Lung Diffusing Capacity for Nitric Oxide and Carbon Monoxide Early After Mild-to-severe COVID-19

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Genoa, Italy, 16132
        • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 14, 2020

Primary Completion (ACTUAL)

October 12, 2020

Study Completion (ACTUAL)

October 12, 2020

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (ACTUAL)

October 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 30, 2020

Last Update Submitted That Met QC Criteria

October 29, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

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