Table 2.

Characteristics of Ongoing Clinical Trials on BCG vaccine as prophylaxis for COVID-19.

Clinical Trial (Title/ID)	Status/Country	Date	Study Design	Population	Intervention	Outcomes
Reducing Health Care Workers Absenteeism in Sars-Cov-2 Pandemic Through Bacillus Calmette-Guérin Vaccination, A Randomized Controlled Trial (BCG-CORONA) ClinicalTrials.gov Identifier: NCT04328441	Recruiting/Netherlands	March 2020/October 2020	Multicentre randomized controlled trial, placebo controlled	1000 workers (nurses and physicians) at emergency rooms and wards used for management of COVID- infected patients	BCG vaccine	Primary: Number of days of unplanned absenteeism. Secondary: Incidence of documented SARS- CoV-2 infection Incidence of severe respiratory symptoms, hospital admission, intensive care admission and death from SARS-CoV-2 infection Number of days of fever, respiratory symptoms Incidence of SARS- CoV-2 antibodies
BCG Vaccination to Protect Healthcare Workers Against COVID-19 (BRACE) ClinicalTrials.gov Identifier: NCT04327206 EudraCT Number: 2020–000919-69	Recruiting/Australia	March/2020/October 2020	Multicentre, open label randomized controlled trial	4000 healthcare workers in hospital sites	BCG vaccine	Primary: Incidence of COVID-19 disease and severe COVID-19 disease Secondary: Time to first symptom and duration of symptoms of COVID- 19 Work absenteeism, Hospital admission, critical care admission, Need for oxygen therapy, mechanical ventilation Mortality, Local and systemic adverse events to BCG
Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID- 19 ClinicalTrials.gov Identifier: NCT04350931	Not yet recruiting/Egypt	April 2020/October 2020	Multicentre randomized controlled trial, placebo controlled	900 healthcare workers at emergency rooms, ICUs and wards of isolation hospitals	BCG vaccine	Primary: incidence of confirmed cases Secondary: Number of days of absenteeism Incidence of hospital admission Incidence of ICU admission Mortality
Performance Evaluation of BCG Vaccination in Healthcare Personnel to Reduce the Severity of SARS-COV-2 Infection ClinicalTrials.gov Identifier: NCT04362124	Not yet recruiting/Colombia	April 2020/June 2021	Multicentre randomized controlled trial	1000 healthcare workers directly involved in the care of COVID-19 patients	BCG vaccine	Primary: incidence of confirmed and probable COVID-19 cases Secondary: Incidence of severe COVID-19 infection Mortality Safety of BCG vaccination
BCG Vaccine for Health Care Workers as Defense Against COVID 19 (BADAS) ClinicalTrials.gov Identifier: NCT04348370	Recruiting/USA	April 2020/May 2021	Multicentre randomized controlled trial	1800 healthcare workers involved in the care of suspected and confirmed COVID-19 patients with at least 25 hours per week of direct patient care	BCG vaccine	Primary: incidence of COVID-19 infection Secondary: Disease severity (COVID −19 Severity Scale Scoring)
Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis? ClinicalTrials.gov Identifier: NCT04347876	Recruiting/Egypt	April 2020/June 2020	Observational Case-Control	100 participants: Group A: COVID-19 positive with positive tuberculin test Group B: COVID-19 positive with negative tuberculin test	None	Primary: Pneumonia severity index Need for ICU admission Secondary Outcome Measures: COVID −19 test conversion Mortality
Reducing COVID-19 Related Hospital Admission in Elderly by BCG Vaccination ClinicalTrials.gov Identifier: NCT04417335	Active, not recruiting/Netherlands	April 2020/May 2021	Interventional Randomized controlled trial	2014 participants	BCG vaccine	Primary: SARS-CoV-2 related hospital admission Secondary Outcome Measures: duration of hospital admission due to COVID-19, cumulative incidence of SARS-CoV-2 infection, self-reported acute respiratory symptoms or fever, death due to SARS-CoV-2 infection, hospital admission for any reason, cumulative incidence of Intensive Care Admission due to SARS-CoV-2 infection
COVID-19: BCG As Therapeutic Vaccine, Transmission Limitation, and Immunoglobulin Enhancement (BATTLE) ClinicalTrials.gov Identifier: NCT04369794	Not yet recruiting/Brazil	June 2020/June 2021	Interventional randomized controlled trial	1000 participants	BCG vaccine	Primary: Clinical evolution of COVID-19 SARS-CoV-2 elimination Virus detection by PCR Seroconversion rate and titration Secondary Outcome Measures: Local and systemic adverse events to BCG
