

  • Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
  • Known active or latent infection with Mycobacterium tuberculosis (M. tuberculosis) or other mycobacterial species
  • Previous M. tuberculosis infection
  • Previous confirmed COVID-19 infection
  • Fever (>38 C) within the past 24 hours
  • Suspicion of active viral or bacterial infection
  • Pregnancy
  • Severely immunocompromised subjects (This exclusion category comprises a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with solid organ transplantation; c) subjects with bone marrow transplantation; d) subjects under chemotherapy; e) subjects with primary immunodeficiency; f) treatment with any anti-cytokine therapies. g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months)
  • Active solid or non-solid malignancy or lymphoma within the prior two years;
  • Direct involvement in the design or the execution of the BCG-DENMARK-COVID study
  • Employed to the hospital < 22 hours per week
  • Not in possession of a smartphone/tablet.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04373291


Contacts
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Contact: Christine Stabell Benn, Professor 25883964 ext +45 cbenn@health.sdu.dk
Contact: Anne Marie Rosendahl Madsen, MD arosendahl@health.sdu.dk

Sponsors and Collaborators
Bandim Health Project
University of Southern Denmark
Investigators
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Principal Investigator: Frederik Schaltz-Buchholzer, MD Bandim Health Project, University of Southern Denmark
Principal Investigator: Anne Marie Rosendahl Madsen, MD Bandim Health Project, University of Southern Denmark
Study Chair: Christine Stabell Benn, Professor Bandim Health Project, University of Southern Denmark
Additional Information:
Publications:

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Responsible Party: Bandim Health Project
ClinicalTrials.gov Identifier: NCT04373291    
Other Study ID Numbers: BCG-DENMARK-COVID
2020-001888-90 ( EudraCT Number )
First Posted: May 4, 2020    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Non-identifiable individual data can be shared on the basis of a data sharing proposal sent to cbenn@health.sdu.dk
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: When follow-up has been completed and the dataset have been closed
Access Criteria: Non-identifiable individual data can be shared on the basis of a data sharing proposal sent to cbenn@health.sdu.dk

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No