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Trial - NCT04534803


Column Value
Trial registration number NCT04534803
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04534803

First author
Last imported at : June 30, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Ximena C Tovar

Contact
Last imported at : June 30, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

ximena_tovar@hms.harvard.edu

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-01

Recruitment status
Last imported at : June 30, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion: - residents of a participating ltcf - 70 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. exclusion: - 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 - currently on any anti-cytokine therapy - taking metformin treatment - suspicion of active viral or bacterial infection - plan to leave the nursing home within the next 6 months - taking part in another intervention-based trial for covid-19 - allergy to any component of the bcg vaccine or an anaphylactic or allergic reaction to a previous dose of bcg vaccination

Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Dec. 2, 2021, 11:30 p.m.
Source : ClinicalTrials.gov

Harvard Medical School (HMS and HSDM)

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

70

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : June 30, 2021, 2:30 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

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

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 3

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1", "treatment_id": 186, "treatment_name": "Bcg vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}, {"arm_notes": "1", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]