covid_19 PatientsNCT05228678
Persistent Dyspnea in Post COVID_19 and Pulmonary Function
An observational study of covid_19 Patients, run by Assiut University.
Trial summary
COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- covid_19 Patients
- What is being tested?
- cardiopulmonary exercise tests
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Apr 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: patients who are diagnosed as post covid_19 who were admittted to isolation unit of Assiut University Hospitals or visit the post covid_19 outpatient clinic
Who may be able to join
- Confirmed or clinically and radiologically highly suspected Covid19-infection
- Symptom duration at least 12 weeks following first occurrence of symptoms
- Patients with dyspnea score 2, 3 and 4 on mMRC
- No other disease that better could explain the symptoms (dyspnea) than Covid-19
Who cannot join
- Age <18
- pregnant women
- terminally ill patients
- active covid-19 infection
- previous known severe pulmonary or heart disease
- inability to perform pulmonary function or cardiopulmonary exercise tests.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Persistent Dyspnea in Post-COVID-19 Patients: Value of Cardiopulmonary Exercise Tests
COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU)
Read the detailed description
COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU) Many patients with mild or severe COVID-19 do not make a full recovery and have a wide range of chronic symptoms for weeks or months after infection.
Post-COVID-19 syndrome is defined by persistent clinical signs and symptoms that appear while or after suffering COVID-19, persist for more than 12 weeks and cannot be explained by an alternative diagnosis.
Dyspnea is one of the most prevalent symptoms in post-covid-19 patients in up to 29% of patients with post COVID-19 syndrome.
Also, persistent dyspnea in post COVID-19 infection is frequent, it is so far, of unknown mechanism. Cardiopulmonary Exercise Test (CPET) is currently the gold standard technique in the differential diagnosis of dyspnea.
Cardiopulmonary exercise testing (CPET) is useful in the assessment of subjects with chronic lung conditions as it may help to: 1) recognize physiological factors limiting exercise (with or without the presence of psychogenic limiting factors); 2) identify these factors as potential therapeutic targets; 3) allow quantification of the level of impairment; 4) assess the effects of an intervention; and 5) provide prognostic information.
- Conditions
- covid_19 Patients
- Being tested
- cardiopulmonary exercise tests
- Keywords
- post covid_19,dyspnea, cardiopulmonary exercise
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiopulmonary exercise testsDiagnostic test
Also called spirometry
Spirometry
- forced expiratory volume in 1 second (FEV1) % predicted,
- forced vital capacity (FVC)% predicted,
- forced expiratory volume in 1 second /forced vital capacity FEV1 /FVC
| Study group | Role | What they receive |
|---|---|---|
| Dyspnea group | Patients with prior diagnosis of COVID-19 and present with persistent dyspnea after 12 weeks of occurrence of symptoms every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: -
1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.
2. The following parameters observed:
1. Metabolic response
* Oxygen consumption VO2 (ml/ min):
* P ETO2: Is the end-tidal O2 tension as measured from the exhaled air.
* P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise.
* Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy
2. Ventilatory response
* Minute ventilation :
* Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum
* Tidal volume (VT):
* Respiratory frequency (RF) Receives: Diagnostic Test: cardiopulmonary exercise tests | |
| Control group | Patients with prior diagnosis of COVID-19, fully recovered, without persistent dyspnea every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: -
1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.
2. The following parameters observed:
1. Metabolic response
* Oxygen consumption VO2 (ml/ min):
* P ETO2: Is the end-tidal O2 tension as measured from the exhaled air.
* P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise.
* Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy
2. Ventilatory response
* Minute ventilation :
* Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum
* Tidal volume (VT):
* Respiratory frequency (RF) Receives: Diagnostic Test: cardiopulmonary exercise tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC)
Aerobic capacity measured as peak oxygen uptake Total lung capacity measured by spirometry
Measured: two years
Secondary outcomes (1)
Assessment of Walking capacity
measured by 6 Minute Walk Test
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for covid_19 PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Sayed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228678
- Sponsor's protocol ID
- post COVID_19 and dyspnea
- Status last verified
- Feb 2022
- First submitted
- 6 Feb 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
PubMed 32091533Carod-Artal FJ. Post-COVID-19 syndrome: epidemiology, diagnostic criteria and pathogenic mechanisms involved. Rev Neurol. 2021 Jun 1;72(11):384-396. doi: 10.33588/rn.7211.2021230. English, Spanish.
PubMed 34042167Fernandez-de-Las-Penas C, Palacios-Cena D, Gomez-Mayordomo V, Florencio LL, Cuadrado ML, Plaza-Manzano G, Navarro-Santana M. Prevalence of post-COVID-19 symptoms in hospitalized and non-hospitalized COVID-19 survivors: A systematic review and meta-analysis. Eur J Intern Med. 2021 Oct;92:55-70. doi: 10.1016/j.ejim.2021.06.009. Epub 2021 Jun 16.
PubMed 34167876Radtke T, Crook S, Kaltsakas G, Louvaris Z, Berton D, Urquhart DS, Kampouras A, Rabinovich RA, Verges S, Kontopidis D, Boyd J, Tonia T, Langer D, De Brandt J, Goertz YMJ, Burtin C, Spruit MA, Braeken DCW, Dacha S, Franssen FME, Laveneziana P, Eber E, Troosters T, Neder JA, Puhan MA, Casaburi R, Vogiatzis I, Hebestreit H. ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev. 2019 Dec 18;28(154):180101. doi: 10.1183/16000617.0101-2018. Print 2019 Dec 31.
PubMed 31852745Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.
