Clinical trial NCT05165979: Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil
Official title: Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Moderate and Severe COVID-19 Patients in Brazil
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: COVID-19
Quality of Life
Disability Physical
Disabilities Mental
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients survivors of hospitalization due to proven COVID-19 disease.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: One-year utility score of health related quality of life
timeFrame: The outcome will be assessed 12 months after enrollment.
Secondary outcomes:
measure: Utility score of health related quality of life at 3, 6, and 9 months
timeFrame: The outcome will be assessed at 3, 6, and 9 months after enrollment.
measure: Incidence of all-cause mortality
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Incidence of major cardiovascular events
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Incidence of rehospitalizations
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Prevalence of prolonged COVID-19 symptoms
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Prevalence of cognitive dysfunction
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Prevalence of anxiety and depression symptoms
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Prevalence of posttraumatic stress disorder symptoms
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Physical functional status
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Instrumental Activities of Daily Living
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Incidence of return to work or study
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
measure: Incidence of new symptomatic COVID-19 infection
timeFrame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Hospital das clínicas da UFMG
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Emydio Germano
state: MG
city: Belo Horizonte
country: Brazil
facility: Hospital Metropolitano Célio de Castro
state: MG
city: Belo Horizonte
country: Brazil
facility: Instituto Horizonti
state: MG
city: Campo Grande
country: Brazil
facility: Hospital do Coração de Mato Grosso do Sul
state: MS
city: Curitiba
country: Brazil
facility: Santa Casa de Curitiba
state: PR
city: Londrina
country: Brazil
facility: Hospital Universitário de Londrina
state: PR
city: Ponta Grossa
country: Brazil
facility: Hospital universitário de Ponta Grossa
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital moinhos de Vento
state: Rio Grande Do Sul
city: Porto Velho
country: Brazil
facility: Cemetron
state: RO
city: Canoas
country: Brazil
facility: Hospital Universitário de Canoas
state: RS
city: Guaíba
country: Brazil
facility: Hospital Nelson Cornetet
state: RS
city: Passo Fundo
country: Brazil
facility: Hospital das Clínicas de Passo Fundo
state: RS
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
state: RS
city: Porto Alegre
country: Brazil
facility: Fundação Universitária Instituto de Cardiologia
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Ernesto Dornelles
state: RS
city: Porto Alegre
country: Brazil
facility: Hospital Vila Nova
state: RS
city: Itapetininga
country: Brazil
facility: Hospital Leo Orsi
state: SP
city: Ribeirão Preto
country: Brazil
facility: Hospital Beneficência Portuguesa de Ribeirão Preto
state: SP
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
state: SP
city: São Paulo
country: Brazil
facility: Hospital Beneficência Portuguesa de São Paulo
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
city: São Paulo
country: Brazil
facility: Hospital SEPACO
state: SP
Study officials:
affiliation: Hospital Moinhos de Vento
name: Regis G Rosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: