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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05165979
• Other study ID #: Pos-COVID Brasil 1
• Status: Active, not recruiting
• 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
• 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.

Related Conditions & MeSH terms

• COVID-19
• Disabilities Mental
• Disability Physical
• Quality of Life

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.