Long COVID and Post-exertional Pulmonary Diffusion

Long COVID Clinical Trial

— Long_COVID_Ex  

Official title:

Lung Diffusing Capacities for Nitric Oxide and Carbon Monoxide in Long COVID With Dyspnea at Rest and After Mild Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05430503
• Other study ID #: Long_COVID_Exer_DLNO_DLCO
• Status: Completed
• Start date: May 24, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: June 2022
• Source: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• History of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting =2 months.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Alveolar Lung Disease
• Breathlessness
• Dyspnea
• Exercise Intolerance
• Long COVID
• Lung Diseases
• Pulmonary Gas Exchange

Intervention

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
DLNO and DLCO were measured at rest and 5-10 s after a bout of treadmill exercise simulating usual walking

Locations

Country	Name	City	State
Italy	Ospedale Policlinico San Martino IRCCS - S.S. Fisiopatologia Respiratoria	Genoa

Sponsors (1)

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

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined DLNO and DLCO changes after mild exercise	pulmonary gas exchange abnormalities in dyspneic long COVID subjects	through study completion, an average of 6 months