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NCT04348370 · ClinicalTrials.gov registry record · Phase 4
BCG Vaccine for Health Care Workers as Defense Against COVID 19
A Phase 4 study, sponsored by Texas A&M University.
- Completed
- Registry status
- Phase 4
- Development phase
- 659
- Enrollment target
NCT04348370: Completed Phase 4 study, sponsored by Texas A&M University.
NCT04348370 is a Phase 4 study that has completed, run by Texas A&M University. The registered enrollment target is 659 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04348370, a Phase 4 study, has completed, sponsored by Texas A&M University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 659 participants
- Enrollment target
Study Summary
SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safeguard continuous patient care. Bacille Calmette-Guérin (BCG) is a vaccine against tuberculosis, with protective non-specific effects against other respiratory tract infections in in vitro and in vivo studies, and reported morbidity and mortality reductions as high as 70%. Furthermore, in our preliminary analysis, areas with existing BCG vaccination programs appear to have lower incidence and mortality from COVID191. The investigators hypothesize that BCG vaccination can reduce HCW infection and disease severity during the epidemic phase of SARS-CoV-2.
Primary Outcome
The primary outcome measure is development of COVID19 infection. This will be reported as the number of individuals receiving the intervention who are PCR-positive or seroconvert, defined as number of new cases during the 6 month time period
Interventions
- BIOLOGICAL Placebo Vaccine
- BIOLOGICAL BCG Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 659 participants |
| Start Date | 2020-04-20 |
| Est. Completion | 2023-04-21 |
| Phase | Phase 4 |
What the finished NCT04348370 record still lists
NCT04348370 is an interventional study that assigns participants to a tested intervention. The registered 659 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Vaccine is the first listed.
NCT04348370 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04348370 about?
NCT04348370 is a clinical study titled "BCG Vaccine for Health Care Workers as Defense Against COVID 19". SARS-CoV-2 spreads rapidly throughout the world. A large epidemic would seriously challenge the available hospital capacity, and this would be augmented by infection of healthcare workers (HCW). Strategies to prevent infection and disease severity of HCW are, therefore, desperately needed to safegua...
What is the current status of trial NCT04348370?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 659 participants. The study started on 2020-04-20. Estimated completion is 2023-04-21.
What interventions are being tested in trial NCT04348370?
The interventions under investigation include: Placebo Vaccine (BIOLOGICAL), BCG Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04348370?
This trial is sponsored by Texas A&M University, which has 95 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04348370's enrollment target sits among peer trials
659 121st of 2000 higher than 1,879 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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