Long COVIDChaLOCNCT05445713
A Cross-sectional, Observational Study to Characterise Long COVID-19 in an Urban Sample of South African Adults
An observational study of Long COVID, run by University of Witwatersrand, South Africa at 2 sites in South Africa.
Trial summary
"Long-COVID'' (also known as post-COVID-19 syndrome, post-acute sequelae of COVID-19, or chronic COVID syndrome, used here as 'Long-COVID' for brevity), is a complex array of postconvalescence symptoms following SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Long COVID
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 2 sitesSouth Africa
- Study dates
- 10 Aug 2022to 25 Nov 2024
- 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 100 years
- All sexes
- Adult, Older adult
Study population: Adults at least 18 years of age with previous confirmed SARS-CoV-2 infection (symptomatic or asymptomatic) will be invited to participate. Approximately 400 participants will be enrolled.
Who may be able to join
- Able and willing to provide written or electronic informed consent for the baseline visit prior to any study-specific assessment or procedure.
- Age at least 18 years at the time of signing the informed consent form.
- Previous asymptomatic SARS-CoV-2 infection, confirmed through a documented positive PCR, antigen, or antibody test, at least six months prior to the baseline visit [Cohort 1 only] or, previous symptomatic SARS-CoV-2 infection for which hospitalisation was not required, confirmed through a documented positive PCR or antigen test at the time, at least six months prior to the baseline visit [Cohort 2 only] or, previous hospitalisation for management and treatment of COVID-19 confirmed through a documented positive PCR or antigen test at the time, at least six months prior to the baseline visit [Cohort 3 only] or, previous asymptomatic or symptomatic SARS-CoV-2 infection, confirmed through a documented positive PCR, antigen, or antibody test, at least six months prior to the baseline visit and received a COVID-19 vaccine in a non-placebo arm of a COVID-19 vaccine study during 2020 [Cohort 4 only].
- Willing to consent to verification of vaccination status on the national Electronic Vaccination Data System (EVDS).
- Access to a reliable telephone or other device permitting information transfer.
Who cannot join
- Symptomatic SARS-CoV-2 infection at any stage prior to the baseline visit [Cohort 1 only].
- SARS-CoV-2 infection, confirmed through a documented positive PCR, antigen, or antibody test, prior to vaccination in a non-placebo arm of a COVID-19 vaccine study during 2020 [Cohort 4 only].
- COVID-19 within three months of the baseline visit.
- Personnel (e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
- Any physical, mental, or social condition, that, in the Investigator's judgment, might interfere with the completion of the baseline assessments and evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.
- Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
Trial locations and contacts
2 sites in 1 country.
South Africa2 sites
Sunnyside Office Park
Johannesburg, Gauteng, 2193
Charlotte Maxeke Johannesburg Academic Hospital (CMJAH)
Johannesburg, Gauteng, 2198
About this study
Official title: A Cross-sectional, Observational Study to Characterise Long-COVID in an Urban Sample of South African Adults
"Long-COVID'' (also known as post-COVID-19 syndrome, post-acute sequelae of COVID-19, or chronic COVID syndrome, used here as 'Long-COVID' for brevity), is a complex array of postconvalescence symptoms following SARS-CoV-2 infection. The syndrome, common in COVID-19 survivors, can affect every organ system through as-yet uncharacterised but presumed immunological mechanisms. Prevalence depends on the definition used and time-period of follow-up, as well as the population being studied. The syndrome has been associated with significant and persistent disability in some survivors but has been hampered, until recently, by lack of a clinical definition, diagnostic criteria, and objective measures of disease or disability [1]. A Delphi-informed initial World Health Organisation (WHO) clinical definition was released in early October 2021 but has attracted much criticism from both clinicians and survivors for a host of reasons, ranging from a lack of precision to a lack of inclusion [2].
