Covid19Phase 3NCT04534803
BCG Against Covid-19 for Prevention and Amelioration of Severity Trial (BAC to the PAST)
A Phase 3 study testing BCG Vaccine in people with Covid19, run by Harvard Medical School (HMS and HSDM).
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- BCG Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jul 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 21Show fewer
- 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
About this study
Official title: Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
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.
Read the detailed description
This is a Phase III, double-blind, randomized placebo-controlled trial comparing efficacy of BCG vaccination to that of placebo in reducing severity of Covid-19. Participants will need to meet eligibility criteria in order to be included in the study. Those selected, will be asked to provide a blood or saliva sample for Covid-19 serological test and an Interferon gamma release assay (IGRA) test for tuberculosis infection, only if IGRA or tuberculin skin test (TST) result is not available from the previous year. Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo at baseline. During follow-up, the study team will extract participants information from nursing home records regarding Covid-19-like symptoms, diagnosis, outcomes, as well as any adverse side effects of BCG vaccination. At 6 and 12 months of follow up, an additional blood or saliva sample will be collected to perform a Covid-19 serological test.
The investigators will screen 2,500 individuals to enroll 2,100 participants, resulting in 1,050 receiving BCG vaccine and 1,050 receiving placebo. The proposed enrollment sample size is designed to provide 80% power to detect 60% vaccine efficacy (a relative risk of 0.4 among the vaccinated) with 0.05 type-1 error in a two-tailed test, assuming a Covid-19 attack rate of 10% in elderly NH and 38.5% severe Covid-19 among the infected patients, and a design effect = 1.2, and 15% lost during the 6-month follow-up. The number of individuals screened assumes about 20% will not be eligible/agree to be enrolled.
Note that the 60% vaccine efficacy was based on the observed three-fold decline in respiratory infections in the adolescent cohort.
Objective: To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.
Primary Endpoint 1: Cases of Covid-19 disease classified as severe. Severe COVID-19 disease will be defined as: COVID-19 disease with hospitalization, death, or non-hospitalized severe disease where non-hospitalized severe disease is defined as a change in status including administration of new supplemental oxygen or decline in oxygen saturation of 10%; change from ambulant to non-ambulant status of 3+ days; new change in mental status as documented in the electronic health record
The investigators will use the Cox proportional-hazards model to calculate hazard ratios for the development of severe Covid-19 between the BCG and placebo arms.
If BCG vaccine is shown to be effective in this age group, it will be of major benefit to both study participants and other elderly individuals at risk for infection and disease from Covid-19. With no other vaccine alternative currently available, an efficacy of even 50% could reduce the death rate among infected patients accordingly. BCG has been reported to have a variety of other possible benefits including reduction in the risk of TB disease, Alzheimer's Disease and reduction in other respiratory infection. Because these benefits have not been proven in clinical trials, they will not be presented to potential participants.
- Conditions
- Covid19
- Being tested
- BCG Vaccine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG VaccineDrug
.1 mL of reconstituted BCG vaccine given intradermally at baseline.
PlaceboOther
.1 nL of diluent (saline) given intradermally at baseline
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
- 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.
Measured: 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
- Number of cases of critical care admissions, defined as the number of admissions to critical care.
- 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.
- Number of cases of mechanical ventilation, defined as the number of participants needing mechanical ventilation.
- Number of cases of All-Cause Mortality, defined as death reported by the long-term care facility.
- 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).
Measured: 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)
- 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).
Measured: 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)
- 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study startSep 2021 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Why it stopped: At this time it has been decided by the study team the the study will no longer take place in the United States.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (106)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Medical Research Associates, L.L.C.
- Responsible party
- Principal investigator, Megan Murray, MD, ScD, Harvard Medical School (HMS and HSDM)
- Investigators
- Megan B Murray, MD, ScD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534803
- Sponsor's protocol ID
- IRB20-1243
- Status last verified
- Jun 2021
- First submitted
- 21 Aug 2020
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
PubMed 32031570Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
PubMed 32167524Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, Ma K, Xu D, Yu H, Wang H, Wang T, Guo W, Chen J, Ding C, Zhang X, Huang J, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 26;368:m1091. doi: 10.1136/bmj.m1091.
PubMed 32217556Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
PubMed 32191259Cao J, Tu WJ, Cheng W, Yu L, Liu YK, Hu X, Liu Q. Clinical Features and Short-term Outcomes of 102 Patients with Coronavirus Disease 2019 in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):748-755. doi: 10.1093/cid/ciaa243.
PubMed 32239127Basu-Ray I, Almaddah NK, Vaqar S, Soos MP. Cardiac Manifestations of Coronavirus (COVID-19). 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556152/
PubMed 32310612Danzi GB, Loffi M, Galeazzi G, Gherbesi E. Acute pulmonary embolism and COVID-19 pneumonia: a random association? Eur Heart J. 2020 May 14;41(19):1858. doi: 10.1093/eurheartj/ehaa254. No abstract available.
