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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19; Quality of Life; Disability Physical; Disabilities Mental
• Intervention / Treatment: Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.

• Study Type: Observational
• Enrollment (Actual): 1085

Contacts and Locations

Study Locations

• Brazil
  • AC
    • Rio Branco, AC, Brazil
      • Clínica Silvestre Santé
  • ES
    • Vitória, ES, Brazil
      • Hospital Enseada Prime
  • MG
    • Belo Horizonte, MG, Brazil
      • Hospital Metropolitano Célio de Castro
    • Belo Horizonte, MG, Brazil
      • Instituto Horizonti
  • MS
    • Campo Grande, MS, Brazil
      • Hospital do Coração do Mato Grosso do Sul
  • PR
    • Ponta Grossa, PR, Brazil
      • Hospital universitário de Ponta Grossa
  • RS
    • Porto Alegre, RS, Brazil
      • Hospital Vila Nova
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital Moinhos de Vento
  • SC
    • Joinville, SC, Brazil
      • Instituto Procardio
  • SP
    • Itapetininga, SP, Brazil
      • Hospital Leo Orsi
    • Ribeirão Preto, SP, Brazil
      • Hospital de Clínicas de Ribeirão Preto
    • São Paulo, SP, Brazil
      • Hospital Alemao Oswaldo Cruz
    • São Paulo, SP, Brazil
      • Hospital Santa Paula
    • São Paulo, SP, Brazil
      • Hospital do Coracao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients survivors with proven mild symptomatic COVID-19 disease not requiring hospitalization.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with mild COVID-19; Patients with symptomatic COVID-19 disease not requiring hospitalization.	Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.; Patients with symptomatic COVID-19 disease not requiring hospitalization.

What is the study measuring?

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 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.
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 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.
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 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.
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.

Collaborators and Investigators

• Sponsor: Hospital Moinhos de Vento
• Investigators: Principal Investigator: Regis Rosa, MD, PhD, Hospital Moinhos de Vento

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2022
• Primary Completion (Estimated): December 20, 2023
• Study Completion (Estimated): July 20, 2024

Study Registration Dates

• First Submitted: January 14, 2022
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: Pos-COVID Brasil 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No