Further complicating the syndrome is the context in which the SARS-CoV-2 epidemic occurred, which was associated with severe lockdowns in many countries (including South Africa) with social isolation, widespread fear and disinformation, widespread economic hardship, and loss of family and acquaintances, all of which contribute to symptoms (psychiatric and sleep disturbances, pain, and other syndromes) reported to be associated with Long-COVID. Finally, many Long-COVID symptoms overlap with those seen in patients hospitalised for any severe illness, especially those admitted to intensive care and ventilated. However, the proliferation of literature reporting associations of Long-COVID symptoms with more severe COVID-19 disease, and objective immunological, radiological, and organ-specific dysfunction in those reporting symptoms, suggests that the entity is real. The pathogenesis of Long-COVID is poorly understood, but this association with more severe disease - where immune dysregulation plays a major role in those with hospitalization, respiratory failure, and death - suggests an immune-mediated inflammatory dysfunction that may impact all organs [3-14].
The sheer rapidity of four major infection waves in South Africa, the initial focus on containing the hospital burden of those with severe illness, and subsequent emphasis on the roll-out of a mass vaccination program, has left little space for studying SARS-COV-2 sequalae in survivors. This group, loosely and inaccurately termed "recovered'' in South African reporting, were largely unvaccinated or partly vaccinated at the time of infection, leaving them at risk of developing Long-COVID.
Read the detailed description
This is a single-centre, follow-up, observational, cross-sectional study of four distinct, longitudinal cohorts. Extensive clinical history will be obtained from each participant, and symptom questionnaire characterisation of Long-COVID (with a strong focus on organ-specific dysfunction, psychiatric, sleep, and pain parameters - all of which appear to be major features of Long-COVID), as well as laboratory and genetic characterisation will be performed. A subset of each cohort will be randomly selected for more specific syndrome characterisation related to sleep and pain, respiratory, cardiology, renal and glucose metabolism.
The consequences of Long-COVID will be described and compared in four large, well-described clinical cohorts of African patients surviving SARS-CoV-2:
- Cohort 1: asymptomatic subjects found to be PCR/antigen/antibody-positive during routine screening for SARS-CoV-2 infection
- Cohort 2: symptomatic outpatients who were confirmed to have COVID-19 through a positive PCR/antigen test
- Cohort 3: inpatients surviving hospitalisation for severe COVID-19 and who were PCR/antigen-positive
- Cohort 4: participants vaccinated in clinical trials in 2020 prior to widespread community exposure, and hence protected from severe COVID-19 (and possibly Long-COVID) if subsequently infected.
After obtaining informed consent from potential participants, a single cross-sectional, baseline visit will be conducted for each participant. Demographic data, clinical history (including COVID-19 history, targeted symptoms, and risk factors), COVID-19 vaccination dates (if administered), and details of previous and concomitant medications will be collected. Multiple questionnaires related to psychiatric screening, psychosocial factors, work function assessment, sleep quality, and pain assessment will be administered. Respiratory and cardiac function will be evaluated through a dyspnoea scale, walking test and an ECG. Laboratory evaluations will include a full blood count, serum chemistry, liver function tests, renal function assessment, inflammatory markers, and DNA extraction for genotyping. Blood and urine samples will be stored locally for possible future analysis. Human immunodeficiency virus (HIV) testing will be performed for participants consenting to this optional assessment.
After the baseline visit, participants with Long-COVID will be identified using the WHO clinical definition and general health assessments [2]. Randomly selected sub-groups of participants with, and without, Long-COVID will be selected from each of the four cohorts for additional investigations through participation in the following sub-studies:
- Respiratory evaluation: dyspnoea assessment, high-resolution computed tomography (CT) scan, lung function studies including spirometry and diffusion capacity (DLCO) [Section 7.2.2.1]
- Cardiac evaluation: clinical history and examination, serial blood pressure, six minute walk test (distance), ECG, echocardiogram including speckle tracking, cardiac magnetic resonance imaging (MRI), creatine kinase MB fraction (CK-MB), cardiac troponin T (cTnT), prohormone brain natriuretic peptide (pro-BNP), and possible coronary angiography in patients with acute coronary syndromes and unstable angina [Section 7.2.2.2]
- Psychiatric and neuroendocrine evaluation: questionnaires/surveys, semi-structured interview, home visit, saliva cortisol analysis, collection of diary data, actigraphy, adrenocorticotropic hormone (ACTH) challenge (cosyntropin sensitivity test [CST]), cellular immunity assessment [Section 7.2.2.3]
- Sleep evaluation: questionnaires, actigraphy with sleep diaries, polysomnography (PSN) [Section 7.2.2.4]
- Pain evaluation: quantitative sensory testing (QST) and conditioned pain modulation (CPM) assessments [Section 7.2.2.5]
- Glucose metabolism evaluation: oral glucose tolerance test (OGTT) including assessment of glucose, insulin, and c-peptide to estimate insulin sensitivity and beta-cell function [16]. [Section 7.2.2.6] Abnormalities detected in the assessments (including undiagnosed mental health issues) will be managed by on-study medical personnel with referral as appropriate.
