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

NCT05643781 | Completed

• 1 other identifier: AUR2-8-296
• Study Type: observational
• Target: 157
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19; Tuberculosis; Post-acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Hospitalisation and Covid-19 severity

  March 2021 to December 2022

• Cardiac outcomes post-Covid-19.

  March 2021 to December 2022

• Lung function assessment post-Covid-19.

  March 2021 to December 2022

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 procedures
• Be ≥ 18 years and \<70 years of age
• Having a diagnosis of SARS-CoV-2 infection, confirmed by PCR tests and/or chest CT-scan
• Willing 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 old
• Willingness to comply with the protocol and visit schedule, at the discretion of the investigator
• Having 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 participation

You may not qualify if:

• 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 cancer
• Has 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 imprisoned
• Confirmed or suspected pregnancy

Sponsors & Collaborators

• The Aurum Institute NPC: lead
• Chris Hani Baragwanath Academic Hospital: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

The Aurum Institute

Johannesburg, Gauteng, 2193, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, whole blood (EDTA), PAXGene blood collected for Covid 19-serology-, inflammatory/transcriptomic- and immunology- analysis.

MeSH Terms

Conditions

COVID-19; Tuberculosis; Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Rachow, PhD, med

  Division of Infectious Diseases and Tropical Medicine, Medical Center of the University of Munich (LMU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 9, 2022
• Study Start: March 23, 2021
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: January 11, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (1)