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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05165979
Other study ID # Pos-COVID Brasil 1
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 21, 2021
Est. completion date July 1, 2024

Study information

Verified date November 2023
Source Hospital Moinhos de Vento
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 650
Est. completion date July 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Hospitalization due to COVID-19
Hospitalization due to COVID-19

Locations

Country Name City State
Brazil Hospital das clínicas da UFMG Belo Horizonte MG
Brazil Hospital Emydio Germano Belo Horizonte MG
Brazil Hospital Metropolitano Célio de Castro Belo Horizonte MG
Brazil Instituto Horizonti Belo Horizonte MG
Brazil Hospital do Coração de Mato Grosso do Sul Campo Grande MS
Brazil Hospital Universitário de Canoas Canoas RS
Brazil Santa Casa de Curitiba Curitiba PR
Brazil Hospital Nelson Cornetet Guaíba RS
Brazil Hospital Leo Orsi Itapetininga SP
Brazil Hospital Universitário de Londrina Londrina PR
Brazil Hospital das Clínicas de Passo Fundo Passo Fundo RS
Brazil Hospital São Vicente de Paulo Passo Fundo RS
Brazil Hospital universitário de Ponta Grossa Ponta Grossa PR
Brazil Fundação Universitária Instituto de Cardiologia Porto Alegre RS
Brazil Hospital de Clínicas de Porto Alegre Porto Alegre RS
Brazil Hospital Ernesto Dornelles Porto Alegre RS
Brazil Hospital moinhos de Vento Porto Alegre Rio Grande Do Sul
Brazil Hospital Vila Nova Porto Alegre RS
Brazil Cemetron Porto Velho RO
Brazil Hospital Beneficência Portuguesa de Ribeirão Preto Ribeirão Preto SP
Brazil Hospital Alemão Oswaldo Cruz São Paulo SP
Brazil Hospital Beneficência Portuguesa de São Paulo São Paulo SP
Brazil Hospital do Coração São Paulo SP
Brazil Hospital SEPACO São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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.
Secondary Incidence of all-cause mortality Incidence of all-cause mortality The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Secondary 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.
Secondary Incidence of rehospitalizations Incidence of all-cause rehospitalizations The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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