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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05197647
• Other study ID #: Pos-COVID Brasil 2
• Status: Active, not recruiting
• Start date: January 25, 2022
• Est. completion date: July 20, 2024

Study information

• Verified date: January 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1085
• Est. completion date: July 20, 2024
• Est. primary completion date: December 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Patients with symptomatic COVID-19 disease not requiring hospitalization.
Patients with symptomatic COVID-19 disease not requiring hospitalization.

Locations

Country	Name	City	State
Brazil	Hospital Metropolitano Célio de Castro	Belo Horizonte	MG
Brazil	Instituto Horizonti	Belo Horizonte	MG
Brazil	Hospital do Coração do Mato Grosso do Sul	Campo Grande	MS
Brazil	Hospital Leo Orsi	Itapetininga	SP
Brazil	Instituto Procardio	Joinville	SC
Brazil	Hospital Universitário de Ponta Grossa	Ponta Grossa	PR
Brazil	Hospital Moinhos de Vento	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital Vila Nova	Porto Alegre	RS
Brazil	Hospital de Clínicas de Ribeirão Preto	Ribeirão Preto	SP
Brazil	Clinica Silvestre Santé	Rio Branco	AC
Brazil	Hospital Alemão Oswaldo Cruz	São Paulo	SP
Brazil	Hospital do Coração	São Paulo	SP
Brazil	Hospital Santa Paula	São Paulo	SP
Brazil	Hospital Enseada Prime	Vitória	ES

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Moinhos de Vento

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

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 utility score derived from the EQ5D-3L ranges from 0 (death) to 1 (perfect health).	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 1, 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 hospitalizations	Incidence of all-cause hospitalizations	The outcome will be assessed at 1, 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 1, 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 COVID-19 diagnosis.	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.