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NCT05445713Befejeződött

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

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

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 26.

Következő lépések

Rövid összefoglaló (regiszter, angolul)

"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.

Állapot (regiszter)
Befejeződött
Vizsgálattípus
Megfigyeléses
Résztvevők száma
400 (tényleges)
Első benyújtás
2022. júl. 4.
Kezdés
2022. aug. 10.
Elsődleges befejezés
2024. okt. 30.
Fő szponzor
University of Witwatersrand, South Africa
NCT-szám
NCT05445713

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Bevont résztvevők: 400
  • 2022. aug. 10. és az elsődleges befejezés (2024. okt. 30.) között
  • 2 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • 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].

Más betegség

  • COVID-19 within three months of the baseline visit.
  • 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.

Egyéb

  • 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.
  • 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.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (2)

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HelyszínVárosOrszágHelyszín állapota
Sunnyside Office ParkJohannesburgDél-afrikai KöztársaságIsmeretlen állapot
Charlotte Maxeke Johannesburg Academic Hospital (CMJAH)JohannesburgDél-afrikai KöztársaságIsmeretlen állapot

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