Covid19 Clinical Trial
— DISCOVID19Official title:
Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
Verified date | October 2021 |
Source | Hospital Clínico Universitario de Valladolid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínico Universitario de Valladolid | Valladolid |
Lead Sponsor | Collaborator |
---|---|
Hospital Clínico Universitario de Valladolid |
Spain,
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. — View Citation
Aparisi Á, Ybarra-Falcón C, García-Gómez M, Tobar J, Iglesias-Echeverría C, Jaurrieta-Largo S, Ladrón R, Uribarri A, Catalá P, Hinojosa W, Marcos-Mangas M, Fernández-Prieto L, Sedano-Gutiérrez R, Cusacovich I, Andaluz-Ojeda D, de Vega-Sánchez B, Recio-Pla — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aerobic capacity | Measured as peak oxygen uptake | 6 months | |
Primary | Total Lung Capacity (TLC) | Pulmonary function test | 6 months | |
Primary | Force Expiratory Volume in 1 second (FEV1) | Pulmonary function test | 6 months | |
Primary | Difussing Lung Capacity of CO (DLCO) | Pulmonary function test | 6 months | |
Primary | Forced Vital Capacity (FVC) | Pulmonary function test | 6 months | |
Primary | Left Ventricular (LV) Function | Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function) | 6 months | |
Primary | Right Ventricular (RV) Function | Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function) | 6 months | |
Secondary | Short Form 36 Health Survey (SF-36) | Quality of Life test | 6 months | |
Secondary | Kansas City Cardiomyopathy Questionnaire (KCCQ) | Quality of Life test | 6 Months | |
Secondary | 6 Minute Walk Test | Walking capacity | 6 months | |
Secondary | N-terminal pro hormone B-type natriuretic peptide (NT-proBNP) | Inflammatory and Cardiac Marker | 6 months | |
Secondary | Troponin-T | Inflammatory and Cardiac Marker | 6 months | |
Secondary | Ferritin | Inflammatory and Cardiac Marker | 6 months | |
Secondary | D-Dimer | Inflammatory and Cardiac Marker | 6 months | |
Secondary | interleukine-6 | Inflammatory and Cardiac Marker | 6 months | |
Secondary | C reactive protein (CRP) | Inflammatory and Cardiac Marker | 6 months |
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