Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
ConditionPost-Acute COVID-19 Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInova Medical
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
No availability to participate in remote research appointments;
Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
Refuse to provide informed consent
Trial population
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).
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Multiple exposures
Other interventionExposures variables (observational study): age, gender, education, comorbidities, vaccination status, severity of the acute episode of COVID-19, treatments used for acute COVID-19.
Treatment groups
1,694 Participants
are divided into 1 treatment groupGroup A: Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
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 months2
Functional status
Functional status assessed with the Modified Barthel Index
Time frame
3 to 24 months3
Cognition
Cognition assessed with the Telephone Interview for Cognitive Status
Time frame
3 to 24 months4
Anxiety symptoms
Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;
Time frame
3 to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Inova Medical
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
Source ClinicalTrials.gov