MedDataX Logo

Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

NCT ID: NCT04689490

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Covid19 Dyspnea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Cardiopulmonary exercise test

Intervention Type DIAGNOSTIC_TEST

Only diagnostic tests

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.

Cardiopulmonary exercise test

Intervention Type DIAGNOSTIC_TEST

Only diagnostic tests

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardiopulmonary exercise test

Only diagnostic tests

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

walking test pulmonary lung test echocardiography blood sampling

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ignacio J. Amat Santos

Coordinator of Interventional Cardiology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clínico Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33092736 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32449782 (View on PubMed)

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.

Reference Type RESULT
PMID: 34208271 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CASVE PI-20-1894

Identifier Type: -

Identifier Source: org_study_id