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

Recruiting

• Conditions: Post-Acute COVID-19 Syndrome
• Interventions: Other: Multiple exposures

• Registration Number: NCT05822193
• Lead Sponsor: Inova Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-18
• Study First Submitted QC: 2023-04-18
• Study First Posted: 2023-04-20
• Study Start: 2023-07-21
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-17
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1694

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil	Multiple exposures	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Depression symptoms	3 to 24 months	Depression symptoms assessed with the Hospital Anxiety and Depression Scale;
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
Time to return to work or studies	3 to 24 months	Time to return to work or studies after COVID-19
Costs	3 to 24 months	Individual health-related and COVID-19-related costs
Instrumental activities of daily living	3 to 24 months	Instrumental activities of daily living assessed with the Lawton \& Brody Instrumental Activities of Daily Living
Posttraumatic stress symptoms	3 to 24 months	Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised
Anxiety symptoms	3 to 24 months	Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;
Healthcare utilization	3 to 24 months	Medical and rehabilitation appointments, medication use and diagnostic tests

Trial Locations

Locations (1)

Inova Medical; 🇧🇷 Cachoeirinha, RS, Brazil