COVID-19Co-TBNCT05643781
Tuberculosis as a Risk Factor for a Worse Outcome Post-Sars-CoV-2 Infection
An observational study of COVID-19 and Tuberculosis, run by The Aurum Institute NPC at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID-19, Tuberculosis, Post-acute COVID-19 Syndrome
- How many people
- 157 participants
- Where
- 1 siteSouth Africa
- Study dates
- 23 Mar 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Medical subject headings
- COVID-19, Tuberculosis, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: March 2021 to December 2022
Secondary outcomes (3)
Hospitalisation and Covid-19 severity
Describe Covid-19 pneumonia hospitalisation with Covid severity in our post-hospitalisation cohort up to 12 months post-infection.
Measured: 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.
Measured: 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.
Measured: March 2021 to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start23 Mar 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Aurum Institute NPC
- Sponsor type
- University, hospital or other
- Collaborators
- Chris Hani Baragwanath Academic Hospital, Ludwig-Maximilians - University of Munich
- Responsible party
- Sponsor
- Investigators
- Andrea Rachow, PhD, med, Principal investigator, LMU Klinikum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643781
- Sponsor's protocol ID
- AUR2-8-296
- Acronym
- Co-TB
- Status last verified
- Jan 2023
- First submitted
- 20 Oct 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Currently conducting study analysis with the database and once study is complete will discuss the plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05643781
- Acronym / sponsor ID
- Co-TB / AUR2-8-296
- Conditions
- COVID-19, Tuberculosis, Post-acute COVID-19 Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- The Aurum Institute NPCUniversity, hospital or other
- Collaborators
- Chris Hani Baragwanath Academic Hospital, Ludwig-Maximilians - University of Munich
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Covid-19 recovery and course and the impact of tuberculosis (TB) or no tuberculosis infection.
Time frame: March 2021 to December 2022
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.
3 secondary outcomes
Hospitalisation and Covid-19 severity
Time frame: March 2021 to December 2022
Cardiac outcomes post-Covid-19.
Time frame: March 2021 to December 2022
Lung function assessment post-Covid-19.
Time frame: March 2021 to December 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2023.
- Individual participant dataSharing planned: No. Currently conducting study analysis with the database and once study is complete will discuss the plan to share IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Rachow, PhD, med principal investigator
LMU Klinikum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Tuberculosis, run by The Aurum Institute NPC at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Covid-19 recovery and course and the impact of tuberculosis (TB) or no tuberculosis infection. (time frame: March 2021 to December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2023.