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Completed

NCT Number: NCT04689490

Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

We conducted a national, single center (Hospital Clínico Universitario de Valladolid, Spain, Valladolid), prospective study of patients with prior hospitalization because of COVID-19 who were admitted between March 1st, 2020, and May 15th, 2020. All eligible patients underwent at least at first-time follow-up from the index event. Exclusion criteria were age < 18 years old, pregnant women, terminally ill patients, active SARS-CoV-2 infections, inability to exercise and previous known severe pulmonary or heart disease. Patients underwent a clinical assessment for symptom burden, questionnaire for quality of life (Kansas City Cardiomyopathy Questionnaire and SF-36), venous blood sampling, 6-minute walking test (6-MWT), tests of lung function (spirometry and diffusing capacity of the lungs for carbon monoxide) and treadmill cardio-pulmonary exercise testing (CPET). 48-hours before the test of lung function and the CPET, all patients yielded a negative result in the reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2. For definitive analysis patients were assigned to the control group if they did not refer dyspnea at the time of the follow-up, a small asymptomatic out-patient control group without prior hospitalization was also included.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed Informed Consent
  • Previous COVID-19 hospitalization with successful discharged
  • Availability of at least one follow up per clinical protocol

Exclusion criteria

  • pregnant women
  • terminally ill patients
  • active SARS-CoV-2 infections
  • inability to exercise
  • previous known severe pulmonary or heart disease

Treatment and study plan

cardiopulmonary exercise test

Diagnostic Test

Only diagnostic tests

Other names: walking test, pulmonary lung test, echocardiography, blood sampling

Primary outcomes

  1. Aerobic capacity

    Time frame: 6 months

    Measured as peak oxygen uptake

  2. Total Lung Capacity (TLC)

    Time frame: 6 months

    Pulmonary function test

  3. Force Expiratory Volume in 1 second (FEV1)

    Time frame: 6 months

    Pulmonary function test

  4. Difussing Lung Capacity of CO (DLCO)

    Time frame: 6 months

    Pulmonary function test

  5. Forced Vital Capacity (FVC)

    Time frame: 6 months

    Pulmonary function test

  6. Left Ventricular (LV) Function

    Time frame: 6 months

    Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)

  7. Right Ventricular (RV) Function

    Time frame: 6 months

    Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)

Secondary outcomes

  1. Short Form 36 Health Survey (SF-36)

    Time frame: 6 months

    Quality of Life test

  2. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 6 Months

    Quality of Life test

  3. 6 Minute Walk Test

    Time frame: 6 months

    Walking capacity

  4. N-terminal pro hormone B-type natriuretic peptide (NT-proBNP)

    Time frame: 6 months

    Inflammatory and Cardiac Marker

  5. Troponin-T

    Time frame: 6 months

    Inflammatory and Cardiac Marker

  6. Ferritin

    Time frame: 6 months

    Inflammatory and Cardiac Marker

  7. D-Dimer

    Time frame: 6 months

    Inflammatory and Cardiac Marker

  8. interleukine-6

    Time frame: 6 months

    Inflammatory and Cardiac Marker

  9. C reactive protein (CRP)

    Time frame: 6 months

    Inflammatory and Cardiac Marker

Sponsors and collaborators

Lead sponsor

Hospital Clínico Universitario de Valladolid

Other

Registry information

Acronym: DISCOVID19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 30, 2020
Registry last updated
Oct 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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