Clinical trial NCT05197647: Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
Official title: Cohort Study for the Assessment of Long-term Impact of COVID-19 Among Mild COVID-19 Patients in Brazil
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Quality of Life
Disability Physical
Disabilities Mental
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 1085
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 with proven mild symptomatic COVID-19 disease not requiring hospitalization.

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 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.


Eligibility criteria: 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.

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 1, 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 hospitalizations
timeFrame: The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
measure: Prevalence of prolonged COVID-19 symptoms
timeFrame: The outcome will be assessed at 1, 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: Rio Branco
country: Brazil
facility: Clinica Silvestre Santé
state: AC
city: Vitória
country: Brazil
facility: Hospital Enseada Prime
state: ES
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 do Mato Grosso do Sul
state: MS
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 Alegre
country: Brazil
facility: Hospital Vila Nova
state: RS
city: Joinville
country: Brazil
facility: Instituto Procardio
state: SC
city: Itapetininga
country: Brazil
facility: Hospital Leo Orsi
state: SP
city: Ribeirão Preto
country: Brazil
facility: Hospital de Clínicas de Ribeirão Preto
state: SP
city: São Paulo
country: Brazil
facility: Hospital Alemão Oswaldo Cruz
state: SP
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
city: São Paulo
country: Brazil
facility: Hospital Santa Paula
state: SP
Study officials:
affiliation: Hospital Moinhos de Vento
name: Regis Rosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.