DISCOVID19: Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
Study Details
Study Description
Brief Summary
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Dyspnea Patients with prior hospitalization because of COVID-19, with succesful hospital discharge, who underwent at least a first-time follow-up from the index event, and present persistent dyspnea. |
Diagnostic Test: Cardiopulmonary exercise test
Only diagnostic tests
Other Names:
|
| Control Patients with prior hospitalization because of COVID-19, with succesful hospital discharge, who underwent at least a first-time follow-up from the index event, fully recovered, without persistent dyspnea. |
Diagnostic Test: Cardiopulmonary exercise test
Only diagnostic tests
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Aerobic capacity [6 months]
Measured as peak oxygen uptake
- Total Lung Capacity (TLC) [6 months]
Pulmonary function test
- Force Expiratory Volume in 1 second (FEV1) [6 months]
Pulmonary function test
- Difussing Lung Capacity of CO (DLCO) [6 months]
Pulmonary function test
- Forced Vital Capacity (FVC) [6 months]
Pulmonary function test
- Left Ventricular (LV) Function [6 months]
Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)
- Right Ventricular (RV) Function [6 months]
Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)
Secondary Outcome Measures
- Short Form 36 Health Survey (SF-36) [6 months]
Quality of Life test
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [6 Months]
Quality of Life test
- 6 Minute Walk Test [6 months]
Walking capacity
- N-terminal pro hormone B-type natriuretic peptide (NT-proBNP) [6 months]
Inflammatory and Cardiac Marker
- Troponin-T [6 months]
Inflammatory and Cardiac Marker
- Ferritin [6 months]
Inflammatory and Cardiac Marker
- D-Dimer [6 months]
Inflammatory and Cardiac Marker
- interleukine-6 [6 months]
Inflammatory and Cardiac Marker
- C reactive protein (CRP) [6 months]
Inflammatory and Cardiac Marker
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clínico Universitario de Valladolid | Valladolid | Spain | 47003 |
Sponsors and Collaborators
- Hospital Clínico Universitario de Valladolid
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Ahmed H, Patel K, Greenwood DC, Halpin S, Lewthwaite P, Salawu A, Eyre L, Breen A, O'Connor R, Jones A, Sivan M. Long-term clinical outcomes in survivors of severe acute respiratory syndrome and Middle East respiratory syndrome coronavirus outbreaks after hospitalisation or ICU admission: A systematic review and meta-analysis. J Rehabil Med. 2020 May 31;52(5):jrm00063. doi: 10.2340/16501977-2694.
- Pinney SP, Giustino G, Halperin JL, Mechanick JI, Neibart E, Olin JW, Rosenson RS, Fuster V. Coronavirus Historical Perspective, Disease Mechanisms, and Clinical Outcomes: JACC Focus Seminar. J Am Coll Cardiol. 2020 Oct 27;76(17):1999-2010. doi: 10.1016/j.jacc.2020.08.058. Review.
- CASVE PI-20-1894