Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From COVID-19. (FUNCTION)

August 28, 2022 updated by: Universidad Peruana Cayetano Heredia

FUNCTION Study: Follow- Up Study iN SARS-CoV-2 infecTION. Long-term Impact on Cardiopulmonary Function and Quality of Life in Patients Recovered From SARS-CoV-2 Infection in Lima, Peru

FUNCTION is an observational cohort study conducted by researchers from the Instituto de Medicina Tropical Alexander von Humboldt at Universidad Peruana Cayetano Heredia and Cayetano Heredia Hospital.

The overall aim is to asses the long-term impact of SARS-CoV-2 infection on the cardiopulmonary function and quality of life in patients recovered from COVID-19, through a 6-month follow-up structured in 4 visits with clinical assessments and imaging studies performed by specialists.

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.
162

Contacts and Locations

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

Study Locations

  • Peru
    • Lima
      • Lima Lima, Lima, Peru
        • Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inpatients will be screened and recruited mainly from Cayetano Heredia Hospital, a tertiary-level referral center with an assigned population of nearly 3 million individuals. Also patients admitted into different public or private institutions in Lima could be considered.

Outpatients will be screened and recruited from primary level health care centers located in different parts of Lima.

Description

Inclusion Criteria:

  • Individuals must meet all of the following criteria (either for group A or B) in order to participate in the study:

    • Individuals of any sex over 18 years of age
    • A positive COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques within the last 14 days prior the enrollment. A laboratory-based confirmatory report will be required
    • Recruitment time close around the discharge date or no longer than 7 days after discharge
    • Group A: Individuals who had not reported signs or symptoms suggestive of COVID-19 infection
    • Group B: Individuals who had reported signs or symptoms suggestive of COVID-19 infection

Exclusion Criteria:

  • An individual meeting any of the following criteria at the time of enrollment will be excluded from study participation:

    • A negative COVID-19 test result by nasopharyngeal swab for either RT-PCR or antigenic techniques
    • Known inability to keep adherent to the study (ex. incarceration, migration, travel)
    • Active pregnancy confirmed by either qualitative urine or quantitative blood beta-hCG test

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

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.
Group A (asymptomatic infection)
Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge.
Other: None intervation
Observational Study
Group B1 (mild symptomatic infection)
Clinical manifestation of the infection without severity signs (respiratory rate < 30/minute; peripheral oxygen saturation (SpO2) >94%) and no radiological evidence of pneumonia
Other: None intervation
Observational Study
Group B2 (moderate symptomatic infection)
Clinical manifestation of the infection without severity signs (respiratory rate < 30/minute; peripheral oxygen saturation (SpO2) >94%) and radiological evidence of pneumonia
Other: None intervation
Observational Study
Group B3 (severe symptomatic infection)
Clinical manifestation of the infection with severity signs (respiratory rate > 30/minute; peripheral oxygen saturation (SpO2) <94%) and radiological evidence of pneumonia
Other: None intervation
Observational Study
Group B4 (critical symptomatic infection)

Clinical manifestation of the infection with severity signs (respiratory rate > 30/minute; peripheral oxygen saturation (SpO2) <94%) and at least one of the following:

I) Acute Respiratory Distress Syndrome: defined under Berlin Criteria mostly defined by a PaFi<200, II) Shock: Patient diagnosed with sepsis that despite adequate fluid resuscitation, require vasopressors to maintain a mean arterial pressure ≥65 mmHg and lactate values >2 mmol/L (>18 mg/dL) or III) Organ dysfunction that requires ICU admission
Other: None intervation
Observational Study

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
Abnormal pulmonary function
Time Frame: 6 months
% of participants with carbon monoxide diffusing capacity lower than 80 percent of predicted at each study visit. The dependent variable will be categorized as dichotomic variable for subsequent analysis
6 months
Abnormal cardiovascular function
Time Frame: 6 months
LVEF<50% will be considered an abnormal cardiovascular function test. The dependent variable will be categorized as dichomotoic variables for subsequent analysis.
6 months
Abnormal quality of life
Time Frame: 6 months
Health-related quality of life, Medical Outcomes Study short-form (SF-36) at each visit assessed using the Short Form-36 (SF-36). The SF-36 scale consists of 8 dimensions which is subsequently converted into a percentage score. The dependent variable will be categorized as dichotomic variable for subsequent analysis.
6 months

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.
Universidad Peruana Cayetano Heredia

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: Rodrigo A Cachay, MD, Universidad Peruana Cayetano Heredia

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

Helpful Links

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.
August 7, 2021

Primary Completion (Anticipated)

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.
October 1, 2022

Study Completion (Anticipated)

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.
October 1, 2022

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).
May 9, 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.
May 19, 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.
May 23, 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.
August 30, 2022

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.
August 28, 2022

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.
May 1, 2022

More Information

Terms related to this study

Keywords

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.
  • SIDISI 203725
  • IN-US-983-6130 (Other Grant/Funding Number: Gilead Sciences)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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