- Conditions
- Long COVID
- Medical subject headings
- 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 |
|---|---|---|
| Cohort 1 | Asymptomatic subjects found to be PCR/antigen/antibody-positive during routine screening for SARS-CoV-2 infection | |
| Cohort 2 | Symptomatic outpatients who were confirmed to have COVID-19 through a positive PCR/antigen test | |
| Cohort 3 | Inpatients surviving hospitalisation for severe COVID-19 and who were PCR/antigen-positive | |
| Cohort 4 | Participants vaccinated in clinical trials in 2020 prior to widespread community exposure, and hence protected from severe COVID-19 (and possibly Long-COVID) if subsequently infected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterise Long-COVID in four cohorts of patients
Incidence, severity, and duration of Long-COVID symptoms.
Measured: 6 Months
Secondary outcomes (38)
Inflammatory markers
High sensitivity C-reactive protein (hs-CRP)
Measured: 6 Months
Inflammatory markers
Interleukin-1
Measured: 6 Months
Inflammatory markers
Interleukin-6 (IL-6)
Measured: 6 Months
Inflammatory markers
Interleukin-8 (IL-8)
Measured: 6 Months
Inflammatory markers
Tumour necrosis factor alpha
Measured: 6 Months
Inflammatory markers
Tumour necrosis factor alpha receptor-1 (TNFR1)
Measured: 6 Months
Inflammatory markers
Monocyte chemoattractant protein-1 (MCP-1)
Measured: 6 Months
Psychological profiles
Headache Impact Test-6
Measured: 6 Months
Psychological profiles
Patient Health Questionnaire-9
Measured: 6 Months
Psychological profiles
Generalised Anxiety Disorder 7
Measured: 6 Months
Psychological profiles
PTSD Checklist for DSM-5 - Civilian Version
Measured: 6 Months
Psychological profiles
Mood Disorder Questionnaire; a short screening tool evaluating the symptoms of bipolar disorder
Measured: 6 Months
Psychological profiles
Montreal Cognitive Assessment
Measured: 6 Months
Psychological profiles
Daily Fatigue Impact Scale; a survey tool that assesses physical, cognitive, and psychosocial dimensions of fatigue in everyday life
Measured: 6 Months
Psychosocial exposures
COVID-19 related stress questionnaire
Measured: 6 months
Psychosocial exposures
Multidimensional Scale of Perceived Social Support; a brief research tool designed to measure perceptions of support from 3 sources - family, friends, and a significant other; the scale is comprised of a total of 12 items, with 4 items for each subscale
Measured: 6 months
Psychosocial exposures
Perceived Stress Scale
Measured: 6 months
Psychosocial exposures
Adverse Childhood Experiences tool
Measured: 6 months
Work performance in employed participants
Normal activities and work productivity questionnaire; daily diaries
Measured: 6 months
Sleep quality and disorders
Pittsburgh Sleep Quality Index
Measured: 6 months
Sleep quality and disorders
Epworth Sleepiness Scale
Measured: 6 months
Sleep quality and disorders
Berlin Questionnaire for risk of sleep apnoea
Measured: 6 months
Sleep quality and disorders
International Restless Legs Syndrome Severity Scale
Measured: 6 months
Sleep quality and disorders
Sleep quality and mood visual analogue scale
Measured: 6 months
Pain experience
Brief Pain Inventory
Measured: 6 months
Cardiorespiratory function
Modified Medical Research Council Dyspnoea Scale
Measured: 6 months
Cardiorespiratory function
Six-minute walk test (distance)
Measured: 6 months
Cardiorespiratory function
ECG parameters and morphology
Measured: 6 months
Standard laboratory parameters
Full blood count
Measured: 6 months
Standard laboratory parameters
Serum chemistry
Measured: 6 months
Standard laboratory parameters
Liver function tests
Measured: 6 months
Standard laboratory parameters
Glucose, HbA1C
Measured: 6 months
Renal function
Creatinine clearance
Measured: 6 months
Renal function
Cystatin-C
Measured: 6 months
Renal function
Urine dipstick parameters
Measured: 6 months
Renal function
Urine albumin-to-creatinine ratio
Measured: 6 months
Host genetic factors that may be associated with Long-COVID
Genotyping results
Measured: 6 months
Host genetic factors that may be associated with Long-COVID
DNA sequencing results
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start10 Aug 2022
- Primary completion30 Oct 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Cross-sectional
