NCT05445713: ChaLOC

A Cross-sectional, Observational Study to Characterise Long COVID-19 in an Urban Sample of South African Adults

Completed Last updated 26 March 2025

What this trial tests

trial in Long COVID in 400 participants. Completed in 25 November 2024.

Timeline

10 August 2022

Primary endpoint
30 October 2024

25 November 2024

Quick facts

Lead sponsor	University of Witwatersrand, South Africa
Status	Completed
Study type	OBSERVATIONAL
Enrollment	400
Start date	10 August 2022
Primary completion	30 October 2024
Estimated completion	25 November 2024
Sites	2 locations across South Africa

Conditions studied

• Long COVID — all drugs for Long COVID →

Sponsor

University of Witwatersrand, South Africa

Who can join

Adults 18 to 100, any sex, with Long COVID. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

"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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.