- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04610554
Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide Early After Mild-to-severe COVID-19
Study Overview
Status
Conditions
Detailed Description
Infection with severe acute respiratory syndrome-CoV-2 (SARS-CoV-2) may be asymptomatic or associated with life-threatening interstitial pneumonia. Clinically, patients affected from severe coronavirus disease-19 (COVID-19) are described as exhibiting rapidly progressing acute respiratory failure with unusually low oxygen levels in arterial blood. On computed tomography scans, diffuse, peripheral "ground glass" opacities of the lung are seen while autopsy lung specimens showed diffuse alveolar damage and capillary endothelialitis.
The objective of the current study, conducted in patients who had recovered from mild-to-severe COVID-19 illness, was to test that simultaneously-determined lung diffusing capacity for nitric oxide (NO) and carbon monoxide (CO) may be of great use to early detect post-infective diffusive gas exchange abnormalities. More specifically, we hypothesized that measurement of membrane diffusive conductance for CO and pulmonary capillary volume may provide accurate information on residual changes of peripheral gas exchanging units of the lung related to previous SARS-CoV-2 infection.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Genoa, Italy, 16132
- IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- subjects were selected after two nasopharyngeal swabs negative for SARS-CoV-2
Exclusion Criteria:
- severe comorbidities potentially affecting pulmonary gas exchange
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung diffusing capacity for nitric oxide (DLNO)
Time Frame: At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2
|
Changes of DLNO after SARS-CoV-2 infection
|
At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lung diffusing capacity for carbon monoxide (DLco)
Time Frame: At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2
|
Changes of DLco after SARS-CoV-2 infection
|
At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2
|
Collaborators and Investigators
Investigators
- Principal Investigator: Giovanni Barisione, MD, Sponsor should be IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Publications and helpful links
General Publications
- Barisione G, Brusasco C, Garlaschi A, Baroffio M, Brusasco V. Lung diffusing capacity for nitric oxide as a marker of fibrotic changes in idiopathic interstitial pneumonias. J Appl Physiol (1985). 2016 May 1;120(9):1029-38. doi: 10.1152/japplphysiol.00964.2015. Epub 2016 Feb 18.
- Barisione G, Bacigalupo A, Brusasco C, Scanarotti C, Penco S, Bassi AM, Lamparelli T, Garlaschi A, Pellegrino R, Brusasco V. Mechanisms for reduced pulmonary diffusing capacity in haematopoietic stem-cell transplantation recipients. Respir Physiol Neurobiol. 2014 Apr 1;194:54-61. doi: 10.1016/j.resp.2014.01.018. Epub 2014 Feb 1.
- Barisione G, Garlaschi A, Occhipinti M, Baroffio M, Pistolesi M, Brusasco V. Value of lung diffusing capacity for nitric oxide in systemic sclerosis. Physiol Rep. 2019 Aug;7(13):e14149. doi: 10.14814/phy2.14149.
- Barisione G, Brusasco V. Lung diffusing capacity for nitric oxide and carbon monoxide following mild-to-severe COVID-19. Physiol Rep. 2021 Feb;9(4):e14748. doi: 10.14814/phy2.14748.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SARS-CoV-2_DLNO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19 Pneumonia
-
ModeX Therapeutics, An OPKO Health CompanyRecruitingCOVID -19 | COVID-19 (Prevention)United States
-
Ministry of Health, KuwaitUnknownPneumonia, Viral | Moderate COVID-19 Pneumonia, Severe COVID-19 PneumoniaKuwait
-
PfizerActive, not recruitingCOVID-19 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | COVID-19 Vaccines | SARS-CoV-2 Infection, COVID19 | COVID-19 Vaccination | SARS-CoV-2 Infection, COVID-19 | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionUnited States
-
PfizerRecruitingRespiratory Tract Diseases | COVID-19 | Pneumonia | Lung Diseases | Coronavirus Disease 2019 | Coronavirus Disease 2019 (COVID-19) | COVID-19 Infection | Upper Respiratory Tract Infections | Respiratory Tract Infection | COVID-19 (Coronavirus Disease 2019) | COVID-19 SARS-CoV-2 InfectionBelgium
-
Institute of Vaccines and Medical Biologicals,...National Institute of Hygiene and Epidemiology, Vietnam; Hanoi Medical UniversityCompletedPneumonia, Viral | COVID-19 Vaccine | COVID-19 Disease | SARS PneumoniaVietnam
-
Patrick RobinsonRecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute BronchitisUnited States
-
Mahidol UniversityThe Government Pharmaceutical OrganizationCompletedPneumonia, Viral | Covid-19 | SARS Pneumonia | Covid-19 VaccineThailand
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
Rigshospitalet, DenmarkCompleted
-
PeptiDream Inc.PeptiAID Inc.Completed