Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil

Hospital Moinhos de Vento14 sites in 1 country1,085 target enrollmentJanuary 25, 2022

ConditionsCOVID-19 Quality of Life Disability Physical Disabilities Mental

Overview

Phase: N/A
Intervention: Not specified
Conditions: COVID-19
Sponsor: Hospital Moinhos de Vento
Enrollment: 1085
Locations: 14
Primary Endpoint: One-year utility score of health related quality of life
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 25, 2022

End Date

July 20, 2024

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hospital Moinhos de Vento

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

One-year utility score of health related quality of life

Time Frame: The outcome will be assessed 12 months after enrollment.

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).

Secondary Outcomes

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.)
Prevalence of anxiety and depression symptoms(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 posttraumatic stress disorder symptoms(The outcome will be assessed at 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 new symptomatic COVID-19 infection(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
Incidence of return to work or study(The outcome will be assessed at 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.)
Prevalence of cognitive dysfunction(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
Physical functional status(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)
Instrumental Activities of Daily Living(The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.)