Covid19 Clinical Trial
Official title:
Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
NCT number | NCT04534803 |
Other study ID # | IRB20-1243 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | September 2021 |
Est. completion date | July 2022 |
Verified date | June 2021 |
Source | Harvard Medical School |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2022 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Harvard Medical School | Texas Medical Research Associates, L.L.C. |
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* Note: There are 106 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | Number of cases of any COVID-19 disease, defined as a positive SARS-Cov-2 test (per PCR or serology), plus fever (as documented in EHR) or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (as documented in EHR.) Number of cases of asymptomatic SARS-CoV-2 infection, defined as evidence of SARS-CoV-2 infection (by PCR or seroconversion), absence of associated respiratory illness (as documented in EHR), and no evidence of exposure prior to randomization (baseline serology will be negative). Number of cases of critical care admissions with SARS-CoV-2, defined as the number of admissions to critical care associated with a positive SARS-CoV-2 test. Number of cases of critical care admission duration with SARS-CoV-2, defined as the number of days admitted to critical care (using medical/hospital records) associated with a positive SARS-CoV-2 test. |
12 months | |
Secondary | 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 | 5. Number of cases of critical care admissions, defined as the number of admissions to critical care. 6. Number of cases of mechanical ventilation with SARS-CoV-2, defined as the number of participants needing mechanical ventilation (as documented by EHR) and associated with a positive SARS-CoV-2 test. 7. Number of cases of mechanical ventilation, defined as the number of participants needing mechanical ventilation. 8. Number of cases of All-Cause Mortality, defined as death reported by the long-term care facility. 9. Number of cases of any fever or respiratory illness, defined as fever (as documented in EHR), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (as documented in EHR). |
12 months | |
Secondary | 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) | Number of episodes of fever or respiratory illness, defined as fever (as documented in EHR), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (as documented in EHR). Number of episodes of any COVID-19 disease, defined as a positive SARS-Cov-2 test (per PCR or serology), plus fever (as documented in EHR) or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (as documented in EHR.) Number of episodes of local and systemic adverse events to BCG vaccination measured over the 3 months following randomization (type and severity of local and systemic adverse events will be collected and graded using toxicity grading scale). |
12 months | |
Secondary | 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) | Number of days of symptom duration of fever or respiratory illness, defined as number of days with symptoms in any episode of illness that meets the case definition for fever or respiratory illness, defined as fever (as documented in EHR), or at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure (as documented in EHR). Number of days of COVID-19 symptom duration, defined as the number of days with symptoms in any episode of illness that meets the case definition for any COVID-19 disease. |
12 months |
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