Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
1 other identifier
observational
1,085
1 country
14
Brief Summary
The present prospective cohort study aims to assess factors associated with of one-year health-related quality of life and physical, cognitive and mental health outcomes among adult patients with mild COVID-19. Adult patients with symptomatic COVID-19 not requiring hospitalization will be followed through structured and centralized telephone interviews performed at 1, 3, 6, 9 and 12 months after enrollment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Typical duration for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2022
CompletedFirst Posted
Study publicly available on registry
January 19, 2022
CompletedStudy Start
First participant enrolled
January 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2024
CompletedNovember 7, 2023
January 1, 2023
1.9 years
January 14, 2022
November 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
One-year utility score of health related quality of life
The outcome will be assessed using the Brazilian version of the Euroqol-5D-3L (EQ-5D3L) questionnaire. The utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).
The outcome will be assessed 12 months after enrollment.
Secondary Outcomes (12)
Utility score of health related quality of life at 3, 6, and 9 months
The outcome will be assessed at 3, 6, and 9 months after enrollment.
Incidence of all-cause mortality
The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Incidence of major cardiovascular events
The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Incidence of hospitalizations
The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Prevalence of prolonged COVID-19 symptoms
The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
- +7 more secondary outcomes
Study Arms (1)
Patients with mild COVID-19
Patients with symptomatic COVID-19 disease not requiring hospitalization.
Interventions
Patients with symptomatic COVID-19 disease not requiring hospitalization.
Eligibility Criteria
Adult patients survivors with proven mild symptomatic COVID-19 disease not requiring hospitalization.
You may qualify if:
- Age ≥18 years;
- Positive polymerase chain reaction (PCR) test for SARS-CoV-2;
- At least one of the following symptoms: fever, cough, sneezing, dyspnea, fatigue, smell alteration, rhinorrhea, sore throat, myalgia, arthralgia, diarrhea;
- Outpatient COVID-19 care at the moment of enrollment (without indication for in-hospital care).
You may not qualify if:
- Severe comorbidity with life expectancy less than 3 months;
- Absence of proxy for patients with communication difficulties;
- Absence of telephone contact;
- Refusal or withdrawal of agreement to participate;
- Previous enrollment in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Clinica Silvestre Santé
Rio Branco, Acre, Brazil
Hospital Enseada Prime
Vitória, Espírito Santo, Brazil
Hospital do Coração do Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul, Brazil
Hospital Metropolitano Célio de Castro
Belo Horizonte, Minas Gerais, Brazil
Instituto Horizonti
Belo Horizonte, Minas Gerais, Brazil
Hospital Universitário de Ponta Grossa
Ponta Grossa, Paraná, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Vila Nova
Porto Alegre, Rio Grande do Sul, Brazil
Instituto Procardio
Joinville, Santa Catarina, Brazil
Hospital Leo Orsi
Itapetininga, São Paulo, Brazil
Hospital de Clínicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital Alemão Oswaldo Cruz
São Paulo, São Paulo, Brazil
Hospital do Coração
São Paulo, São Paulo, Brazil
Hospital Santa Paula
São Paulo, São Paulo, Brazil
Related Publications (1)
Rover MM, Trott G, Scolari FL, Silva MMDD, Souza D, Santos RDRMD, Dagnino APA, Mesquita Neto J, Estivalete GP, Kozesinski-Nakatani AC, Marcolino MS, Barreto BB, Schvartzman PR, Antonio ACP, Robinson CC, Falavigna M, Biolo A, Polanczyk CA, Rosa RG. Health-Related Quality of Life and Long-Term Outcomes after Mildly Symptomatic COVID-19: The Post-COVID Brazil Study 2 Protocol. Arq Bras Cardiol. 2023 Sep;120(9):e20220835. doi: 10.36660/abc.20220835. English, Portuguese.
PMID: 37851732BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Regis Rosa, MD, PhD
Hospital Moinhos de Vento
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2022
First Posted
January 19, 2022
Study Start
January 25, 2022
Primary Completion
December 20, 2023
Study Completion
July 20, 2024
Last Updated
November 7, 2023
Record last verified: 2023-01