BCG Vaccination for Healthcare Workers in COVID-19 Pandemic ClinicalTrials.gov Identifier: NCT04379336	Recruiting/South Africa	May 2020/April 2021	Interventional Randomized controlled trial	500 participants	BCG vaccine	Primary: Incidence of HCWs hospitalized due to COVID-19/arm. Secondary Outcome: Incidence of SARS-CoV-2 infection/arm, Incidence of upper respiratory tract infections per arm, Days of unplanned absenteeism, Incidence of hospitalization for any reason/arm, Incidence of death/arm To compare incidence of death of HCW due to COVID-19 or any reason/arm.
Using BCG Vaccine to Protect Health Care Workers in the COVID-19 Pandemic ClinicalTrials.gov Identifier: NCT04373291	Not yet recruiting/Denmark	May 2020/December 2020	Interventional randomized controlled trial	1500 participants	BCG vaccine	Primary: Number of days of unplanned absenteeism Secondary Outcome Measures: cumulative incidence of COVID-19, cumulative incidence of hospital admission, The number of days of unplanned absenteeism because of COVID-19 Cumulative incidence of Hospital Admission due to COVID-19
Efficacy of BCG Vaccination in the Prevention of COVID19 Via the Strengthening of Innate Immunity in Health Care Workers (COVID-BCG) ClinicalTrials.gov Identifier: NCT04384549	Not yet recruiting/France	May 2020/February 2021	Interventional randomized controlled trial	1120 participants	BCG vaccine	Primary:Incidence of COVID-19 among health care workers exposed to SARS CoV-2 and vaccinated with BCG compared with placebo Secondary Outcome: Numbers of COVID-19 patients requiring hospitalization in ICU and O2, artificial ventilation or extracorporeal membrane oxygenation, or deaths in BCG-vaccinated health care workers compared with placebo. Incidence of asymptomatic SARS- CoV-2 seropositive subjects among BCG-vaccinated health care workers compared with placebo
Bacillus Calmette-guérin Vaccination to Prevent COVID-19 (ACTIVATEII) ClinicalTrials.gov Identifier: NCT04414267	Recruiting/Greece	May 2020/May 2021	Interventional randomized controlled trial	900 participants	BCG vaccine	Primary Outcome Measures: Positive for the respiratory questionnaire consisted of questions concerning appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3 Secondary Outcome Measures: Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4 Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5 Prevalence of IgG/IgM against SARS-CoV-2
Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity (COBRA) ClinicalTrials.gov Identifier: NCT04439045	Not yet recruiting/Canada	June 2020/April 2021	Double-blind, randomized controlled trial	3626 front-line police officers	Recombinant BCG	Primary: COVID-19 infection Secondary: Incidence of hospitalization, ICU admission, ARDS, mechanical ventilation, secondary infection, mortality and innate trained immunity Adverse events
Study to Assess VPM1002 in Reducing Healthcare Professionals’ Absenteeism in COVID-19 Pandemic ClinicalTrials.gov Identifier: NCT04387409	Recruiting/Germany	May 2020/June 2021	Phase III, Double-blind, Randomized, Placebo-controlled Multicentre Clinical Trial	1200 healthcare professionals	Recombinant BCG	Primary: Number of days absent from work due to respiratory disease Secondary: Incidence of COVID-19 related symptoms, SARS-CoV-2 infection, mortality, ICU admission, hospital admission
Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic ClinicalTrials.gov Identifier: NCT04435379	Recruiting/Germany	June 2020/May 2021	Phase III, Randomized, Double-blind, Placebo-controlled, Multicentre, Clinical Trial	2038 adults aged 60 and above	Recombinant BCG	Primary: Number of days with severe respiratory disease Secondary: Cumulative incidence of hospital admissions, SARS-CoV-2 infection, respiratory symptoms, hospital admission, ICU admission, mortality

Notes: Adapted from Sanchez-Mostiero D, Melicor AF. Should Bacillus Calmette–Guérin (BCG) vaccine be used in the prophylaxis of COVID-19? Acta Medica Philippina. 2020;54:(Special Issue on Coronavirus Disease (COVID19)). Copyright 2020 University of the Philippines Manila. The material has been obtained with permission from the publisher of the original article.¹²⁸