COVID-19 Clinical Trial
— Co-TBOfficial title:
Tuberculosis as a Risk Factor for a Severe Course and Adverse Long-term Outcome of a Symptomatic Sars-CoV-2 Infection in Johannesburg, South Africa
NCT number | NCT05643781 |
Other study ID # | AUR2-8-296 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 23, 2021 |
Est. completion date | November 30, 2022 |
Verified date | January 2023 |
Source | The Aurum Institute NPC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study has two main objectives. First, the clinical characteristics and outcomes of hospitalized patients with symptomatic Covid-19 disease will be compared between persons with a history of past or current TB infection or disease and those, who have had no TB history. The possible impact of an HIV-coinfection will be also addressed in the planned investigations and analysis. Second, the long-term consequences and clinical outcomes of Covid-19 up to 12 months post-infection will be analysed in both groups (with and without TB history) with the main focus on cardio-pulmonary outcomes.
Status | Completed |
Enrollment | 157 |
Est. completion date | November 30, 2022 |
Est. primary completion date | November 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Willingness to provide a written informed consent or witnessed oral consent in the case of illiteracy for participation in the study prior to all study-related procedures - Be = 18 years and <70 years of age - Having a diagnosis of SARS-CoV-2 infection, confirmed by PCR tests and/or chest CT-scan - Willing to be tested for active and latent M.tb infection and to provide information on previous TB disease episodes (including agreement for confirmation of active TB disease by the investigators, e.g. via NTP/lab registration number) - Willing to be tested for HIV, if status is not known or the last documented negative is more than 4 weeks old - Willingness to comply with the protocol and visit schedule, at the discretion of the investigator - Having a firm home address that is readily accessible for visiting and is willing to inform the study team of any change of address during study participation Exclusion Criteria: - Has a recent history of a medical condition that is the leading cause for the current clinical symptoms and/or survival, e.g. advanced stages of cancer - Has severe medical or psychiatric condition which in the opinion of the site investigator or designee, might interfere with the ability to give true informed consent and to adhere to the study requirements. - Is currently imprisoned - Confirmed or suspected pregnancy |
Country | Name | City | State |
---|---|---|---|
South Africa | The Aurum Institute | Johannesburg | Gauteng |
Lead Sponsor | Collaborator |
---|---|
The Aurum Institute NPC | Chris Hani Baragwanath Academic Hospital, Ludwig-Maximilians - University of Munich |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Covid-19 recovery and course and the impact of tuberculosis (TB) or no tuberculosis infection. | Describe the long-term clinical characteristics and course of recovery post-Covid-19 and compare patients groups with TB infection and those without TB infection. TB infection will be determined by a history of TB disease, or current TB disease on medical records, and latent TB infection will be determined by Interferon-Gamma release assay blood test. Those with any positive of the above tests will be considered to have TB infection, and those with all negative tests will be considered to have no TB infection. |
March 2021 to December 2022 | |
Secondary | Hospitalisation and Covid-19 severity | Describe Covid-19 pneumonia hospitalisation with Covid severity in our post-hospitalisation cohort up to 12 months post-infection. | March 2021 to December 2022 | |
Secondary | Cardiac outcomes post-Covid-19. | Determine Covid-19 pneumonia cardiac characteristics in our post-hospitalisation cohort up to 12 months post-infection. | March 2021 to December 2022 | |
Secondary | Lung function assessment post-Covid-19. | Describe respiratory assessment in our post-hospitalisation cohort up to 12 months post-infection. | March 2021 to December 2022 |
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