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

NCT04534803 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2021-06-28

No results posted yet for this study

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

Interventions

DRUG

BCG Vaccine

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

OTHER

Placebo

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

Sponsors & Collaborators

  • Texas Medical Research Associates, L.L.C.

    collaborator UNKNOWN

  • Harvard Medical School (HMS and HSDM)

    lead OTHER

Principal Investigators

  • Megan B Murray, MD, ScD · Harvard Medical School (HMS and HSDM)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-30
Primary Completion
2022-05-31
Completion
2022-07-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04534803 on ClinicalTrials.gov