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Completed
NCT05643781
Tuberculosis as a Risk Factor for a Worse Outcome Post-Sars-CoV-2 Infection
Conditions: COVID-19, Tuberculosis, Post-acute COVID-19 Syndrome
Sex: All
Ages: 18 Years – 70 Years
Enrollment: 157
Sponsor: The Aurum Institute NPC
Location: South Africa
Summary
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.
Eligibility Criteria
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 proceduresBe ≥ 18 years and <70 years of ageHaving a diagnosis of SARS-CoV-2 infection, confirmed by PCR tests and/or chest CT-scanWilling 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 oldWillingness to comply with the protocol and visit schedule, at the discretion of the investigatorHaving 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 participationExclusion 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 cancerHas 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 imprisonedConfirmed or suspected pregnancy
Source: ClinicalTrials.gov (NCT05643781). StuddyBuddy aggregates publicly available trial information.
