Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?
Outcome of COVID-19 Cases Admitted to Hospital and ICU With Positive Tuberculin Test: Can Previous BCG Alter the Prognosis?
1 other identifier
observational
100
1 country
1
Brief Summary
There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with COVID-19 virus. Two clinical trials addressing this question are underway, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis. There is experimental evidence from both animal and human studies that the BCG vaccine has non-specific effects on the immune system. These effects have not been well characterized and their clinical relevance is unknown
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2020
CompletedFirst Submitted
Initial submission to the registry
April 14, 2020
CompletedFirst Posted
Study publicly available on registry
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedApril 15, 2020
April 1, 2020
2 months
April 14, 2020
April 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pneumonia severity index
severity of COVID-19 pneumonia
2 weeks
Need for ICU admission
severe pneumonia indicating invasive or non invasive mechanical ventilation
2 weeks
Secondary Outcomes (2)
COVID -19 test conversion
2 weeks
Mortality
2 weeks
Study Arms (2)
Group A
COVID-19 positive with positive tuberculin test
Group B
COVID-19 positive with negative tuberculin test
Interventions
Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination
Eligibility Criteria
All cases admitted with proven COVID-19 positive disease will be included, tested with tuberculin test positive and negative ( History of previous BCG or not)
You may qualify if:
- COVID-19 positive cases admitted to hospitals in Upper Egypt
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AssiutU
Asyut, 71111, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pulmonology
Study Record Dates
First Submitted
April 14, 2020
First Posted
April 15, 2020
Study Start
April 11, 2020
Primary Completion
June 16, 2020
Study Completion
June 30, 2020
Last Updated
April 15, 2020
Record last verified: 2020-04