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

November 3, 2023 updated by: Hospital Moinhos de Vento
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1085

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients survivors with proven mild symptomatic COVID-19 disease not requiring hospitalization.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with mild COVID-19
Patients with symptomatic COVID-19 disease not requiring hospitalization.
Other: Patients with symptomatic COVID-19 disease not requiring hospitalization.
Patients with symptomatic COVID-19 disease not requiring hospitalization.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
One-year utility score of health related quality of life
Time Frame: The outcome will be assessed 12 months after enrollment.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Utility score of health related quality of life at 3, 6, and 9 months
Time Frame: The outcome will be assessed at 3, 6, and 9 months after enrollment.
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.
Incidence of major cardiovascular events
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Prevalence of cognitive dysfunction
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Prevalence of anxiety and depression symptoms
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Prevalence of posttraumatic stress disorder symptoms
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Physical functional status
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Instrumental Activities of Daily Living
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Incidence of new symptomatic COVID-19 infection
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.
Incidence of all-cause mortality
Time Frame: The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Incidence of all-cause mortality
The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Incidence of hospitalizations
Time Frame: The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Incidence of all-cause hospitalizations
The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
Prevalence of prolonged COVID-19 symptoms
Time Frame: The outcome will be assessed at 1, 3, 6, 9, and 12 months after enrollment.
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.
Incidence of return to work or study
Time Frame: The outcome will be assessed at 3, 6, 9, and 12 months after enrollment.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Moinhos de Vento

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Regis Rosa, MD, PhD, Hospital Moinhos de Vento

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 25, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pos-COVID Brasil 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The authors encourage interested parties to contact the corresponding author with data sharing requests, including for access to additional unpublished data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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