PubMed 32227120Zhang Y, Xiao M, Zhang S, Xia P, Cao W, Jiang W, Chen H, Ding X, Zhao H, Zhang H, Wang C, Zhao J, Sun X, Tian R, Wu W, Wu D, Ma J, Chen Y, Zhang D, Xie J, Yan X, Zhou X, Liu Z, Wang J, Du B, Qin Y, Gao P, Qin X, Xu Y, Zhang W, Li T, Zhang F, Zhao Y, Li Y, Zhang S. Coagulopathy and Antiphospholipid Antibodies in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):e38. doi: 10.1056/NEJMc2007575. Epub 2020 Apr 8.
PubMed 32268022Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.
PubMed 32291094Alunno A, Carubbi F, Rodriguez-Carrio J. Storm, typhoon, cyclone or hurricane in patients with COVID-19? Beware of the same storm that has a different origin. RMD Open. 2020 May;6(1):e001295. doi: 10.1136/rmdopen-2020-001295.
PubMed 32423970Salehi S, Abedi A, Balakrishnan S, Gholamrezanezhad A. Coronavirus Disease 2019 (COVID-19): A Systematic Review of Imaging Findings in 919 Patients. AJR Am J Roentgenol. 2020 Jul;215(1):87-93. doi: 10.2214/AJR.20.23034. Epub 2020 Mar 14.
PubMed 32174129Stam HJ, Stucki G, Bickenbach J; European Academy of Rehabilitation Medicine. Covid-19 and Post Intensive Care Syndrome: A Call for Action. J Rehabil Med. 2020 Apr 15;52(4):jrm00044. doi: 10.2340/16501977-2677.
PubMed 32286675Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available.
PubMed 32203977Richardson S, Hirsch JS, Narasimhan M, Crawford JM, McGinn T, Davidson KW; the Northwell COVID-19 Research Consortium; Barnaby DP, Becker LB, Chelico JD, Cohen SL, Cookingham J, Coppa K, Diefenbach MA, Dominello AJ, Duer-Hefele J, Falzon L, Gitlin J, Hajizadeh N, Harvin TG, Hirschwerk DA, Kim EJ, Kozel ZM, Marrast LM, Mogavero JN, Osorio GA, Qiu M, Zanos TP. Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area. JAMA. 2020 May 26;323(20):2052-2059. doi: 10.1001/jama.2020.6775.
PubMed 32320003Collaborative, T.O. OpenSAFELY: factors associated with COVID-19-related hospital death in the linked electronic health records of 17 million adult NHS patients. medRxiv, 2020.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacillus Calmette-Guerin Against Covid-19 for Prevention and Amelioration of Severity Trial
- ClinicalTrials.gov ID
- NCT04534803
- Acronym / sponsor ID
- IRB20-1243
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: At this time it has been decided by the study team the the study will no longer take place in the United States.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Texas Medical Research Associates, L.L.C.
- Study start
- Sep 2021 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a Phase III, double-blind, randomized placebo-controlled trial comparing efficacy of BCG vaccination to that of placebo in reducing severity of Covid-19. Participants will need to meet eligibility criteria in order to be included in the study. Those selected, will be asked to provide a blood or saliva sample for Covid-19 serological test and an Interferon gamma release assay (IGRA) test for tuberculosis infection, only if IGRA or tuberculin skin test (TST) result is not available from the previous year. Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo at baseline. During follow-up, the study team will extract participants information from nursing home records regarding Covid-19-like symptoms, diagnosis, outcomes, as well as any adverse side effects of BCG vaccination. At 6 and 12 months of follow up, an additional blood or saliva sample will be collected to perform a Covid-19 serological test.
The investigators will screen 2,500 individuals to enroll 2,100 participants, resulting in 1,050 receiving BCG vaccine and 1,050 receiving placebo. The proposed enrollment sample size is designed to provide 80% power to detect 60% vaccine efficacy (a relative risk of 0.4 among the vaccinated) with 0.05 type-1 error in a two-tailed test, assuming a Covid-19 attack rate of 10% in elderly NH and 38.5% severe Covid-19 among the infected patients, and a design effect = 1.2, and 15% lost during the 6-month follow-up. The number of individuals screened assumes about 20% will not be eligible/agree to be enrolled.
Note that the 60% vaccine efficacy was based on the observed three-fold decline in respiratory infections in the adolescent cohort.
Objective: To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.
Primary Endpoint 1: Cases of Covid-19 disease classified as severe. Severe COVID-19 disease will be defined as: COVID-19 disease with hospitalization, death, or non-hospitalized severe disease where non-hospitalized severe disease is defined as a change in status including administration of new supplemental oxygen or decline in oxygen saturation of 10%; change from ambulant to non-ambulant status of 3+ days; new change in mental status as documented in the electronic health record
The investigators will use the Cox proportional-hazards model to calculate hazard ratios for the development of severe Covid-19 between the BCG and placebo arms.
