Long COVID and Post-exertional Pulmonary Diffusion

NCT05430503 | Completed

• 1 other identifier: Long_COVID_Exer_DLNO_DLCO
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Long COVID; Breathlessness; Exercise Intolerance; Alveolar Lung Disease; Pulmonary Gas Exchange

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Long COVID

Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction were included in the study. They were referred to investigators' pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.

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

Healthy controls

Anthropometrically-matched healthy subjects, without history of COVID-19 and vaccinated against SARS-CoV-2 infection.

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

Interventions

Lung volumes, spirometry and standard single-breath DLCO were measured at rest while combined DLNO and DLCO were measured at rest and post-exercise DIAGNOSTIC_TEST

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

Healthy controls; Long COVID

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Caucasian subjects with a history of SARS CoV-2 infection confirmed by nasopharyngeal swab with real-time polymerase-chain reaction. They were referred to our pulmonary function laboratory after being tested negative for SARS-CoV-2, because of dyspnea, fatigue, and exercise intolerance persisting or occurring at least 3 months after the COVID-19 acute phase and lasting ≥2 months.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Ospedale Policlinico San Martino IRCCS - S.S. Fisiopatologia Respiratoria

Genoa, 16132, Italy

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Dyspnea

Interventions

Lung Volume Measurements; Spirometry

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Respiratory Pathophysiology

Study Record Dates

• First Submitted: June 19, 2022
• First Posted: June 24, 2022
• Study Start: May 24, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: June 24, 2022

Record last verified: 2022-06

Locations

IT (1)