Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

Covid19 Clinical Trial

— DISCOVID19  

Official title:

Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04689490
• Other study ID #: CASVE PI-20-1894
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Hospital Clínico Universitario de Valladolid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• COVID-19
• Covid19
• Dyspnea

Intervention

Diagnostic Test:
• Cardiopulmonary exercise test
Only diagnostic tests

Locations

Country	Name	City	State
Spain	Hospital Clínico Universitario de Valladolid	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clínico Universitario de Valladolid

Country where clinical trial is conducted

Spain, 

References & Publications (3)

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

Outcome

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