If BCG vaccine is shown to be effective in this age group, it will be of major benefit to both study participants and other elderly individuals at risk for infection and disease from Covid-19. With no other vaccine alternative currently available, an efficacy of even 50% could reduce the death rate among infected patients accordingly. BCG has been reported to have a variety of other possible benefits including reduction in the risk of TB disease, Alzheimer's Disease and reduction in other respiratory infection. Because these benefits have not been proven in clinical trials, they will not be presented to potential participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 allocation to receive intradermal administration of BCG vaccination or placebo.
| Arm | Type | Receives |
|---|---|---|
| BCG Vaccine | Experimental | Drug: BCG VaccineParticipants randomized to the BCG arm will receive BCG vaccine. The vaccination site is about halfway down the outer aspect of the upper arm. |
| Placebo Arm | Placebo comparator | Other: PlaceboPlacebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Residents of a participating LTCF
- 70 years or older
- Ability to understand and cooperate with study procedures including dressing care.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCG Vaccine.1 mL of reconstituted BCG vaccine given intradermally at baseline. | Drug | BCG Vaccine |
| Placebo.1 nL of diluent (saline) given intradermally at baseline | Other | Placebo Arm |
Primary outcome
To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities.
Time frame: 12 months
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.
4 secondary outcomes
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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 32031570Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585.
- Background: PubMed 32167524Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.
- Background: PubMed 32217556Chen T, Wu D, Chen H, Yan W, Yang D, Chen G, Ma K, Xu D, Yu H, Wang H, Wang T, Guo W, Chen J, Ding C, Zhang X, Huang J, Han M, Li S, Luo X, Zhao J, Ning Q. Clinical characteristics of 113 deceased patients with coronavirus disease 2019: retrospective study. BMJ. 2020 Mar 26;368:m1091. doi: 10.1136/bmj.m1091.
- Background: PubMed 32191259Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.
- Background: PubMed 32239127Cao J, Tu WJ, Cheng W, Yu L, Liu YK, Hu X, Liu Q. Clinical Features and Short-term Outcomes of 102 Patients with Coronavirus Disease 2019 in Wuhan, China. Clin Infect Dis. 2020 Jul 28;71(15):748-755. doi: 10.1093/cid/ciaa243.
- Background: PubMed 32310612Basu-Ray I, Almaddah NK, Vaqar S, Soos MP. Cardiac Manifestations of Coronavirus (COVID-19). 2024 Feb 12. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556152/
- Background: PubMed 32227120Danzi GB, Loffi M, Galeazzi G, Gherbesi E. Acute pulmonary embolism and COVID-19 pneumonia: a random association? Eur Heart J. 2020 May 14;41(19):1858. doi: 10.1093/eurheartj/ehaa254. No abstract available.
- Background: PubMed 32268022Zhang Y, Xiao M, Zhang S, Xia P, Cao W, Jiang W, Chen H, Ding X, Zhao H, Zhang H, Wang C, Zhao J, Sun X, Tian R, Wu W, Wu D, Ma J, Chen Y, Zhang D, Xie J, Yan X, Zhou X, Liu Z, Wang J, Du B, Qin Y, Gao P, Qin X, Xu Y, Zhang W, Li T, Zhang F, Zhao Y, Li Y, Zhang S. Coagulopathy and Antiphospholipid Antibodies in Patients with Covid-19. N Engl J Med. 2020 Apr 23;382(17):e38. doi: 10.1056/NEJMc2007575. Epub 2020 Apr 8.
- Background: PubMed 32291094Klok FA, Kruip MJHA, van der Meer NJM, Arbous MS, Gommers DAMPJ, Kant KM, Kaptein FHJ, van Paassen J, Stals MAM, Huisman MV, Endeman H. Incidence of thrombotic complications in critically ill ICU patients with COVID-19. Thromb Res. 2020 Jul;191:145-147. doi: 10.1016/j.thromres.2020.04.013. Epub 2020 Apr 10.
- Background: PubMed 32423970Alunno A, Carubbi F, Rodriguez-Carrio J. Storm, typhoon, cyclone or hurricane in patients with COVID-19? Beware of the same storm that has a different origin. RMD Open. 2020 May;6(1):e001295. doi: 10.1136/rmdopen-2020-001295.
- Background: PubMed 32174129Salehi S, Abedi A, Balakrishnan S, Gholamrezanezhad A. Coronavirus Disease 2019 (COVID-19): A Systematic Review of Imaging Findings in 919 Patients. AJR Am J Roentgenol. 2020 Jul;215(1):87-93. doi: 10.2214/AJR.20.23034. Epub 2020 Mar 14.
- Background: PubMed 32286675Stam HJ, Stucki G, Bickenbach J; European Academy of Rehabilitation Medicine. Covid-19 and Post Intensive Care Syndrome: A Call for Action. J Rehabil Med. 2020 Apr 15;52(4):jrm00044. doi: 10.2340/16501977-2677.
- Covid-19 Nursing Home DataLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Megan B Murray, MD, ScD principal investigator
Harvard Medical School (HMS and HSDM)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BCG Vaccine in people with Covid19, run by Harvard Medical School (HMS and HSDM).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy of BCG vaccination compared to placebo in reducing severe Covid-19 disease among elderly residents of skilled nursing facilities. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534803, which also lists 106 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.