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NCT04347876 Clinical Trial

Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?

COVID-19 Clinical Trial

Official title:
Outcome of COVID-19 Cases Admitted to Hospital and ICU With Positive Tuberculin Test: Can Previous BCG Alter the Prognosis?

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04347876
Other study ID # AssiutU12
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 11, 2020
Est. completion date June 30, 2020

Study information
Verified date April 2020
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 30, 2020
Est. primary completion date June 16, 2020
Accepts healthy volunteers No
Gender All
Age group 12 Years to 80 Years
Eligibility Inclusion Criteria:

- COVID-19 positive cases admitted to hospitals in Upper Egypt

Exclusion Criteria:

- None

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Tuberculin test
Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination

Locations
Country Name City State
Egypt AssiutU Assiut

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pneumonia severity index severity of COVID-19 pneumonia 2 weeks
Primary Need for ICU admission severe pneumonia indicating invasive or non invasive mechanical ventilation 2 weeks
Secondary COVID -19 test conversion number of days to cure from COVID-19 disease 2 weeks
Secondary Mortality frequency of fatalities 2 weeks
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