NCT05643781

Tuberculosis as a Risk Factor for a Worse Outcome Post-Sars-CoV-2 Infection

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 157 (actual)
• Sponsor: The Aurum Institute NPC · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• COVID-19
• Tuberculosis
• Post-acute COVID-19 Syndrome

Timeline

• Start date: 2021-03-23
• Primary completion: 2022-11-30
• Completion: 2022-11-30
• First posted: 2022-12-09
• Last updated: 2023-01-11

Locations

1 site across 1 country: South Africa