Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe 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 survivors of hospitalization for COVID-19. Adult patients requiring hospitalization due to COVID-19 disease will be followed through structured and centralized telephone interviews performed at 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: Hospitalization due to COVID-19

• Study Type: Observational
• Enrollment (Actual): 650

Contacts and Locations

• Study Contact: Name: Geraldine Trott, PhD; Phone Number: +5551994407117; Email: geraldine.trott@hmv.org.br

Study Locations

• Brazil
  • MG
    • Belo Horizonte, MG, Brazil
      • Hospital Metropolitano Célio de Castro
    • Belo Horizonte, MG, Brazil
      • Instituto Horizonti
    • Belo Horizonte, MG, Brazil
      • Hospital Das Clinicas Da Ufmg
    • Belo Horizonte, MG, Brazil
      • Hospital Emydio Germano
  • MS
    • Campo Grande, MS, Brazil
      • Hospital do Coração de Mato Grosso do Sul
  • PR
    • Curitiba, PR, Brazil
      • Santa Casa de Curitiba
    • Londrina, PR, Brazil
      • Hospital Universitário de Londrina
    • Ponta Grossa, PR, Brazil
      • Hospital universitário de Ponta Grossa
  • RO
    • Porto Velho, RO, Brazil
      • Cemetron
  • RS
    • Canoas, RS, Brazil
      • Hospital Universitário de Canoas
    • Guaíba, RS, Brazil
      • Hospital Nelson Cornetet
    • Passo Fundo, RS, Brazil
      • Hospital São Vicente de Paulo
    • Passo Fundo, RS, Brazil
      • Hospital das Clinicas de Passo Fundo
    • Porto Alegre, RS, Brazil
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, RS, Brazil
      • Hospital Vila Nova
    • Porto Alegre, RS, Brazil
      • Fundação Universitária Instituto de Cardiologia
    • Porto Alegre, RS, Brazil
      • Hospital Ernesto Dornelles
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil
      • Hospital Moinhos de Vento
  • SP
    • Itapetininga, SP, Brazil
      • Hospital Leo Orsi
    • Ribeirão Preto, SP, Brazil
      • Hospital Beneficência Portuguesa de Ribeirão Preto
    • São Paulo, SP, Brazil
      • Hospital Alemao Oswaldo Cruz
    • São Paulo, SP, Brazil
      • Hospital do Coracao
    • São Paulo, SP, Brazil
      • Hospital Beneficencia Portuguesa de Sao Paulo
    • São Paulo, SP, Brazil
      • Hospital SEPACO

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 of hospitalization due to proven COVID-19 disease.

Description

Inclusion Criteria:

• Age ≥18 years;
• Symptomatic COVID-19 disease within the last 14 days;
• Positive polymerase chain reaction (PCR) test for SARS-CoV-2 within the last 14 days;
• Need of hospitalization (duration ≥ 48 hours).

Exclusion Criteria:

• Severe comorbidity with life expectancy less than 3 months;
• Death during hospitalization;
• Absence of telephone contact;
• Absence of proxy for patients with communication difficulties;
• Refusal or withdrawal of agreement to participate;
• Previous enrollment in the study.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hospitalized COVID-19 patients	Other: Hospitalization due to COVID-19; Hospitalization due to COVID-19

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 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 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 rehospitalizations	Incidence of all-cause rehospitalizations	The outcome will be assessed at 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 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 hospitalization.	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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

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

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
• product manufactured in and exported from the U.S.: No