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| Name | Class |
|---|---|
| Chris Hani Baragwanath Academic Hospital | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
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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):
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Co-TB Group | Follow up all participants from hospital discharge until 12 months post-Covid-19 infection. Conduct investigations assessing cardiopulmonary, socioeconomic, quality of life outcomes. No interventions. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Cardiac outcomes post-Covid-19. |
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Inclusion Criteria:
Exclusion Criteria:
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The study population comprises the general population (of 18 years and older), which is served by the study hospital. Those who cannot give informed consent, or are under imprisonment, or suffer from other medical or mental conditions and/or life under circumstances that may prevent the completion of 6 months follow up will also not be included.
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Rachow, PhD, med | Ludwig-Maximilians - University of Munich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Aurum Institute | Johannesburg | Gauteng | 2193 | South Africa |
Currently conducting study analysis with the database and once study is complete will discuss the plan to share IPD
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D014376 | Tuberculosis |
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Serum, whole blood (EDTA), PAXGene blood collected for Covid 19-serology-, inflammatory/transcriptomic- and immunology- analysis.
Determine Covid-19 pneumonia cardiac characteristics in our post-hospitalisation cohort up to 12 months post-infection.
| 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. | March 2021 to December 2022 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |