COVID-19NCT04347876
Outcome of COVID-19 Cases Based on Tuberculin Test: Can Previous BCG Alter the Prognosis?
An observational study of COVID-19 and BCG Vaccination, run by Assiut University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- COVID-19, BCG Vaccination
- What is being tested?
- Tuberculin test
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Apr 2020to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older 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)
Who may be able to join
- COVID-19 positive cases admitted to hospitals in Upper Egypt
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
AssiutU
Asyut, 71111
Aliae AR Mohamed-Hussein, +201222302352, aliaehussein@gmail.com
About this study
Official title: 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
- Conditions
- COVID-19, BCG Vaccination
- Being tested
- Tuberculin test
- Keywords
- Outcome, COVID-19 pneumonia, BCG, Tuberculin test positive, Egypt
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tuberculin testDiagnostic test
Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination
| Study group | Role | What they receive |
|---|---|---|
| Group A | COVID-19 positive with positive tuberculin test Receives: Diagnostic Test: Tuberculin test | |
| Group B | COVID-19 positive with negative tuberculin test Receives: Diagnostic Test: Tuberculin test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia severity index
severity of COVID-19 pneumonia
Measured: 2 weeks
Need for ICU admission
severe pneumonia indicating invasive or non invasive mechanical ventilation
Measured: 2 weeks
Secondary outcomes (2)
COVID -19 test conversion
number of days to cure from COVID-19 disease
Measured: 2 weeks
Mortality
frequency of fatalities
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start11 Apr 2020
- Primary completion16 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliae AR Mohamed Hussein, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347876
- Sponsor's protocol ID
- AssiutU12
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of COVID-19 Cases Admitted to Hospital and ICU With Positive Tuberculin Test: Can Previous BCG Alter the Prognosis?
- ClinicalTrials.gov ID
- NCT04347876
- Acronym / sponsor ID
- AssiutU12
- Conditions
- COVID-19, BCG Vaccination
- Keywords
- Outcome, COVID-19 pneumonia, BCG, Tuberculin test positive, Egypt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 11 Apr 2020 (actual)
- Primary completion
- 16 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Diagnostic Test: Tuberculin testCOVID-19 positive with positive tuberculin test |
| Group B | – | Diagnostic Test: Tuberculin testCOVID-19 positive with negative tuberculin test |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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)
Key inclusion criteria (1 listed)
- COVID-19 positive cases admitted to hospitals in Upper Egypt
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tuberculin testTest the delayed hypersensitivity reaction and immunity to previous BCG vaccination | Diagnostic test | Group A, Group B |
Primary outcome
Pneumonia severity index
Time frame: 2 weeks
severity of COVID-19 pneumonia
Need for ICU admission
Time frame: 2 weeks
severe pneumonia indicating invasive or non invasive mechanical ventilation
2 secondary outcomes
COVID -19 test conversion
Time frame: 2 weeks
Mortality
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and BCG Vaccination, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia severity index (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.