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Francois Venter, University of Witwatersrand, South Africa
- Investigators
- Francois WD Venter, MBBCh, Principal investigator, Ezintsha, a division of Wits Health ConsortiumSimiso M Sokhela, MBBCh, Study director, Ezintsha, a division of Wits Health ConsortiumNonkululeko Mashabane, BPharm, Study chair, Ezintsha, a division of Wits Health Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445713
- Sponsor's protocol ID
- EZ-FV-028
- Acronym
- ChaLOC
- Status last verified
- Mar 2025
- First submitted
- 4 Jul 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional, Observational Study to Characterise Long-COVID in an Urban Sample of South African Adults
- ClinicalTrials.gov ID
- NCT05445713
- Acronym / sponsor ID
- ChaLOC / EZ-FV-028
- Conditions
- Long COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- 10 Aug 2022 (actual)
- Primary completion
- 30 Oct 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 6 Jul 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.
"Long-COVID'' (also known as post-COVID-19 syndrome, post-acute sequelae of COVID-19, or chronic COVID syndrome, used here as 'Long-COVID' for brevity), is a complex array of postconvalescence symptoms following SARS-CoV-2 infection. The syndrome, common in COVID-19 survivors, can affect every organ system through as-yet uncharacterised but presumed immunological mechanisms. Prevalence depends on the definition used and time-period of follow-up, as well as the population being studied. The syndrome has been associated with significant and persistent disability in some survivors but has been hampered, until recently, by lack of a clinical definition, diagnostic criteria, and objective measures of disease or disability [1]. A Delphi-informed initial World Health Organisation (WHO) clinical definition was released in early October 2021 but has attracted much criticism from both clinicians and survivors for a host of reasons, ranging from a lack of precision to a lack of inclusion [2].
Further complicating the syndrome is the context in which the SARS-CoV-2 epidemic occurred, which was associated with severe lockdowns in many countries (including South Africa) with social isolation, widespread fear and disinformation, widespread economic hardship, and loss of family and acquaintances, all of which contribute to symptoms (psychiatric and sleep disturbances, pain, and other syndromes) reported to be associated with Long-COVID. Finally, many Long-COVID symptoms overlap with those seen in patients hospitalised for any severe illness, especially those admitted to intensive care and ventilated. However, the proliferation of literature reporting associations of Long-COVID symptoms with more severe COVID-19 disease, and objective immunological, radiological, and organ-specific dysfunction in those reporting symptoms, suggests that the entity is real. The pathogenesis of Long-COVID is poorly understood, but this association with more severe disease - where immune dysregulation plays a major role in those with hospitalization, respiratory failure, and death - suggests an immune-mediated inflammatory dysfunction that may impact all organs [3-14].
The sheer rapidity of four major infection waves in South Africa, the initial focus on containing the hospital burden of those with severe illness, and subsequent emphasis on the roll-out of a mass vaccination program, has left little space for studying SARS-COV-2 sequalae in survivors. This group, loosely and inaccurately termed "recovered'' in South African reporting, were largely unvaccinated or partly vaccinated at the time of infection, leaving them at risk of developing Long-COVID.
Detailed description
This is a single-centre, follow-up, observational, cross-sectional study of four distinct, longitudinal cohorts. Extensive clinical history will be obtained from each participant, and symptom questionnaire characterisation of Long-COVID (with a strong focus on organ-specific dysfunction, psychiatric, sleep, and pain parameters - all of which appear to be major features of Long-COVID), as well as laboratory and genetic characterisation will be performed. A subset of each cohort will be randomly selected for more specific syndrome characterisation related to sleep and pain, respiratory, cardiology, renal and glucose metabolism.
