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

NCT ID: NCT05197647

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1085 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-25

Study Completion Date

2024-07-20

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Quality of Life Disability Physical Disabilities Mental

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with mild COVID-19

Patients with symptomatic COVID-19 disease not requiring hospitalization.

Patients with symptomatic COVID-19 disease not requiring hospitalization.

Intervention Type OTHER

Patients with symptomatic COVID-19 disease not requiring hospitalization.

Interventions

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Patients with symptomatic COVID-19 disease not requiring hospitalization.

Patients with symptomatic COVID-19 disease not requiring hospitalization.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Moinhos de Vento

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Regis Rosa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Moinhos de Vento

Locations

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Clinica Silvestre Santé

Rio Branco, Acre, Brazil

Site Status

Hospital Enseada Prime

Vitória, Espírito Santo, Brazil

Site Status

Hospital do Coração do Mato Grosso do Sul

Campo Grande, Mato Grosso do Sul, Brazil

Site Status

Hospital Metropolitano Célio de Castro

Belo Horizonte, Minas Gerais, Brazil

Site Status

Instituto Horizonti

Belo Horizonte, Minas Gerais, Brazil

Site Status

Hospital Universitário de Ponta Grossa

Ponta Grossa, Paraná, Brazil

Site Status

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Hospital Vila Nova

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto Procardio

Joinville, Santa Catarina, Brazil

Site Status

Hospital Leo Orsi

Itapetininga, São Paulo, Brazil

Site Status

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Hospital Alemão Oswaldo Cruz

São Paulo, São Paulo, Brazil

Site Status

Hospital do Coração

São Paulo, São Paulo, Brazil

Site Status

Hospital Santa Paula

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND
PMID: 37851732 (View on PubMed)

Other Identifiers

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Pos-COVID Brasil 2

Identifier Type: -

Identifier Source: org_study_id

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