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

Study Overview
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Brief Summary
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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.

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

Conditions
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COVID-19, Quality of Life, Disability Physical, Disabilities Mental

Intervention / Treatment
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* Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with mild COVID-19<br>Patients with symptomatic COVID-19 disease not requiring hospitalization. | Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.<br>* Patients with symptomatic COVID-19 disease not requiring hospitalization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility score of health related quality of life at 3, 6, and 9 months | 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 at 3, 6, and 9 months after enrollment. | 
| Incidence of all-cause mortality | 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 | Incidence of major cardiovascular events (composite endpoint of non-fatal stroke, non-fatal acute myocardial infarction, or cardiovascular death) | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Incidence of hospitalizations | Incidence of all-cause hospitalizations | The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. | 
| Prevalence of prolonged COVID-19 symptoms | Prevalence of prolonged COVID-19 symptoms defined as presence of dyspnea, cough, fatigue, muscular weakness, chest discomfort, joint pain, anosmia, hair loss, brain fog, insomnia, among others) | The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment. | 
| Prevalence of cognitive dysfunction | Prevalence of cognitive dysfunction as assessed by the Telephone Interview for Cognitive Status (TICS-m; scores ranging from 0 to 50 with lower scores indicating worse cognition). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Prevalence of anxiety and depression symptoms | Prevalence of anxiety and depression symptoms as assessed by the Hospital Anxiety and Depression Scale (anxiety and depression scores range from 0 to 21, with higher scores indicating worse symptoms). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Prevalence of posttraumatic stress disorder symptoms | Prevalence of posttraumatic stress disorder symptoms as assessed by the Impact Event Scale-6 (scores range from 0 to 24 with higher scores indicating worse symptoms). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Physical functional status | Physical functional status as assessed by the modified Barthel index (score ranges from 0 to 100; higher scores indicate less functional dependence). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Instrumental Activities of Daily Living | The outcome will be assessed using the Lawton & Brody Instrumental Activities of Daily Living Scale (the score ranges from 0 to 8, with higher scores indicating less dependence). | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Incidence of return to work or study | Incidence of return to work or study among patients that were working or studying at the moment of COVID-19 diagnosis. | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. | 
| Incidence of new symptomatic COVID-19 infection | Incidence of new symptomatic COVID-19 infection defined as recurrence of COVID-19-related symptoms with a positive PCR test for SARS-CoV-2 90 days after the index infection. | The outcome will be assessed at 3, 6, 9, and 12 months after enrollment. |