The consequences of Long-COVID will be described and compared in four large, well-described clinical cohorts of African patients surviving SARS-CoV-2:
- Cohort 1: asymptomatic subjects found to be PCR/antigen/antibody-positive during routine screening for SARS-CoV-2 infection
- Cohort 2: symptomatic outpatients who were confirmed to have COVID-19 through a positive PCR/antigen test
- Cohort 3: inpatients surviving hospitalisation for severe COVID-19 and who were PCR/antigen-positive
- Cohort 4: participants vaccinated in clinical trials in 2020 prior to widespread community exposure, and hence protected from severe COVID-19 (and possibly Long-COVID) if subsequently infected.
After obtaining informed consent from potential participants, a single cross-sectional, baseline visit will be conducted for each participant. Demographic data, clinical history (including COVID-19 history, targeted symptoms, and risk factors), COVID-19 vaccination dates (if administered), and details of previous and concomitant medications will be collected. Multiple questionnaires related to psychiatric screening, psychosocial factors, work function assessment, sleep quality, and pain assessment will be administered. Respiratory and cardiac function will be evaluated through a dyspnoea scale, walking test and an ECG. Laboratory evaluations will include a full blood count, serum chemistry, liver function tests, renal function assessment, inflammatory markers, and DNA extraction for genotyping. Blood and urine samples will be stored locally for possible future analysis. Human immunodeficiency virus (HIV) testing will be performed for participants consenting to this optional assessment.
After the baseline visit, participants with Long-COVID will be identified using the WHO clinical definition and general health assessments [2]. Randomly selected sub-groups of participants with, and without, Long-COVID will be selected from each of the four cohorts for additional investigations through participation in the following sub-studies:
- Respiratory evaluation: dyspnoea assessment, high-resolution computed tomography (CT) scan, lung function studies including spirometry and diffusion capacity (DLCO) [Section 7.2.2.1]
- Cardiac evaluation: clinical history and examination, serial blood pressure, six minute walk test (distance), ECG, echocardiogram including speckle tracking, cardiac magnetic resonance imaging (MRI), creatine kinase MB fraction (CK-MB), cardiac troponin T (cTnT), prohormone brain natriuretic peptide (pro-BNP), and possible coronary angiography in patients with acute coronary syndromes and unstable angina [Section 7.2.2.2]
- Psychiatric and neuroendocrine evaluation: questionnaires/surveys, semi-structured interview, home visit, saliva cortisol analysis, collection of diary data, actigraphy, adrenocorticotropic hormone (ACTH) challenge (cosyntropin sensitivity test [CST]), cellular immunity assessment [Section 7.2.2.3]
- Sleep evaluation: questionnaires, actigraphy with sleep diaries, polysomnography (PSN) [Section 7.2.2.4]
- Pain evaluation: quantitative sensory testing (QST) and conditioned pain modulation (CPM) assessments [Section 7.2.2.5]
- Glucose metabolism evaluation: oral glucose tolerance test (OGTT) including assessment of glucose, insulin, and c-peptide to estimate insulin sensitivity and beta-cell function [16]. [Section 7.2.2.6] Abnormalities detected in the assessments (including undiagnosed mental health issues) will be managed by on-study medical personnel with referral as appropriate.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Asymptomatic subjects found to be PCR/antigen/antibody-positive during routine screening for SARS-CoV-2 infection |
| Cohort 2 | – | –Symptomatic outpatients who were confirmed to have COVID-19 through a positive PCR/antigen test |
| Cohort 3 | – | –Inpatients surviving hospitalisation for severe COVID-19 and who were PCR/antigen-positive |
| Cohort 4 | – | –Participants vaccinated in clinical trials in 2020 prior to widespread community exposure, and hence protected from severe COVID-19 (and possibly Long-COVID) if subsequently infected. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adults at least 18 years of age with previous confirmed SARS-CoV-2 infection (symptomatic or asymptomatic) will be invited to participate. Approximately 400 participants will be enrolled.
