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

Universidad Peruana Cayetano Heredia

Status: Unknown

Conditions: COVID-19

Treatments: Other: None intervation

Study type: Observational

Funder types: Other

Identifiers

NCT05386485

IN-US-983-6130 (Other Grant/Funding Number)

SIDISI 203725

Details and patient eligibility

About

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.

Enrollment: 162 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

162 participants in 5 patient groups

Group A (asymptomatic infection)

Description:

Absence of clinical manifestation during the acute phase of SARS-CoV-2 infection until discharge.

Treatment:

Other: None intervation

Group B1 (mild symptomatic infection)

Description:

Clinical manifestation of the infection without severity signs (respiratory rate \< 30/minute; peripheral oxygen saturation (SpO2) \>94%) and no radiological evidence of pneumonia

Treatment:

Other: None intervation

Group B2 (moderate symptomatic infection)

Description:

Clinical manifestation of the infection without severity signs (respiratory rate \< 30/minute; peripheral oxygen saturation (SpO2) \>94%) and radiological evidence of pneumonia

Treatment:

Other: None intervation

Group B3 (severe symptomatic infection)

Description:

Clinical manifestation of the infection with severity signs (respiratory rate \> 30/minute; peripheral oxygen saturation (SpO2) \<94%) and radiological evidence of pneumonia

Treatment:

Other: None intervation

Group B4 (critical symptomatic infection)

Description:

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

Treatment:

Other: None intervation