Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil
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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.
|
Outcome Measures
Primary Outcome Measures
- Post COVID-19 condition according to the WHO definition [3 to 24 months]
Post COVID-19 condition occurs in individuals with a history of probable or confirmed SARS CoV-2 infection, usually 3 months from the onset of COVID-19 with symptoms and that last for at least 2 months and cannot be explained by an alternative diagnosis
- EQ5D-3L [3 to 24 months]
Health-related quality of life assessed using the EuroQol five-dimensional 3-level descriptive system (EQ5D-3L). This outcome will be considered as primary when Post COVID-19 condition be used as exposure.
Secondary Outcome Measures
- Instrumental activities of daily living [3 to 24 months]
Instrumental activities of daily living assessed with the Lawton & Brody Instrumental Activities of Daily Living
- Functional status [3 to 24 months]
Functional status assessed with the Modified Barthel Index
- Cognition [3 to 24 months]
Cognition assessed with the Telephone Interview for Cognitive Status
- Anxiety symptoms [3 to 24 months]
Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;
- Depression symptoms [3 to 24 months]
Depression symptoms assessed with the Hospital Anxiety and Depression Scale;
- Posttraumatic stress symptoms [3 to 24 months]
Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised
- Time to return to work or studies [3 to 24 months]
Time to return to work or studies after COVID-19
- Healthcare utilization [3 to 24 months]
Medical and rehabilitation appointments, medication use and diagnostic tests
- Costs [3 to 24 months]
Individual health-related and COVID-19-related costs
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥ 18 years;
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Brazilian resident;
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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:
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No availability to participate in remote research appointments;
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Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
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Refuse to provide informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Inova Medical
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023/001