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.
This study is retrospective/prospective clinical observational study. Primary Objective, Study Phase A (hospitalization, retrospective data collection): * To describe the development and characteristics of Covid-19 pneumonia, clinically and using radiological methods (i.e. CT-thorax) * To describe disease severity of Covid-19 disease, including treatment in Intensive Care Unit (ICU) and ventilation support measures * To describe different types of organ failures apart from respiratory failure (e.g. kidney, liver, heart) * To describe treatment outcomes at discharge, including cause of death * To assess the significance of additional risk factors such as HIV infection, smoking, malnutrition, etc., for the clinical course and characteristics of a Covid-19 disease Primary Objective, Study Phase B (after end of hospitalization, prospective data collection): The primary objective of the study phase B (after end of hospitalization) is the description of Covid-19 sequelae (focus on cardio-pulmonary morbidity) in patients with and without previous TB disease during a six month follow up period after discharge from hospital, including: * the description (characteristics and severity) of abnormal function tests and clinical examination results (e.g. in lung function measurement, cardiac tests and ECG, kidney function, neurological \& mental tests) * the definition of time to healing (ad integrum) after a Covid-19 infection * the studying of chronic restrictions of the long-term quality of life at 12 months after discharge from hospital that are based on chronic organ failures and mental disorders * the assessment of exacerbations of chronic organ failures, hospitalizations and deaths in 12 months phase after discharge from hospital Secondary Objective(s): * To collect longitudinal data that could allow for further insights on whether previous Covid-19 disease results in an increased risk for re-activation of /infection with M. tuberculosis * To perform longitudinal immunological investigations in a sub-set of patients to study Covid-19- immune-activation, depending on M.tb and/or HIVcoinfection status
Study Type
OBSERVATIONAL
Enrollment
157
The Aurum Institute
Johannesburg, Gauteng, South Africa
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.
Time frame: March 2021 to December 2022
Hospitalisation and Covid-19 severity
Describe Covid-19 pneumonia hospitalisation with Covid severity in our post-hospitalisation cohort up to 12 months post-infection.
Time frame: March 2021 to December 2022
Cardiac outcomes post-Covid-19.
Determine Covid-19 pneumonia cardiac characteristics in our post-hospitalisation cohort up to 12 months post-infection.
Time frame: March 2021 to December 2022
Lung function assessment post-Covid-19.
Describe respiratory assessment in our post-hospitalisation cohort up to 12 months post-infection.
Time frame: March 2021 to December 2022
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