Trial Outcomes & Findings for Dual MRI for Cardiopulmonary COVID-19 Long Haulers (NCT NCT04828135)

NCT ID: NCT04828135

Last Updated: 2024-05-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: 1 year
• Results posted on: 2024-05-06

Participant Flow

Historical Controls were not considered enrolled.

Participant milestones

Measure	Participants With Diagnosis of COVID-19 (Long-hauler) Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
Overall Study STARTED	18
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Dual MRI for Cardiopulmonary COVID-19 Long Haulers

Baseline characteristics by cohort

Measure	Participants With Diagnosis of COVID-19 (Long-hauler) n=18 Participants 23 participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls n=10 Participants 10 participants with historical Hyperpolarized 129Xenon imaging	Total n=28 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants	10 Participants n=7 Participants	25 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	14 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants	10 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls n=10 Participants Participants with no diagnosis of COVID-19 infection
Red Blood Cell to Membrane (RBC:M) Ratio	0.39 ratio (RBC:M) Standard Deviation 0.14	0.51 ratio (RBC:M) Standard Deviation 0.13

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls n=10 Participants Participants with no diagnosis of COVID-19 infection
Ventilation Defect Percent	2.4 percentage of ventilation defect Standard Deviation 3.5	0.6 percentage of ventilation defect Standard Deviation 0.7

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls n=10 Participants Participants with no diagnosis of COVID-19 infection
High Membrane Percent	18.23 percentage of high membrane Standard Deviation 29.4	0.5 percentage of high membrane Standard Deviation 1.3

PRIMARY outcome

Timeframe: 1 year

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

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls n=10 Participants Participants with no diagnosis of COVID-19 infection
Red Blood Cell (RBC) Defect Percent	10.6 percentage of RBC defect Standard Deviation 5.6	4.2 percentage of RBC defect Standard Deviation 4.8

PRIMARY outcome

Timeframe: 9 Months

To characterize the evolution of cardiopulmonary abnormalities over 9 months.

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls Participants with no diagnosis of COVID-19 infection
Red Blood Cell to Membrane (RBC:M) Ratio at 9 Months	0.44 ratio (RBC:M) Standard Deviation 0.14	—

PRIMARY outcome

Timeframe: 9 months

To characterize the evolution of cardiopulmonary abnormalities over 9 months.

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls Participants with no diagnosis of COVID-19 infection
Ventilation Defect Percent at 9 Months	0.5 percentage of ventilation defect Standard Deviation 0.5	—

PRIMARY outcome

Timeframe: 9 months

To characterize the evolution of cardiopulmonary abnormalities over 9 months.

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls Participants with no diagnosis of COVID-19 infection
High Membrane Percent at 9 Months	15 percentage of high membrane Standard Deviation 30.6	—

PRIMARY outcome

Timeframe: 9 months

To characterize the evolution of cardiopulmonary abnormalities over 9 months.

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls Participants with no diagnosis of COVID-19 infection
Red Blood Cell (RBC) Defect Percent at 9 Months	6.2 percentage of RBC defect Standard Deviation 1.8	—

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Subjects With Diagnosis of COVID-19 (Long-hauler) n=13 Participants Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),	Historical Controls Participants with no diagnosis of COVID-19 infection
Identify MRI Features That Predict Physiological Outcomes With DLCO (Diffusing Capacity of the Lungs for Carbon Monoxide)	20 percentage of predicted value Standard Deviation 8	—

Adverse Events

Participants With Diagnosis of COVID-19 (Long-hauler)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Participants With Diagnosis of COVID-19 (Long-hauler) n=18 participants at risk Participants with a confirmed diagnosis of COVID-19 infection, and after 60 days or longer Hyperpolarized 129Xenon gas: Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC)
Respiratory, thoracic and mediastinal disorders Shortness of breath	5.6% 1/18 • Number of events 1 • 9 Months Historical Controls were not monitored/assessed for deaths and/or adverse events.
Respiratory, thoracic and mediastinal disorders Infection	5.6% 1/18 • Number of events 1 • 9 Months Historical Controls were not monitored/assessed for deaths and/or adverse events.
Respiratory, thoracic and mediastinal disorders	5.6% 1/18 • Number of events 1 • 9 Months Historical Controls were not monitored/assessed for deaths and/or adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Loretta Que

Duke University

Phone: 919-681-8551

Email: loretta.que@duke.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place