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

• Conditions: COVID-19
• Interventions: Other: None intervation

• Registration Number: NCT05386485
• Lead Sponsor: Universidad Peruana Cayetano Heredia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-07
• Status Verified: 2022-05
• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-23
• Last Update Submitted: 2022-08-28
• Last Update Posted: 2022-08-30
• Primary Completion: 2022-10
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 162

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Instituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia; 🇵🇪 Lima Lima, Lima, Peru