PubMed 33735374
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Dyspnea in Post-COVID-19 Patients: Value of Cardiopulmonary Exercise Tests
- ClinicalTrials.gov ID
- NCT05228678
- Acronym / sponsor ID
- post COVID_19 and dyspnea
- Conditions
- covid_19 Patients
- Keywords
- post covid_19,dyspnea, cardiopulmonary exercise
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 8 Feb 2022 (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.
COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU)
Detailed description
COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU) Many patients with mild or severe COVID-19 do not make a full recovery and have a wide range of chronic symptoms for weeks or months after infection.
Post-COVID-19 syndrome is defined by persistent clinical signs and symptoms that appear while or after suffering COVID-19, persist for more than 12 weeks and cannot be explained by an alternative diagnosis.
Dyspnea is one of the most prevalent symptoms in post-covid-19 patients in up to 29% of patients with post COVID-19 syndrome.
Also, persistent dyspnea in post COVID-19 infection is frequent, it is so far, of unknown mechanism. Cardiopulmonary Exercise Test (CPET) is currently the gold standard technique in the differential diagnosis of dyspnea.
Cardiopulmonary exercise testing (CPET) is useful in the assessment of subjects with chronic lung conditions as it may help to: 1) recognize physiological factors limiting exercise (with or without the presence of psychogenic limiting factors); 2) identify these factors as potential therapeutic targets; 3) allow quantification of the level of impairment; 4) assess the effects of an intervention; and 5) provide prognostic information.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyspnea group | – | Diagnostic Test: cardiopulmonary exercise testsPatients with prior diagnosis of COVID-19 and present with persistent dyspnea after 12 weeks of occurrence of symptoms every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: - 1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals. 2. The following parameters observed: 1. Metabolic response * Oxygen consumption VO2 (ml/ min): * P ETO2: Is the end-tidal O2 tension as measured from the exhaled air. * P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise. * Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy 2. Ventilatory response * Minute ventilation : * Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum * Tidal volume (VT): * Respiratory frequency (RF) |
| Control group | – | Diagnostic Test: cardiopulmonary exercise testsPatients with prior diagnosis of COVID-19, fully recovered, without persistent dyspnea every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: - 1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals. 2. The following parameters observed: 1. Metabolic response * Oxygen consumption VO2 (ml/ min): * P ETO2: Is the end-tidal O2 tension as measured from the exhaled air. * P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise. * Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy 2. Ventilatory response * Minute ventilation : * Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum * Tidal volume (VT): * Respiratory frequency (RF) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who are diagnosed as post covid_19 who were admittted to isolation unit of Assiut University Hospitals or visit the post covid_19 outpatient clinic
Key inclusion criteria (4 listed)
- Confirmed or clinically and radiologically highly suspected Covid19-infection
- Symptom duration at least 12 weeks following first occurrence of symptoms
- Patients with dyspnea score 2, 3 and 4 on mMRC
- No other disease that better could explain the symptoms (dyspnea) than Covid-19
Key exclusion criteria (6 listed)
- Age <18
- pregnant women
- terminally ill patients
- active covid-19 infection
- 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 testsAlso: spirometrySpirometry * forced expiratory volume in 1 second (FEV1) % predicted, * forced vital capacity (FVC)% predicted, * forced expiratory volume in 1 second /forced vital capacity FEV1 /FVC | Diagnostic test | Control group, Dyspnea group |
Primary outcome
Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC)
Time frame: two years
Aerobic capacity measured as peak oxygen uptake Total lung capacity measured by spirometry
1 secondary outcome
Assessment of Walking capacity
Time frame: two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Results publication: PubMed 32091533Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Results publication: PubMed 34042167Carod-Artal FJ. Post-COVID-19 syndrome: epidemiology, diagnostic criteria and pathogenic mechanisms involved. Rev Neurol. 2021 Jun 1;72(11):384-396. doi: 10.33588/rn.7211.2021230. English, Spanish.
- Results publication: PubMed 34167876Fernandez-de-Las-Penas C, Palacios-Cena D, Gomez-Mayordomo V, Florencio LL, Cuadrado ML, Plaza-Manzano G, Navarro-Santana M. Prevalence of post-COVID-19 symptoms in hospitalized and non-hospitalized COVID-19 survivors: A systematic review and meta-analysis. Eur J Intern Med. 2021 Oct;92:55-70. doi: 10.1016/j.ejim.2021.06.009. Epub 2021 Jun 16.
- Results publication: PubMed 31852745Radtke T, Crook S, Kaltsakas G, Louvaris Z, Berton D, Urquhart DS, Kampouras A, Rabinovich RA, Verges S, Kontopidis D, Boyd J, Tonia T, Langer D, De Brandt J, Goertz YMJ, Burtin C, Spruit MA, Braeken DCW, Dacha S, Franssen FME, Laveneziana P, Eber E, Troosters T, Neder JA, Puhan MA, Casaburi R, Vogiatzis I, Hebestreit H. ERS statement on standardisation of cardiopulmonary exercise testing in chronic lung diseases. Eur Respir Rev. 2019 Dec 18;28(154):180101. doi: 10.1183/16000617.0101-2018. Print 2019 Dec 31.
- Results publication: PubMed 33735374Debeaumont D, Boujibar F, Ferrand-Devouge E, Artaud-Macari E, Tamion F, Gravier FE, Smondack P, Cuvelier A, Muir JF, Alexandre K, Bonnevie T. Cardiopulmonary Exercise Testing to Assess Persistent Symptoms at 6 Months in People With COVID-19 Who Survived Hospitalization: A Pilot Study. Phys Ther. 2021 Jun 1;101(6):pzab099. doi: 10.1093/ptj/pzab099.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
An observational study of covid_19 Patients, run by Assiut University.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa S Ali, assistant lecturer (01064336300 ext. +2, a_s_a.1990@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC) (time frame: two years). 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 NCT05228678, which also lists 5 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 23 Feb 2022.