NCT05822193

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,694

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

July 21, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

April 18, 2023

Last Update Submit

February 17, 2025

Conditions

Post-Acute COVID-19 Syndrome

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    3 to 24 months

Secondary Outcomes (9)

  • Instrumental activities of daily living

    3 to 24 months

  • Functional status

    3 to 24 months

  • Cognition

    3 to 24 months

  • Anxiety symptoms

    3 to 24 months

  • Depression symptoms

    3 to 24 months

  • +4 more secondary outcomes

Study Arms (1)

Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil

Other: Multiple exposures

Interventions

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.

Individuals with COVID-19 diagnosis during the SARS-CoV-2 omicron wave in Brazil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • No availability to participate in remote research appointments;
  • Communication difficulty (aphasia, important hearing loss, non-portuguese speaker, severe dementia)
  • Refuse to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inova Medical

Cachoeirinha, Rio Grande do Sul, Brazil

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Maicon Falavigna, MD, PhD

CONTACT

+5551994408818maicon@inovamedical.com.br

Régis G Rosa, MD, PhD

CONTACT

+5551991303877regis@inovamedical.com.br

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 20, 2023

Study Start

July 21, 2023

Primary Completion

July 1, 2025

Study Completion

July 31, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

BR(1)