Covid19DISCOVID19NCT04689490
Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
An observational study of Covid19 and Dyspnea, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Cardiopulmonary exercise test
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2020to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Signed Informed Consent
- Previous COVID-19 hospitalization with successful discharged
- Availability of at least one follow up per clinical protocol
Who cannot join
- pregnant women
- terminally ill patients
- active SARS-CoV-2 infections
- inability to exercise
- previous known severe pulmonary or heart disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Cardiopulmonary exercise test
- Keywords
- Dyspnea, Covid19, Cardiopulmonary exercise test
- Medical subject headings
- COVID-19, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary exercise testDiagnostic test
Also called walking test, pulmonary lung test, echocardiography, blood sampling
Only diagnostic tests
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Cardiopulmonary exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic capacity
Measured as peak oxygen uptake
Measured: 6 months
Total Lung Capacity (TLC)
Pulmonary function test
Measured: 6 months
Force Expiratory Volume in 1 second (FEV1)
Pulmonary function test
Measured: 6 months
Difussing Lung Capacity of CO (DLCO)
Pulmonary function test
Measured: 6 months
Forced Vital Capacity (FVC)
Pulmonary function test
Measured: 6 months
Left Ventricular (LV) Function
Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)
Measured: 6 months
Right Ventricular (RV) Function
Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)
Measured: 6 months
Secondary outcomes (9)
Short Form 36 Health Survey (SF-36)
Quality of Life test
Measured: 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Quality of Life test
Measured: 6 Months
6 Minute Walk Test
Walking capacity
Measured: 6 months
N-terminal pro hormone B-type natriuretic peptide (NT-proBNP)
Inflammatory and Cardiac Marker
Measured: 6 months
Troponin-T
Inflammatory and Cardiac Marker
Measured: 6 months
Ferritin
Inflammatory and Cardiac Marker
Measured: 6 months
D-Dimer
Inflammatory and Cardiac Marker
Measured: 6 months
interleukine-6
Inflammatory and Cardiac Marker
Measured: 6 months
C reactive protein (CRP)
Inflammatory and Cardiac Marker
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio J. Amat Santos, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04689490
- Sponsor's protocol ID
- CASVE PI-20-1894
- Acronym
- DISCOVID19
- Status last verified
- Oct 2021
- First submitted
- 17 Dec 2020
- Last updated
- 25 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33092736Ahmed 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.
PubMed 32449782Aparisi 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.
PubMed 34208271
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04689490
- Acronym / sponsor ID
- DISCOVID19 / CASVE PI-20-1894
- Keywords
- Dyspnea, Covid19, Cardiopulmonary exercise test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyspnea | – | Diagnostic Test: Cardiopulmonary exercise testPatients 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. |
| Control | – | Diagnostic Test: Cardiopulmonary exercise testPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Signed Informed Consent
- Previous COVID-19 hospitalization with successful discharged
- Availability of at least one follow up per clinical protocol
Key exclusion criteria (5 listed)
- pregnant women
- terminally ill patients
- active SARS-CoV-2 infections
- inability to exercise
- previous known severe pulmonary or heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary exercise testAlso: walking test, pulmonary lung test, echocardiography, blood samplingOnly diagnostic tests | Diagnostic test | Control, Dyspnea |
Primary outcome
Aerobic capacity
Time frame: 6 months
Measured as peak oxygen uptake
Total Lung Capacity (TLC)
Time frame: 6 months
Pulmonary function test
Force Expiratory Volume in 1 second (FEV1)
Time frame: 6 months
Pulmonary function test
Difussing Lung Capacity of CO (DLCO)
Time frame: 6 months
Pulmonary function test
Forced Vital Capacity (FVC)
Time frame: 6 months
Pulmonary function test
Left Ventricular (LV) Function
Time frame: 6 months
Left Ventricular (LV) Function (Ecocardiagraphy-measured Cardiac Function)
Right Ventricular (RV) Function
Time frame: 6 months
Right Ventricular (RV) Function (Ecocardiagraphy-measured Cardiac Function)
9 secondary outcomes
Short Form 36 Health Survey (SF-36)
Time frame: 6 months
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 6 Months
6 Minute Walk Test
Time frame: 6 months
N-terminal pro hormone B-type natriuretic peptide (NT-proBNP)
Time frame: 6 months
Troponin-T
Time frame: 6 months
Ferritin
Time frame: 6 months
D-Dimer
Time frame: 6 months
interleukine-6
Time frame: 6 months
C reactive protein (CRP)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Background: PubMed 33092736Pinney 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.
- Background: PubMed 32449782Ahmed 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.
- Results publication: PubMed 34208271Aparisi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Dyspnea, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic capacity (time frame: 6 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04689490, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.