Clinical trial NCT04610554: Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide Early After Mild-to-severe COVID-19
Official title: Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide Early After Mild-to-severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pneumonia
Keywords: COVID-19
Lead sponsor: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 74
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: We collected the data of 74 Caucasian consecutive subjects admitted to hospital who had recovered from mild-to-severe COVID-19 and attended our laboratory as outpatients for follow-up purposes

Brief summary: Infection with severe acute respiratory syndrome-CoV-2 (SARS-CoV-2) may be associated with diffuse alveolar damage and pulmonary vasculitis. Thus, it is likely that pulmonary function changes may be seen in COVID-19 survivors. The aim of the present study was to test that simultaneously-determined lung diffusing capacity for nitric oxide and carbon monoxide may be useful to detect post-viral diffusive gas exchange abnormalities early after mild-to-severe COVID-19-related pneumonias.

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.

Eligibility criteria: Inclusion Criteria:

* subjects were selected after two nasopharyngeal swabs negative for SARS-CoV-2

Exclusion Criteria:

* severe comorbidities potentially affecting pulmonary gas exchange

Primary outcomes:
measure: Lung diffusing capacity for nitric oxide (DLNO)
timeFrame: At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2
Secondary outcomes:
measure: Lung diffusing capacity for carbon monoxide (DLco)
timeFrame: At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2
Other outcomes:
Locations:
city: Genoa
country: Italy
facility: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro
Study officials:
affiliation: Sponsor should be IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
name: Giovanni Barisione, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.