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

April 14, 2020 updated by: Aliae AR Mohamed Hussein, Assiut University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt, 71111
        • Recruiting
        • AssiutU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pneumonia severity index
Time Frame: 2 weeks
severity of COVID-19 pneumonia
2 weeks
Need for ICU admission
Time Frame: 2 weeks
severe pneumonia indicating invasive or non invasive mechanical ventilation
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COVID -19 test conversion
Time Frame: 2 weeks
number of days to cure from COVID-19 disease
2 weeks
Mortality
Time Frame: 2 weeks
frequency of fatalities
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 11, 2020

Primary Completion (Anticipated)

June 16, 2020

Study Completion (Anticipated)

June 30, 2020

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 15, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AssiutU12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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