Dual MRI for Cardiopulmonary COVID-19 Long Haulers

NCT04828135 | Completed Phase 2 Results FDA Drug

• 1 other identifier: Pro00107681
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

The next phase of the COVID-19 pandemic is likely to see a surge in an associated chronic cardiopulmonary disease that will challenge health systems. Recovered patients are presenting with persistent dyspnea at the Duke Pulmonary Post-COVID clinic. Evidence is now mounting that recovered patients have significant residual pulmonary disease, while myocardial injury has also been increasingly reported. To optimally care for these patients, Duke Pulmonary study team must comprehensively assess and monitor the changes in cardiopulmonary function and relate the changes to physiologic and quality of life outcomes. The study team will deploy cutting-edge MRI to fully characterize cardiopulmonary function in enrolled 30 subjects (accrual 23 subjects) at time point 60-120 days post recovery and 6-9 months later. Cardiac MRI will assess the myocardial status and right ventricular function, while hyperpolarized 129Xe MRI will provide a 3D assessment of pulmonary ventilation, interstitial barrier integrity, and pulmonary vascular hemodynamics. The overall objective outlined in this study is to demonstrate the feasibility and value of comprehensive longitudinal imaging characterization of cardiopulmonary structure and function in patients recovered from Covid-19.

Conditions

Covid19

Keywords

MRI; Hyperpolarized 129Xe

Outcome Measures

Primary Outcomes (9)

• Red Blood Cell to Membrane (RBC:M) Ratio

  To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.

  1 year

• Ventilation Defect Percent

  To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.

  1 year

• High Membrane Percent

  To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.

  1 year

• Red Blood Cell (RBC) Defect Percent

  To determine cardiopulmonary structure-function abnormalities that characterize early phase COVID-19 recovery.

  1 year

• Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months

  To characterize the evolution of cardiopulmonary abnormalities over 9 months.

  9 Months

• Ventilation Defect Percent at 9 Months

  To characterize the evolution of cardiopulmonary abnormalities over 9 months.

  9 months

• High Membrane Percent at 9 Months

  To characterize the evolution of cardiopulmonary abnormalities over 9 months.

  9 months

• Red Blood Cell (RBC) Defect Percent at 9 Months

  To characterize the evolution of cardiopulmonary abnormalities over 9 months.

  9 months

• Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)

  DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood.

  Baseline

Study Arms (1)

subjects with diagnosis of COVID-19 (Long-hauler)

EXPERIMENTAL

23 subjects with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer

Drug: Hyperpolarized 129Xenon gas

Interventions

Hyperpolarized 129Xenon gas DRUG

Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),

Also known as: Xe MRI

subjects with diagnosis of COVID-19 (Long-hauler)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18-year-old
• Tested positive for SARS-CoV2
• Willing and able to give informed consent and adhere to visit/protocol scheduled (consent must be given before any study procedures are performed)

You may not qualify if:

• Prisoners
• Pregnant, planning pregnancy, or lactating
• Conditions that prohibit MRI scanning (metal in eye, claustrophobia, inability to lie supine).
• Medical or psychological conditions which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements

Sponsors & Collaborators

• Bastiaan Driehuys: lead

Study Sites (1)

Duke Asthma, Allergy, and Airway Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Loretta Que
• Organization: Duke University

loretta.que@duke.edu

919-681-8551

Study Officials

• Loretta Que, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Radiology

Model Details: This will be a single-blinded open-label study enrolling 30 subjects (accrued 23 subjects (13 subjects who continue to have respiratory symptoms and 10 subjects within competitive sports) with a laboratory-confirmed diagnosis of COIVD-19 infection, and after 60 days or longer

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: April 1, 2021
• Study Start: May 26, 2021
• Primary Completion: April 20, 2023
• Study Completion: April 20, 2023
• Last Updated: May 6, 2024
• Results First Posted: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)