Table 1.
Summary of randomized controlled trials of BCG vaccination and COVID-19
| Study | Location | Primary outcome | Estimated enrolment | Status | Projected end date |
|---|---|---|---|---|---|
|
Application of BCG vaccine for immune-prophylaxis among Egyptian health-care workers during the pandemic of COVID-19 |
Egypt | Incidence of COVID-19 infection | 900 | Not yet recruiting | December 2020 |
|
Efficacy of BCG vaccination in the prevention of COVID-19 via the strengthening of innate immunity in health-care workers (COVID-BCG) |
France | Incidence of documented COVID-19 among health-care workers exposed to SARS-CoV-2 and vaccinated with BCG compared with placebo | 1,120 | Recruiting | February 2021 |
|
Reducing health-care workers absenteeism in the COVID-19 pandemic through the BCG vaccine (BCG-CORONA) |
Netherlands | Number of days of health-care workers’ unplanned absenteeism for any reason | 1,500 | Active, not recruiting | April 2021 |
|
BCG vaccination for health-care workers in COVID-19 pandemic |
South Africa | Incidence of health-care workers hospitalized owing to COVID-19 | 500 | Recruiting | April 2021 |
|
Prevention of respiratory tract infection and COVID-19 through BCG vaccination in vulnerable older adults (BCG-PRIME) |
Netherlands | Incidence of clinically relevant respiratory tract infection or COVID-19 infection | 5,200 | Recruiting | April 2021 |
|
Clinical trial evaluating the effect of BCG vaccination on the incidence and severity of SARS-CoV-2 infections among health-care professionals during the COVID-19 pandemic in Poland |
Poland | Incidence of COVID-19 infections | 1,000 | Recruiting | April 2021 |
|
BCG vaccination to prevent COVID-19 (ACTIVATEII) |
Greece | Positive for the respiratory questionnaire consisting of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3 | 900 | Recruiting | May 2021 |
|
Study to assess VPM1002 in reducing health-care professionals’ absenteeism in the COVID-19 pandemic |
Germany | Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2) | 59 | Active, not recruiting | May 2021 |
|
Reducing COVID-19-related hospital admission in the elderly by BCG vaccination |
Netherlands | SARS-CoV-2 hospital admission | 2,014* | Active, not recruiting | May 2021 |
|
Study to assess VPM1002 in reducing hospital admissions and/or severe respiratory infectious diseases in the elderly in the COVID-19 pandemic |
Germany | Number of days with severe respiratory disease at hospital and/or at home | 2,038 | Active, not recruiting | September 2021 |
|
Efficacy and safety of VPM1002 in reducing SARS-CoV-2 (COVID-19) infection rate and severity (COBRA) |
Canada | Incidence of COVID-19 infection | 3,626 | Active, not recruiting | December 2021 |
|
Using BCG vaccine to protect health-care workers in the COVID-19 pandemic |
Denmark | Days of unplanned absenteeism for any reason | 1,500 | Active, not recruiting | December 2021 |
|
BCG to reduce absenteeism among health-care workers during the COVID-19 pandemic (EDCTP) |
Denmark | Days of unplanned absenteeism due to illness | 1,050 | Recruiting | March 2022 |
|
Using BCG to protect senior citizens during the COVID-19 pandemic |
Denmark | Incidence of acute infection | 1,900 | Recruiting | March 2022 |
|
Use of BCG vaccine as a preventive measure for COVID-19 in health-care workers (ProBCG) |
Brazil | Incidence of SARS-CoV-2 infection; incidence of severe forms of COVID-19 | 1,000 | Recruiting | October 2022 |
|
BCG against COVID-19 for prevention and amelioration of severity trial (BAC to the PAST) |
USA | Incidence of severe COVID-19 disease | 2,100 | Not yet recruiting | November 2022 |
|
COVID-19: BCG as therapeutic vaccine, transmission limitation and immunoglobulin enhancement (BATTLE) |
Brazil | Clinical evolution of COVID-19; SARS-CoV-2 elimination; seroconversion rate and titration (IgA, IgM, IgG) | 1,000 | Recruiting | August 2023 |
*Actually enrolled. BCG, Bacillus Calmette–Guérin.