Outcome of COVID-19 Cases Based on Tuberculin Test: Can P... | NCT04347876

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

NCT04347876

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 15, 2020Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

COVID-19
BCG Vaccination

Interventions

Tuberculin test

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2020Actual

Primary Completion Date

Jun 16, 2020Estimated

Completion Date

Jun 30, 2020Estimated

First Submitted Date

Apr 14, 2020

First Submission Date that Met QC Criteria

Apr 14, 2020

First Posted Date

Apr 15, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2020

Last Update Posted Date

Apr 15, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A		COVID-19 positive with positive tuberculin test	Diagnostic Test: Tuberculin test
Group B		COVID-19 positive with negative tuberculin test	Diagnostic Test: Tuberculin test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tuberculin test	Diagnostic Test	Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

COVID-19 positive cases admitted to hospitals in Upper Egypt

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

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)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AssiutU	Recruiting	Asyut		71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014374	Tuberculin Test

Ancestor Terms

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided