BCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST)

NCT04534803 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: IRB20-1243
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to assess the efficacy of Bacille Calmette-Guérin (BCG) vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities. The investigators hypothesize that BCG vaccination can reduce severity of Covid-19 disease. Patients who are residents of participating long-term care facilities (LTCFs), with the ability to understand and cooperate with study procedures, who agree to participate in the study will be randomly assigned to receive BCG vaccination or a placebo. Participants will be followed for up to twelve months to assess severity of Covid-19 outcomes.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.

  Number of people diagnosed with severe Covid-19 disease as documented in the electronic heath record; severe Covid-19 disease is defined as any instance of death, hospitalization, or non-hospitalization but requiring new administration of supplemental oxygen or having a decline in oxygen saturation of 10%, change from ambulant to non-ambulant for 3 or more days, or any new change in mental health status.

  12 months

Secondary Outcomes (4)

• To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of cases)

  12 months

• To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of cases), continued

  12 months

• To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of episodes)

  12 months

• To assess the efficacy of BCG vaccination compared to placebo in reducing the following among elderly residents of skilled nursing facilities (by number of days)

  12 months

Study Arms (2)

BCG Vaccine

EXPERIMENTAL

Participants randomized to the BCG arm will receive BCG vaccine. The vaccination site is about halfway down the outer aspect of the upper arm.

Drug: BCG Vaccine

Placebo Arm

PLACEBO COMPARATOR

Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm.

Other: Placebo

Interventions

BCG Vaccine DRUG

.1 mL of reconstituted BCG vaccine given intradermally at baseline.

BCG Vaccine

Placebo OTHER

.1 nL of diluent (saline) given intradermally at baseline

Placebo Arm

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Residents of a participating LTCF
• years or older
• Ability to understand and cooperate with study procedures including dressing care.
• Nursing home staff or the research team will ensure participants are correctly doing dressing care.

You may not qualify if:

• Previous or current SARS-CoV2 infection/Covid-19 disease defined by documentation of disease in clinical chart or positive PCR test.
• Previous or known active TB disease
• Does not have an established proxy or guardian, but has cognitive impairment that would prohibit the participant from fully understanding the extent of study requirements and risks, or prohibit their ability to provide informed consent.
• Obesity (Body Mass Index \[BMI\] \> 35)
• Fever (\>38 C) within the past 24 hours
• Current or historic serious underlying medical conditions:
• HIV+
• History of organ or bone marrow transplantation
• History of major immunodeficiency disorder
• Active solid or hematologic malignancy diagnosed within the past two years
• Presence of significant neurologic disease, eg. Alzheimer's disease
• Receipt of any of the following drugs:
• Currently taking immunosuppressive or immunomodulatory drugs (inhalers and/or prednisone are acceptable to take)
• The Prednisone doses equivalent \> 2 mg/kg or \> 20 mg per day of prednisone administered for \>/= 2 weeks are immunosuppressive and should be avoided with live vaccines.
• Expect to receive chemotherapy in the coming six months, receipt of chemotherapy in the past six months or undergoing chemotherapy

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• Texas Medical Research Associates, L.L.C.: collaborator

Related Publications (106)

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MeSH Terms

Conditions

COVID-19

Interventions

BCG Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tuberculosis Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Megan B Murray, MD, ScD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and investigators and designated staff whose responsibility will be to administer the BCG vaccine or placebo will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ronda Stryker and William Johnston Professor of Global Health

Model Details: Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: September 1, 2020
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: July 1, 2022
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share