Post-Acute COVID-19 SyndromeNCT05822193
Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
An observational study of Post-Acute COVID-19 Syndrome, run by Inova Medical at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Acute COVID-19 Syndrome
- What is being tested?
- Multiple exposures
- Type of treatment
- Vaccines
- How many people
- 1,694 participants
- Where
- 1 siteBrazil
- Study dates
- 21 Jul 2023to 31 Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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).
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Inova Medical
Cachoeirinha, Rio Grande do Sul
Maicon Falavigna
About this study
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.
- Conditions
- Post-Acute COVID-19 Syndrome
- Being tested
- Multiple exposures
- Medical subject headings
- Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiple exposuresOther
Exposures variables (observational study): age, gender, education, comorbidities, vaccination status, severity of the acute episode of COVID-19, treatments used for acute COVID-19.
| Study group | Role | What they receive |
|---|---|---|
| Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil | Not described Receives: Other: Multiple exposures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 3 to 24 months
Secondary outcomes (9)
Instrumental activities of daily living
Instrumental activities of daily living assessed with the Lawton \& Brody Instrumental Activities of Daily Living
Measured: 3 to 24 months
Functional status
Functional status assessed with the Modified Barthel Index
Measured: 3 to 24 months
Cognition
Cognition assessed with the Telephone Interview for Cognitive Status
Measured: 3 to 24 months
Anxiety symptoms
Anxiety symptoms assessed with the Hospital Anxiety and Depression Scale;
Measured: 3 to 24 months
Depression symptoms
Depression symptoms assessed with the Hospital Anxiety and Depression Scale;
Measured: 3 to 24 months
Posttraumatic stress symptoms
Posttraumatic stress symptoms assessed with the Impact Event Scale-Revised
Measured: 3 to 24 months
Time to return to work or studies
Time to return to work or studies after COVID-19
Measured: 3 to 24 months
Healthcare utilization
Medical and rehabilitation appointments, medication use and diagnostic tests
Measured: 3 to 24 months
Costs
Individual health-related and COVID-19-related costs
Measured: 3 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start21 Jul 2023
- Primary completion1 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Acute COVID-19 SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,694 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Medical
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822193
- Sponsor's protocol ID
- 2023/001
- Status last verified
- Feb 2025
- First submitted
- 18 Apr 2023
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: To be disclosed
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence, Associated Factors, and Burden of Post COVID-19 Condition in Brazil
- ClinicalTrials.gov ID
- NCT05822193
- Acronym / sponsor ID
- 2023/001
- Conditions
- Post-Acute COVID-19 Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,694 participants (estimated)
- Lead sponsor
- Inova MedicalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 20 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil | – | Other: Multiple exposures |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- No availability to participate in remote research appointments;
- Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
- Refuse to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiple exposuresExposures variables (observational study): age, gender, education, comorbidities, vaccination status, severity of the acute episode of COVID-19, treatments used for acute COVID-19. | Other | Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil |
Primary outcome
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
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.
9 secondary outcomes
Instrumental activities of daily living
Time frame: 3 to 24 months
Functional status
Time frame: 3 to 24 months
Cognition
Time frame: 3 to 24 months
Anxiety symptoms
Time frame: 3 to 24 months
Depression symptoms
Time frame: 3 to 24 months
Posttraumatic stress symptoms
Time frame: 3 to 24 months
Time to return to work or studies
Time frame: 3 to 24 months
Healthcare utilization
Time frame: 3 to 24 months
Costs
Time frame: 3 to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Undecided. To be disclosed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Acute COVID-19 Syndrome, run by Inova Medical at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maicon Falavigna, MD, PhD (+5551994408818, maicon@inovamedical.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post COVID-19 condition according to the WHO definition (time frame: 3 to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.