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Recruiting NCT05822193

Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil

— Observational Post-Acute COVID-19 Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Multiple exposures.
Who it may be relevant to
Registry conditions: Post-Acute COVID-19 Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a national retrospective cohort study with internet-based recruitment which intends to enroll 1,694 adult patients with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil. Participants with confirmed symptomatic COVID-19 after january 2022 will be evaluated in order to assess incidence, potential risk factors and impact of post COVID-19 condition according to the WHO definition on health-related quality of life and other relevant patient-centered outcomes.

Interventions

  • Other Multiple exposures
    Exposures variables (observational study): age, gender, education, comorbidities, vaccination status, severity of the acute episode of COVID-19, treatments used for acute COVID-19.

Primary outcome measures

  • Post COVID-19 condition according to the WHO definition [Time frame: 3 to 24 months]
  • EQ5D-3L [Time frame: 3 to 24 months]
Secondary outcome measures (9)
  • Instrumental activities of daily living [Time frame: 3 to 24 months]
  • Functional status [Time frame: 3 to 24 months]
  • Cognition [Time frame: 3 to 24 months]
  • Anxiety symptoms [Time frame: 3 to 24 months]
  • Depression symptoms [Time frame: 3 to 24 months]
  • Posttraumatic stress symptoms [Time frame: 3 to 24 months]
  • Time to return to work or studies [Time frame: 3 to 24 months]
  • Healthcare utilization [Time frame: 3 to 24 months]
  • Costs [Time frame: 3 to 24 months]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years;
  • Brazilian resident;
  • Symptomatica COVID-19 confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) or antigen test for SARS-COV-2 after January 2022, with diagnosis at least 90 days before recruitment.

Exclusion criteria

  • No availability to participate in remote research appointments;
  • Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
  • Refuse to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Inova Medical — Cachoeirinha

Identifiers

NCT: NCT05822193 · 2023/001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