An observational study in Post-Acute COVID-19 Syndrome, sponsored by Inova Medical. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-19.
Sponsored by Inova Medical · Observational
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 1,694 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Inova Medical is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study target population is composed by adult participants with confirmed symptomatic COVID-19 during the SARS-CoV-2 omicron wave in Brazil (January 2022 to date, representing the period of time with absolute dominance of omicron as circulating variant). The study will include patients with distinct levels of acute illness severity (i.e., both outpatients and patients who required hospitalization for COVID-19).
Exclusion Criteria:
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.
Post COVID-19 condition according to the WHO definition
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
Time frame: 3 to 24 months
EQ5D-3L
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.
Time frame: 3 to 24 months
Instrumental activities of daily living
Instrumental activities of daily living assessed with the Lawton \& Brody Instrumental Activities of Daily Living
Time frame: 3 to 24 months
Functional status
Functional status assessed with the Modified Barthel Index
Time frame: 3 to 24 months
Cognition
Cognition assessed with the Telephone Interview for Cognitive Status
Time frame: 3 to 24 months
Anxiety symptoms
Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;
Time frame: 3 to 24 months
Depression symptoms
Depression symptoms assessed with the Hospital Anxiety and Depression Scale;
Time frame: 3 to 24 months
Posttraumatic stress symptoms
Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised
Time frame: 3 to 24 months
Time to return to work or studies
Time to return to work or studies after COVID-19
Time frame: 3 to 24 months
Healthcare utilization
Medical and rehabilitation appointments, medication use and diagnostic tests
Time frame: 3 to 24 months
Costs
Individual health-related and COVID-19-related costs
Time frame: 3 to 24 months
Plan to share: Undecided — To be disclosed
No publications or documents are linked to this record.
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