Key inclusion criteria (5 listed)
- Able and willing to provide written or electronic informed consent for the baseline visit prior to any study-specific assessment or procedure.
- Age at least 18 years at the time of signing the informed consent form.
- Previous asymptomatic SARS-CoV-2 infection, confirmed through a documented positive PCR, antigen, or antibody test, at least six months prior to the baseline visit [Cohort 1 only] or, previous symptomatic SARS-CoV-2 infection for which hospitalisation was not required, confirmed through a documented positive PCR or antigen test at the time, at least six months prior to the baseline visit [Cohort 2 only] or, previous hospitalisation for management and treatment of COVID-19 confirmed through a documented positive PCR or antigen test at the time, at least six months prior to the baseline visit [Cohort 3 only] or, previous asymptomatic or symptomatic SARS-CoV-2 infection, confirmed through a documented positive PCR, antigen, or antibody test, at least six months prior to the baseline visit and received a COVID-19 vaccine in a non-placebo arm of a COVID-19 vaccine study during 2020 [Cohort 4 only].
- Willing to consent to verification of vaccination status on the national Electronic Vaccination Data System (EVDS).
- Access to a reliable telephone or other device permitting information transfer.
Key exclusion criteria (6 listed)
- Symptomatic SARS-CoV-2 infection at any stage prior to the baseline visit [Cohort 1 only].
- SARS-CoV-2 infection, confirmed through a documented positive PCR, antigen, or antibody test, prior to vaccination in a non-placebo arm of a COVID-19 vaccine study during 2020 [Cohort 4 only].
- COVID-19 within three months of the baseline visit.
- Personnel (e.g., investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
- Any physical, mental, or social condition, that, in the Investigator's judgment, might interfere with the completion of the baseline assessments and evaluations. The Investigator should make this determination in consideration of the volunteer's medical history.
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
To characterise Long-COVID in four cohorts of patients
Time frame: 6 Months
Incidence, severity, and duration of Long-COVID symptoms.
38 secondary outcomes
Inflammatory markers
Time frame: 6 Months
Inflammatory markers
Time frame: 6 Months
Inflammatory markers
Time frame: 6 Months
Inflammatory markers
Time frame: 6 Months
Inflammatory markers
Time frame: 6 Months
Inflammatory markers
Time frame: 6 Months
Inflammatory markers
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychological profiles
Time frame: 6 Months
Psychosocial exposures
Time frame: 6 months
Psychosocial exposures
Time frame: 6 months
Psychosocial exposures
Time frame: 6 months
Psychosocial exposures
Time frame: 6 months
Work performance in employed participants
Time frame: 6 months
Sleep quality and disorders
Time frame: 6 months
Sleep quality and disorders
Time frame: 6 months
Sleep quality and disorders
Time frame: 6 months
Sleep quality and disorders
Time frame: 6 months
Sleep quality and disorders
Time frame: 6 months
Pain experience
Time frame: 6 months
Cardiorespiratory function
Time frame: 6 months
Cardiorespiratory function
Time frame: 6 months
Cardiorespiratory function
Time frame: 6 months
Standard laboratory parameters
Time frame: 6 months
Standard laboratory parameters
Time frame: 6 months
Standard laboratory parameters
Time frame: 6 months
Standard laboratory parameters
Time frame: 6 months
Renal function
Time frame: 6 months
Renal function
Time frame: 6 months
Renal function
Time frame: 6 months
Renal function
Time frame: 6 months
Host genetic factors that may be associated with Long-COVID
Time frame: 6 months
Host genetic factors that may be associated with Long-COVID
Time frame: 6 months
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 26 Mar 2025.
- Individual participant dataSharing planned: Yes. The data that will be shared is all of the individual participant data collected during the trial, after deidentification.
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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.
Francois WD Venter, MBBCh principal investigator
Ezintsha, a division of Wits Health Consortium
Simiso M Sokhela, MBBCh study director
Ezintsha, a division of Wits Health Consortium
Nonkululeko Mashabane, BPharm study chair
Ezintsha, a division of Wits Health Consortium
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Long COVID, run by University of Witwatersrand, South Africa at 2 sites 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 5 inclusion and 6 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 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
To characterise Long-COVID in four cohorts of patients (time frame: 6 Months). 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 26 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.