Tuberculosis as a Risk Factor for a Worse Outcome Post-Sars-CoV-2 Infection
Condition: COVID-19; Tuberculosis; Post-acute COVID-19 Syndrome
MeSH terms: COVID-19; Tuberculosis; Post-Acute COVID-19 Syndrome
Study type: Observational

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.
    

Detailed description: 
      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
    

Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        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.
      
Biospecimen description: 
      Serum, whole blood (EDTA), PAXGene blood collected for Covid 19-serology-,
      inflammatory/transcriptomic- and immunology- analysis.