Long COVIDLong_COVID_ExNCT05430503
Long COVID and Post-exertional Pulmonary Diffusion
An observational study of Long COVID and Breathlessness, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
Trial summary
Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) in long COVID may have a clinical impact in relation to exercise intolerance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Long COVID, Breathlessness, Exercise Intolerance
- What is being tested?
- Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise
- Type of treatment
- Vaccines
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2022to 15 Jun 2022
- How long will I take part?
- 2 Months
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction. They were referred to our pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.
Who may be able to join
- History of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.
Who cannot join
- History of diseases potentially causing dyspnea or affecting pulmonary gas transport, i.e., bronchial asthma, lung bullous disease, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis or vasculitis, hematological diseases, systemic collagen diseases, congestive heart failure, liver or renal diseases, and morbid obesity.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Ospedale Policlinico San Martino IRCCS - S.S. Fisiopatologia Respiratoria
Genoa, 16132
About this study
Official title: Lung Diffusing Capacities for Nitric Oxide and Carbon Monoxide in Long COVID With Dyspnea at Rest and After Mild Exercise
Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) in long COVID may have a clinical impact in relation to exercise intolerance.
Read the detailed description
Prolonged recovery from acute coronavirus disease 2019 (long COVID) is characterized in about 30% of subjects from breathlessness and fatigue also during daily activities often associated to decreased lung diffusing capacity for carbon monoxide (DLCO) at rest. Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and DLCO in long COVID may have a clinical impact in relation to exercise intolerance. Combined DLNO and DLCO were simultaneously measured at rest and immediately after a short bout of treadmill walking in 32 dyspneic subjects ≥3 months after the COVID-19 acute phase. A group of healthy subjects served as a control group.
- Conditions
- Long COVID, Breathlessness, Exercise Intolerance, Alveolar Lung Disease, Pulmonary Gas Exchange
- Being tested
- Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise
- Medical subject headings
- Post-Acute COVID-19 Syndrome, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exerciseDiagnostic test
DLNO and DLCO were measured at rest and 5-10 s after a bout of treadmill exercise simulating usual walking
| Study group | Role | What they receive |
|---|---|---|
| Long COVID | Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction were included in the study. They were referred to investigators' pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months. Receives: Diagnostic Test: Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise | |
| Healthy controls | Anthropometrically-matched healthy subjects, without history of COVID-19 and vaccinated against SARS-CoV-2 infection. Receives: Diagnostic Test: Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined DLNO and DLCO changes after mild exercise
pulmonary gas exchange abnormalities in dyspneic long COVID subjects
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start24 May 2022
- Primary completion15 Jun 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long COVIDStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Barisione, IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430503
- Sponsor's protocol ID
- Long_COVID_Exer_DLNO_DLCO
- Acronym
- Long_COVID_Ex
- Status last verified
- Jun 2022
- First submitted
- 19 Jun 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Diffusing Capacities for Nitric Oxide and Carbon Monoxide in Long COVID With Dyspnea at Rest and After Mild Exercise
- ClinicalTrials.gov ID
- NCT05430503
- Acronym / sponsor ID
- Long_COVID_Ex / Long_COVID_Exer_DLNO_DLCO
- Conditions
- Long COVID, Breathlessness, Exercise Intolerance, Alveolar Lung Disease, Pulmonary Gas Exchange
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, ItalyUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 15 Jun 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 24 Jun 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.
Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and carbon monoxide (DLCO) in long COVID may have a clinical impact in relation to exercise intolerance.
Detailed description
Prolonged recovery from acute coronavirus disease 2019 (long COVID) is characterized in about 30% of subjects from breathlessness and fatigue also during daily activities often associated to decreased lung diffusing capacity for carbon monoxide (DLCO) at rest. Aim of investigators was to study whether abnormalities of lung diffusing capacity for nitric oxide (DLNO) and DLCO in long COVID may have a clinical impact in relation to exercise intolerance. Combined DLNO and DLCO were simultaneously measured at rest and immediately after a short bout of treadmill walking in 32 dyspneic subjects ≥3 months after the COVID-19 acute phase. A group of healthy subjects served as a control group.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long COVID | – | Diagnostic Test: Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exerciseCaucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction were included in the study. They were referred to investigators' pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months. |
| Healthy controls | – | Diagnostic Test: Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exerciseAnthropometrically-matched healthy subjects, without history of COVID-19 and vaccinated against SARS-CoV-2 infection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction. They were referred to our pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.
Key inclusion criteria (1 listed)
- History of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.
Key exclusion criteria (1 listed)
- History of diseases potentially causing dyspnea or affecting pulmonary gas transport, i.e., bronchial asthma, lung bullous disease, chronic obstructive pulmonary disease, pulmonary interstitial fibrosis or vasculitis, hematological diseases, systemic collagen diseases, congestive heart failure, liver or renal diseases, and morbid obesity.
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 |
|---|---|---|
| Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exerciseDLNO and DLCO were measured at rest and 5-10 s after a bout of treadmill exercise simulating usual walking | Diagnostic test | Healthy controls, Long COVID |
Primary outcome
Combined DLNO and DLCO changes after mild exercise
Time frame: through study completion, an average of 6 months
pulmonary gas exchange abnormalities in dyspneic long COVID subjects
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 24 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Long COVID
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Not yet recruitingPhase 2
Study of VYD2311 for the Treatment of Adults With Long-COVID or Post-Vaccination Syndrome
Long COVID, COVID-19 (SARS-CoV-2 Infection)
Enrolling by invitationPhase 2
Immunotherapy for Neurological Post-Acute Sequelae of SARS-CoV-2
Systemic Inflammation, Neuroinflammation
Active, not recruitingObservational study
Pain in Long COVID-19: The Role of Sleep
Long COVID
RecruitingPhase 2
DAOIB for the Treatment of Brain Fog
Long COVID
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 Long COVID and Breathlessness, run by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy at 1 site in Italy.
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 1 inclusion and 1 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 24 Jun 2022. 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 Italy. 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?
Combined DLNO and DLCO changes after mild exercise (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2022.