NCT04610554

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 14, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
Last Updated

October 30, 2020

Status Verified

October 1, 2020

Enrollment Period

5 months

First QC Date

October 29, 2020

Last Update Submit

October 29, 2020

Conditions

Keywords

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Lung diffusing capacity for nitric oxide (DLNO)

    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 Outcomes (1)

  • Lung diffusing capacity for carbon monoxide (DLco)

    At a time interval ranging from 15 to 189 days after two nasopharyngeal swabs negative for SARS-CoV-2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • severe comorbidities potentially affecting pulmonary gas exchange

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Genoa, 16132, Italy

Location

Related Publications (4)

  • 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.

    PMID: 26893034BACKGROUND
  • 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.

    PMID: 24495442BACKGROUND
  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Giovanni Barisione, MD

    Sponsor should be IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD - Chief, Respiratory Pathophysiology Unit

Study Record Dates

First Submitted

October 29, 2020

First Posted

October 30, 2020

Study Start

May 14, 2020

Primary Completion

October 12, 2020

Study Completion

October 12, 2020

Last Updated

October 30, 2020

Record last verified: 2020-10

Locations