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Trial record 1 of 1 for:    BCG | COVID | United States
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BCG Vaccine for Health Care Workers as Defense Against COVID 19 (BADAS)

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: NCT04348370
Recruitment Status : Recruiting
First Posted : April 16, 2020
Last Update Posted : May 27, 2020
Sponsor:
Collaborators:
Baylor College of Medicine
M.D. Anderson Cancer Center
Cedars-Sinai Medical Center
Harvard University
Information provided by (Responsible Party):
Texas A&M University

Brief Summary:
SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.

Condition or disease Intervention/treatment Phase
Coronavirus Coronavirus Infection Coronavirus as the Cause of Diseases Classified Elsewhere Biological: BCG Vaccine Biological: Placebo Vaccine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomized to BCG:placebo in a 1:1 ratio.
Masking: Double (Participant, Investigator)
Masking Description: Randomization will be done centrally and computer generated with stratification per hospital in random blocks of 2, 4 and 6. The BCG vaccine will be administered by research nurses. Participants and investigators will be blinded. The research nurse that administers the BCG vaccine or placebo will not be blinded. This research nurse will not be involved in the collection of outcome data.
Primary Purpose: Prevention
Official Title: Bacillus Calmette-Guerin Vaccination as Defense Against SARS-CoV-2: A Randomized Controlled Trial to Protect Health Care Workers by Enhanced Trained Immune Responses
Actual Study Start Date : April 20, 2020
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BCG Group
FDA-approved BCG Tice strain, procured from Merck, will be used. The vaccine will be reconstituted according to the package insert. In brief, a vial containing ~1x10^8 CFU of lyophilized BCG will be reconstituted in 50 mL of saline. A single dose will consist of 0.1 mL (~2x10^5 CFU) will be administered by slow intradermal injection using a 25 gauge/ 0.5 mm syringe in the deltoid area.
Biological: BCG Vaccine
BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.

Placebo Comparator: Placebo Group
A single dose will consist of 0.1 mL saline
Biological: Placebo Vaccine
Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.




Primary Outcome Measures :
  1. Incidence of COVID 19 Infection [ Time Frame: 6 months ]
    The primary outcome measure is the development of COVID19 infection. We will use the Cox proportional-hazards model to calculate hazard ratios for the development of Covid-19. This will be reported as the proportion of individuals receiving the intervention who are PCR-positive or seroconvert. defined as number of new cases during the 6 month time period


Secondary Outcome Measures :
  1. Disease Severity [ Time Frame: up to 6 months ]
    The secondary outcome measure is disease severity calculated using the Covid Severity Scale Scoring of 0 -10. A score of 10 is worse and a score of 0 is best. Disease severity score will be based on the level of care required for individuals who test positive for COVID19 as follows: non-hospital-based care; patient hospitalized but no oxygen required; hospitalized and oxygen required; patient treated in intensive care and/or on mechanical ventilation; patient died. Additional WHO criteria for severity include severe pneumonia, respiratory failure, acute respiratory distress syndrome, sepsis and septic shock.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult (≥18 years)
  • Male or female
  • Hospital personnel taking care for patients with known or suspected SARS-CoV-2 infection and providing, on average, at least 25 hours per week of direct patient care

Exclusion Criteria:

  • Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration
  • Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection.
  • Fever (>38 C) within the past 24 hours
  • Age > 75 years
  • Pregnancy or planning pregnancy within 30 days of study enrollment
  • Breastfeeding
  • Suspicion of active viral or bacterial infection
  • Any Immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) subjects with known neutropenic with less than 1500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) known severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months
  • Living with someone who is immunosuppressed or taking immunosuppressive drugs
  • Previous documented infection with COVID19
  • Active solid or non-solid malignancy or lymphoma within the prior two years
  • Direct involvement in the design or the execution of the study
  • Expected absence from work of ≥4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)
  • Not in possession of a smartphone
  • Inability to keep the vaccine site covered in the case of a draining pustule.

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): NCT04348370


Contacts
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Contact: Jeffrey D Cirillo, PhD 979 436-0343 jdcirillo@tamu.edu
Contact: Andrew DiNardo, MD 832 822-1038 Andrew.Dinardo@Bcm.edu

Locations
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United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Pablo Avalos, MD    310-248-8571    Pablo.Avalos@cshs.org   
Principal Investigator: Moshe Arditi, MD         
United States, Texas
Texas A&M Family Care Clinic Recruiting
Bryan, Texas, United States, 77802
Contact: Gabriel A Neal, MD    979-436-0431    gneal@tamu.edu   
Contact: George Udeani, PharmD    361 221-0701    udeani@tamu.edu   
Principal Investigator: Jeffrey D Cirillo, PhD         
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Andrew DiNardo, MD    832-822-1038    Andrew.Dinardo@Bcm.Edu   
Principal Investigator: Andrew DiNardo, MD         
Sub-Investigator: Anna Mandalakas, MD         
Sub-Investigator: Seth Lerner, MD         
Baylor St. Luke's Medical Center Recruiting
Houston, Texas, United States, 77030
Contact: Seth Lerner, MD    713-798-5553    slerner@bcm.edu   
Principal Investigator: Seth Lerner, MD         
Harris Health System - Ben Taub Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Andrew DiNardo, MD    832-822-1038    Andrew.Dinardo@Bcm.Edu   
Principal Investigator: Andrew DiNardo, MD         
Sub-Investigator: Anna Mandalakas, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Marisa Lozano    713-794-4397    mllozano@mdanderson.org   
Principal Investigator: Ashish Kamat, MD         
Sponsors and Collaborators
Texas A&M University
Baylor College of Medicine
M.D. Anderson Cancer Center
Cedars-Sinai Medical Center
Harvard University
Investigators
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Principal Investigator: Jeffrey D Cirillo, PhD Texas A&M University
Principal Investigator: Andrew DiNardo, MD Baylor College of Medicine
Principal Investigator: Ashish M Kamat, MD M.D. Anderson Cancer Center
Principal Investigator: Moshe Arditi, MD Cedars-Sinai Medical Center
Publications:

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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT04348370    
Other Study ID Numbers: 2020-0432F
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Texas A&M University:
BACILLUS CALMETTE-GUÉRIN VACCINATION
BCG Vaccine
Coronavirus
SARS-CoV-2
COVID19
COVID
Additional relevant MeSH terms:
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BCG Vaccine
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic