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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347876
Recruitment Status : Unknown
Verified April 2020 by Aliae AR Mohamed Hussein, Assiut University.
Recruitment status was:  Recruiting
First Posted : April 15, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Aliae AR Mohamed Hussein, Assiut University

Study Description
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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

Condition or disease Intervention/treatment
COVID-19 BCG Vaccination Diagnostic Test: Tuberculin test

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Outcome of COVID-19 Cases Admitted to Hospital and ICU With Positive Tuberculin Test: Can Previous BCG Alter the Prognosis?
Actual Study Start Date : April 11, 2020
Estimated Primary Completion Date : June 16, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group A
COVID-19 positive with positive tuberculin test
 Diagnostic Test: Tuberculin test
Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination
Group B
COVID-19 positive with negative tuberculin test
 Diagnostic Test: Tuberculin test
Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination


Outcome Measures
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Primary Outcome Measures :
  1. Pneumonia severity index [ Time Frame: 2 weeks ]
    severity of COVID-19 pneumonia

  2. Need for ICU admission [ Time Frame: 2 weeks ]
    severe pneumonia indicating invasive or non invasive mechanical ventilation


Secondary Outcome Measures :
  1. COVID -19 test conversion [ Time Frame: 2 weeks ]
    number of days to cure from COVID-19 disease

  2. Mortality [ Time Frame: 2 weeks ]
    frequency of fatalities


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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)
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347876


Locations
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Egypt
AssiutU Recruiting
Assiut, Egypt, 71111
Contact: Aliae AR Mohamed-Hussein    +201222302352    aliaehussein@gmail.com   
Sponsors and Collaborators
Assiut University
More Information
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Responsible Party: Aliae AR Mohamed Hussein, Professor of Pulmonology, Assiut University
ClinicalTrials.gov Identifier: NCT04347876    
Other Study ID Numbers: AssiutU12
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aliae AR Mohamed Hussein, Assiut University:
Outcome
COVID-19 pneumonia
BCG
Tuberculin test positive
Egypt
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases