Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

NCT04689490 | Completed

• 1 other identifier: CASVE PI-20-1894
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Dyspnea

Keywords

Dyspnea; Covid19; Cardiopulmonary exercise test

Outcome Measures

Primary Outcomes (7)

• Aerobic capacity

  Measured as peak oxygen uptake

  6 months

• Total Lung Capacity (TLC)

  Pulmonary function test

  6 months

• Force Expiratory Volume in 1 second (FEV1)

  Pulmonary function test

  6 months

• Difussing Lung Capacity of CO (DLCO)

  Pulmonary function test

  6 months

• Forced Vital Capacity (FVC)

  Pulmonary function test

  6 months

• Left Ventricular (LV) Function

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

  6 months

• Right Ventricular (RV) Function

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

  6 months

Secondary Outcomes (9)

• Short Form 36 Health Survey (SF-36)

  6 months

• Kansas City Cardiomyopathy Questionnaire (KCCQ)

  6 Months

• 6 Minute Walk Test

  6 months

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

  6 months

• Troponin-T

  6 months

Study Arms (2)

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

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

Interventions

Cardiopulmonary exercise test DIAGNOSTIC_TEST

Only diagnostic tests

Also known as: walking test, pulmonary lung test, echocardiography, blood sampling

Control; Dyspnea

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clínico Universitario de Valladolid: lead

Study Sites (1)

Hospital Clínico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Related Publications (3)

• 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.

  PMID: 33092736 BACKGROUND

• 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.

  PMID: 32449782 BACKGROUND

• 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.

  PMID: 34208271 RESULT

MeSH Terms

Conditions

COVID-19; Dyspnea

Interventions

Exercise Test; Respiratory Function Tests; Echocardiography; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques; Cardiac Imaging Techniques; Diagnostic Imaging; Ultrasonography; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Interventional Cardiology Unit

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 30, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)