Clinical trial NCT04689490: Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
Official title: Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Dyspnea
Keywords: Dyspnea
Covid19
Cardiopulmonary exercise test
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with prior hospitalization because of COVID-19 who were admitted between March and May. All eligible patient 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.

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.


Eligibility 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

Primary outcomes:
measure: Aerobic capacity
timeFrame: 6 months
measure: Total Lung Capacity (TLC)
timeFrame: 6 months
measure: Force Expiratory Volume in 1 second (FEV1)
timeFrame: 6 months
measure: Difussing Lung Capacity of CO (DLCO)
timeFrame: 6 months
measure: Forced Vital Capacity (FVC)
timeFrame: 6 months
measure: Left Ventricular (LV) Function
timeFrame: 6 months
measure: Right Ventricular (RV) Function
timeFrame: 6 months
Secondary outcomes:
measure: Short Form 36 Health Survey (SF-36)
timeFrame: 6 months
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 6 Months
measure: 6 Minute Walk Test
timeFrame: 6 months
measure: N-terminal pro hormone B-type natriuretic peptide (NT-proBNP)
timeFrame: 6 months
measure: Troponin-T
timeFrame: 6 months
measure: Ferritin
timeFrame: 6 months
measure: D-Dimer
timeFrame: 6 months
measure: interleukine-6
timeFrame: 6 months
measure: C reactive protein (CRP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
Study officials:
References:
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.
citation: 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.
citation: Aparisi A, Ybarra-Falcon C, Garcia-Gomez M, Tobar J, Iglesias-Echeverria C, Jaurrieta-Largo S, Ladron R, Uribarri A, Catala P, Hinojosa W, Marcos-Mangas M, Fernandez-Prieto L, Sedano-Gutierrez R, Cusacovich I, Andaluz-Ojeda D, de Vega-Sanchez B, Recio-Platero A, Sanz-Patino E, Calvo D, Baladron C, Carrasco-Moraleja M, Disdier-Vicente C, Amat-Santos IJ, San Roman JA. Exercise Ventilatory Inefficiency in Post-COVID-19 Syndrome: Insights from a Prospective Evaluation. J Clin Med. 2021 Jun 11;10(12):2591. doi: 10.3390/jcm10122591.