Bacillus Calmette-guérin Vaccination to Prevent COVID-19
ACTIVATEII
A Randomized Clinical Trial for Enhanced Trained Immune Responses Through Bacillus Calmette-Guérin Vaccination to Prevent Infections by COVID-19: The ACTIVATE II Trial
2 other identifiers
interventional
301
1 country
15
Brief Summary
Based on findings of the interim analysis of the ACTIVATE study showing 53% decrease of the incidence of all new infections with BCG vaccination, a new trial is designed aiming to validate if BCG can protect against COVID-19 (Corona Virus Disease-19).The aim of the study is to demonstrate in a double-blind, placebo-controlled approach if vaccination of participants susceptible to COVID-19 with BCG vaccine may modulate their disease susceptibility for COVID-19. This will be validated using both clinical and immunological criteria. At the same time, a sub-study will be conducted and the mechanism of benefit from BCG vaccination by assessing its effect on vascular endothelial function and mononuclear blood cells will be studied
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 covid19
Started May 2020
Typical duration for phase_4 covid19
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 26, 2020
CompletedFirst Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 7, 2021
CompletedMay 11, 2021
May 1, 2021
11 months
June 1, 2020
May 9, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
This is set on visit 3 (90 ± 5 days from the date of visit 1). The two groups of vaccination are compared for the primary endpoints which is composite. Patients who meet any of the following will be considered to meet the primary endpoint: * Positive for the respiratory questionnaire endpoint when at least one of the following combination is met either at visit 2 and/or at visit 3: * One situation definitively related to COVID-19 * All four questions of symptoms possibly related to COVID-19 * At least two questions of symptoms possibly related to COVID-19 as well as need for admission at the emergency department of any hospital and/or need for intake of antibiotics * At least four questions of symptoms probably related to COVID-19 one of which is "need for admission at the emergency department of any hospital and/or need for intake of antibiotics" * Positive IgG or IgM antibodies against SARS-CoV-2
Visit 3 (90 +/- 5 days)
Secondary Outcomes (15)
Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 4
Visit 4 (135 +/- 5 days)
Positive respiratory questionnaire endpoint consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19 on visit 5
Visit 5 (180 +/- 5 days)
Prevalence of IgG/IgM against SARS-CoV-2
Screening Visit and Visit 3 (90 +/- 5 days)
Analysis of each of the components of the respiratory questionnaire consisted of questions concerning the appearance of symptoms possibly, probably and/or definitively related to COVID-19.
Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)
The impact of new cardiovascular events between the two study groups
Visit 2 (45 +/- 5 days), Visit 3 (90 +/- 5 days), Visit 4 (135 +/- 5 days), Visit 5 (180 +/- 5 days)
- +10 more secondary outcomes
Study Arms (2)
BCG vaccine
EXPERIMENTALOne intradermal injection of 0.1ml of BCG (BCG vaccine Moscow strain 361-1; Serum Institute of India Pvt. Ltd)
Placebo
PLACEBO COMPARATOROne intradermal injection of 0.1ml of sodium chloride 0.9%
Interventions
Patients susceptible to SARS-CoV-2 infection will be vaccinated with one intradermal injection of 0.1ml of BCG vaccine
Patients susceptible to SARS-CoV-2 infection will be vaccinated with one intradermal injection of 0.1ml of sodium chloride 0.9%
Eligibility Criteria
You may qualify if:
- Written informed consent
- Male or female
- Age more than or equal to 50 years based on the precise date of birth. Female participants are allowed on the premise that they are post-menopausal.
- History of at least one of the following:
- coronary heart disease;
- chronic obstructive pulmonary disease;
- Charlson's comorbidity index (CCI) more than 3
- Negative serum testing for immunoglobulin G and M against SARS-CoV-2
- Skin tuberculin test diameter less than 10mm
You may not qualify if:
- Deny to written informed consent
- Age less than 50 years
- Known infection by the Human Immunodeficiency Virus-1 (HIV-1)
- History of congenital immunodeficiency
- History of solid organ transplantation
- History of bone marrow transplantation
- Intake of chemotherapy the last two months
- Intake of radiotherapy the last two months
- Active hematological or solid tumor malignancy
- History of any anti-cytokine therapies
- History of oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than the last 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
General Hospital of Argolida - Nafplion Unit
Nafplion, Argos, 21100, Greece
2nd Department of Internal Medicine, University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
Department of Therapeutics, Alexandra General Hospital
Athens, 115 28, Greece
1st Department of Internal Medicine, General Hospital of Athens G. GENNIMATAS
Athens, 11527, Greece
2nd University Department of Internal Medicine, IPPOKRATEION General Hospital of Athens
Athens, 11527, Greece
3rd University Department of Internal Medicine, General Hospital of Chest Diseases of Athens I SOTIRIA
Athens, 11527, Greece
4th Department of Internal Medicine, "Attikon" University Hospital, National and Kapodistrian University of Athens, Medical School
Athens, 12462, Greece
Department of Pulmonary Medicine- General Hospital of Kerkyra
Corfu, 49100, Greece
General Hospital of Korinthos
Corinth, 20100, Greece
1st Department of Internal Medicine, General University Hospital of Ioannina
Ioannina, 45500, Greece
Department of Internal Medicine, General Hospital of Karditsa
Karditsa, 43100, Greece
Department of Internal Medicine, Patras University Hospital
Pátrai, Greece
General Hospital of Ptolemaida MPODOSAKEIO
Ptolemaida, 50200, Greece
1st Department of Internal Medicine, AHEPA University General Hospital of Thessaloniki
Thessaloniki, 54621, Greece
General Hospital of Imathia - Veria Unit
Véria, 59100, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonios Papadopoulos, MD, PhD
National Kapodistrian University of Athens, Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 4, 2020
Study Start
May 26, 2020
Primary Completion
April 28, 2021
Study Completion
May 7, 2021
Last Updated
May 11, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share