Post-Acute COVID-19 Syndrome
Conditions
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.
Interventions
OTHERMultiple 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.
Sponsors
Merck Sharp & Dohme LLC
Inova Medical
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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; |
| Instrumental activities of daily living | 3 to 24 months | Instrumental activities of daily living assessed with the Lawton & Brody Instrumental Activities of Daily Living |
| 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 |
| Posttraumatic stress symptoms | 3 to 24 months | Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised |
| Functional status | 3 to 24 months | Functional status assessed with the Modified Barthel Index |
Countries
Brazil
Contacts
Primary ContactMaicon Falavigna, MD, PhD
Backup ContactRégis G Rosa, MD, PhD
Outcome results
None listed