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NCT Number: NCT05822193

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

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.

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Key information

Conditions

Post-Acute COVID-19 Syndrome COVID-19 Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inova Medical

Cachoeirinha, Rio Grande do Sul, Brazil

Location status: Recruiting

Location contact

Maicon Falavigna

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multiple exposures

Other

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 outcomes

  1. Post COVID-19 condition according to the WHO definition

    Time frame: 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

  2. EQ5D-3L

    Time frame: 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 outcomes

  1. Instrumental activities of daily living

    Time frame: 3 to 24 months

    Instrumental activities of daily living assessed with the Lawton & Brody Instrumental Activities of Daily Living

  2. Functional status

    Time frame: 3 to 24 months

    Functional status assessed with the Modified Barthel Index

  3. Cognition

    Time frame: 3 to 24 months

    Cognition assessed with the Telephone Interview for Cognitive Status

  4. Anxiety symptoms

    Time frame: 3 to 24 months

    Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;

  5. Depression symptoms

    Time frame: 3 to 24 months

    Depression symptoms assessed with the Hospital Anxiety and Depression Scale;

  6. Posttraumatic stress symptoms

    Time frame: 3 to 24 months

    Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised

  7. Time to return to work or studies

    Time frame: 3 to 24 months

    Time to return to work or studies after COVID-19

  8. Healthcare utilization

    Time frame: 3 to 24 months

    Medical and rehabilitation appointments, medication use and diagnostic tests

  9. Costs

    Time frame: 3 to 24 months

    Individual health-related and COVID-19-related costs

Study contacts

Contact information is provided by the study sponsor or research team.

Maicon Falavigna, MD, PhD

CONTACT

[email protected]

+5551994408818

Régis G Rosa, MD, PhD

CONTACT

[email protected]

+5551991303877

Sponsors and collaborators

Lead sponsor

Inova Medical

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2023
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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