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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05386485

Acronym

FUNCTION

Enrollment

162

Registered

2022-05-23

Start date

2021-08-07

Completion date

2022-10-31

Last updated

2022-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

COVID-19, SARS-Cov-2, Cardiovascular function, Respiratory function, Life quality, Long COVID, COVID19 Sequelae, Function test

Brief summary

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.

Interventions

OTHERNone intervation

Observational Study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Abnormal pulmonary function	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
Abnormal cardiovascular function	6 months	LVEF\<50% will be considered an abnormal cardiovascular function test. The dependent variable will be categorized as dichomotoic variables for subsequent analysis.
Abnormal quality of life	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.

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026