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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Other: None intervation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A (asymptomatic infection)<br>Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge. | Other: None intervation<br>* Observational Study<br>|
| Group B1 (mild symptomatic infection)<br>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<br>* Observational Study<br>|
| Group B2 (moderate symptomatic infection)<br>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<br>* Observational Study<br>|
| Group B3 (severe symptomatic infection)<br>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<br>* Observational Study<br>|
| Group B4 (critical symptomatic infection)<br>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<br>* Observational Study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal pulmonary function | % 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Long COVID, COVID19 Sequelae, Function test, SARS-Cov-2, Cardiovascular function, Respiratory function, Life quality