Table 3.
Clinical Trials of BCG fighting against COVID-19.
| Trial ID | Countries | Status | Sample size | Intervention | Primary outcome |
|---|---|---|---|---|---|
| NCT05387655 | Netherlands | Enrolling by invitation | 500 older people | Case Control, BCG and Placebo | Incidence of infectious and inflammatory disease |
| NCT04347876 | Egypt | Unknown | 100 participants 12–80 years old | Case Control (Observational) | Pneumonia severity index and need for ICU admission |
| NCT04648800 | Poland | Recruiting Phase 3 |
1000 participants, 25 years and older | Interventional clinical trial, BCG-10 vaccine and 0.9% saline | Death and life- or health-threatening condition |
| NCT04369794 | Brazil | Active, not recruiting Phase 4 |
400 participants | Dose of 0.1 mL of BCG (2 and 8 x 1.000.000 CFU) and 0.1 ml of 0.9% NaCl saline solution | 1. Clinical evolution of COVID-19, classified as mild, moderate and severe 2. SARS-CoV-2 elimination, virus detection by PCR 3.Seroconversion rate and titration, titration of anti SARS-CoV-2 IgA, IgM and IgG |
| NCT04659941 | Brazil | Active, not recruiting Phase 2 |
753 participants | Dose of 0.1 mL of BCG and 0.1 ml of 0.9% NaCl saline solution | 1. Compare the cumulative incidence of SARS-CoV-2 infection. 2. Compare the cumulative incidence of severe forms of COVID-19. 3. Assess the BCG vaccine-mediated immune response in health care workers. |
| NCT04379336 | South Africa | Complete Phase 3 |
1000 adults | BCG and 0.9% Sodium Chloride | Incidence of HCWs hospitalized due to COVID-19 per arm |
| NCT04641858 | Denmark | Active, not recruiting Phase 4 |
668 adults | BCG-Denmark and 0.9% Sodium Chloride | Days of unplanned absenteeism due to illness, 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. |
| NCT04327206 | Australia | Complete Phase 3 |
6828 adults | BCG (Danish strain 1331) and 0.9% Sodium Chloride | Symptomatic COVID-19 by 6 months Severe COVID-19 incidence over 6 months |
| NCT04461379 | Mexico | Active, not recruiting Phase 3 |
908 adults | BCG (Tokio 172 strain) and 0.9% Sodium Chloride | 1. Demonstrate COVID- 19 disease incidence among Health care workers 2. Demonstrate cumulative incidence of hospitalization for COVID-19 among Health care workers 3. Demonstrate the Incidence of specific Antibodies against SARS-CoV-2 at 3 and 6 months in health care workers 4. Hospitalization of severe disease COVID-19 5. Oxygen supplementation in severe disease COVID-19 6. Need for intubation or non-invasive ventilation for the patient 7. Critical care admission with SARS-CoV-2 8. Mortality associated to progressive pulmonary disease |
| NCT04373291 | Denmark | Complete Phase 3 |
1293 adults | BCG-Denmark and 0.9% Sodium Chloride | Number of days of unplanned absenteeism for any reason |
| NCT04648800 | Poland | Recruiting Phase 3 |
1000 adults | BCG-10 vaccine and 0.9% Sodium Chloride | Death and life- or health-threatening condition |
| NCT04537663 | Netherlands | Recruiting Phase 4 |
5200 Elderly | BCG (Danish strain) and 0.9% Sodium Chloride | The trial has an adaptive primary endpoint. Based on predefined objective and quantitative criteria the primary endpoint will be either a clinically relevant respiratory tract infection, or COVID-19 |
| NCT04384614 | Tunisia | Withdraw | N/A | Cross-sectional | 1. Differences related to epidemiological demographic characteristics 2. Biospecimen Retention: Samples With DNA |
| NCT04475302 | India | Complete Phase 3 |
2175 Elderly | BCG | Mortality due to COVID-19 disease |
| NCT04384549 | France | Unknown Phase 3 |
1120 participants | BCG vaccine (AJ Vaccine) and 0.9% Sodium Chloride | Incidence of documented COVID-19 among health care workers exposed to SARS- CoV-2 and vaccinated with BCG compared to placebo. |
| NCT04542330 | Denmark | Active, not recruiting Phase 3 |
1700 Elderly (65-110 years old) | BCG-Denmark and 0.9% Sodium Chloride | Acute infection, acute infection identified either by a doctor, antibiotics use, hospitalization or death due to infection. |
| NCT04414267 | Greece | Complete Phase 4 |
301 Participants (50 Years and older) | BCG and 0.9% Sodium Chloride | Positive for the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 3 |
| NCT04439045 | Canada | Completed Phase 3 |
122 participants | VPM1002 is a recombinant BCG (rBCG) and 0.9% Sodium Chloride | COVID-19 infection, to compare the self-reported incidence of SARS-CoV-2 infection (confirmed by positive test) following vaccination with either VPM1002 or placebo. |
| NCT04348370 | United States | Active, not recruiting Phase 4 |
1800 Participants (18 Years to 75 Years) | BCG Vaccine And Placebo Vaccine |
Incidence of COVID 19 Infection |
| NCT02081326 | United States | Active, not recruiting Phase 2 |
150 Participants (18 Years to 65 Years) | BCG and 0.9% Sodium Chloride | 1. Number of Type 1 Diabetics with COVID-19 symptomatic infections 2. Impact of COVID-19 (severity, duration of symptoms, absence from work) 3. Reported Rates of Infectious Diseases |
| NCT04826718 | Cape Verde | Enrolling by invitation | 400 Participants (18 Years and older) | Observational Questionaire Capillary blood collection Collection of peripheral venous blood |
1. Total number of days absent from work due to COVID-19 2. Unplanned Absenteeism 3. Symptomatology after infection by SARS-CoV-2 4. Presence or absence of anti-SARS-CoV-2 Acs 5. Duration of anti-SARS-CoV-2 Acs |
| NCT04387409 | Germany | Active, not recruiting Phase 3 |
59 Participants (18 Years and older) | VPM1002 is a recombinant BCG (rBCG) and 0.9% Sodium Chloride | Number of days absent from work due to respiratory disease |
| NCT04435379 | Germany | Completed Phase 3 |
2038 Participants | VPM1002 is a recombinant BCG (rBCG) and 0.9% Sodium | Number of days with severe respiratory disease at hospital and/or at home |