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Comprehensive Imaging Exam of Convalesced COVID-19 Patients

Primary Purpose

COVID-19, COVID Long-Haul

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging
Ultra-High Resolution Computed Tomography (CT) Scan
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age: 18+ Diagnosed with COVID-19 at any point starting March 2020. Subgroup A: hospitalized due to COVID-19 infection Subgroup B: non-hospitalized Exclusion Criteria: Known allergy to either gadolinium or iodine based contrast agents Glomerular Filtration Rate (GFR) <45 mL/min (using the Cockcroft-Gault formula) Pregnancy Internal electrical devices, such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator Atrial fibrillation, uncontrolled tachyarrhythmia or advanced atrioventricular block (2nd or 3rd degree) at time of imaging Evidence of severe symptomatic heart failure (NYHA Class III or IV) at the time of imaging Other acute illness Ongoing mechanical ventilation related to hospitalization for COVID-19 related illness Presence of any other history or condition that the investigator feels would be problematic Weight exceeding 300 lbs (MRI table weight restrictions) Severe claustrophobia

Sites / Locations

  • Johns Hopkins School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Hospitalized

Non-Hospitalized

Arm Description

Participants who were hospitalized due to their COVID-19 illness.

Participants who had COVID-19 but did not require hospitalization secondary to their illness.

Outcomes

Primary Outcome Measures

Degree and extent of fibrosis
- MRI to assess degree and extent of fibrosis in the liver, lungs, brain, myocardium, and vascular systems

Secondary Outcome Measures

Assessment of Perfusion
Ultra-High Resolution CT to assess the amount of perfusion to the lungs and heart.

Full Information

First Posted
June 23, 2023
Last Updated
June 23, 2023
Sponsor
Johns Hopkins University
Collaborators
Canon Medical Systems, USA
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1. Study Identification

Unique Protocol Identification Number
NCT05920616
Brief Title
Comprehensive Imaging Exam of Convalesced COVID-19 Patients
Official Title
Comprehensive Imaging Exam of Convalesced COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
October 31, 2025 (Anticipated)
Study Completion Date
October 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Canon Medical Systems, USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
COVID-19 is a systemic inflammatory disease involving many organs including the lungs, vascular system liver and myocardium that lead to severe pathologies. Patients with severe cardiopulmonary symptoms usually require weeks to months to fully recover. Studies of clinical and subclinical impairments of COVID-19 patients are important for medical practice and public health as well as providing pathogenic insight to the viral infection and secondary immune response. Chronic damage of vital organs and systems, and the potential long-term effects is of serious concern. In this study the investigators plan to quantify and characterize chronic consequences of COVID-19 in individuals who receive similar medical care related to disease severity and duration in a single health care system. Using state-of-the-art Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) technology, we will study the pathology in major organ systems in comparison to matched controls. The results of this study may facilitate measures to prevent, detect, and manage complications from COVID-19 infections.
Detailed Description
As the number of recovered COVID-19 patients increase around the globe, it is important to understand the longterm impact of the disease so that healthcare systems and providers can optimize follow-up care of these patients. Identifying long term effects may also help identify patients with an increased risk of major adverse events following discharge from the hospital. Currently, the long term effects of COVID-19 in discharged hospitalized patients remain unknown. Infection with COVID-19 may result in involvement of many organ systems, including the lung, heart, brain, liver, and kidneys. Patients with a previous history of cardiovascular disease have been found to be at higher risk for incident cardiovascular complications. Direct or indirect effects of COVID-19 infection may predispose patients to thrombotic events including acute myocardial injury or pulmonary defects. Cardio-pulmonary features of COVID-19 include: bilateral multilobar ground-glass opacifications, septal thickening, bronchiectasis, pleural thickening, and subpleural involvement. Gradual resolution of consolidative opacities and other imaging patterns associated with clinical improvement usually occur after the second week of the disease. Characterization and quantification of organ injury as well associated organ dysfunction may help facilitating appropriate prevention and management.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, COVID Long-Haul

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
210 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hospitalized
Arm Type
Other
Arm Description
Participants who were hospitalized due to their COVID-19 illness.
Arm Title
Non-Hospitalized
Arm Type
Other
Arm Description
Participants who had COVID-19 but did not require hospitalization secondary to their illness.
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.
Intervention Type
Other
Intervention Name(s)
Ultra-High Resolution Computed Tomography (CT) Scan
Intervention Description
Completion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries.
Primary Outcome Measure Information:
Title
Degree and extent of fibrosis
Description
- MRI to assess degree and extent of fibrosis in the liver, lungs, brain, myocardium, and vascular systems
Time Frame
Analyzed within 6 months of study completion
Secondary Outcome Measure Information:
Title
Assessment of Perfusion
Description
Ultra-High Resolution CT to assess the amount of perfusion to the lungs and heart.
Time Frame
Analyzed within 6 months of study completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age: 18+ Diagnosed with COVID-19 at any point starting March 2020. Subgroup A: hospitalized due to COVID-19 infection Subgroup B: non-hospitalized Exclusion Criteria: Known allergy to either gadolinium or iodine based contrast agents Glomerular Filtration Rate (GFR) <45 mL/min (using the Cockcroft-Gault formula) Pregnancy Internal electrical devices, such as cochlear implant, spinal cord stimulator, pacemaker, or defibrillator Atrial fibrillation, uncontrolled tachyarrhythmia or advanced atrioventricular block (2nd or 3rd degree) at time of imaging Evidence of severe symptomatic heart failure (NYHA Class III or IV) at the time of imaging Other acute illness Ongoing mechanical ventilation related to hospitalization for COVID-19 related illness Presence of any other history or condition that the investigator feels would be problematic Weight exceeding 300 lbs (MRI table weight restrictions) Severe claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joao Lima, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data obtained through this study may provided to qualified researchers with academic interest in COVID-19. Data shared will not contain any personal health information (PHI). A statement of work and data use agreement are pre-requisites for data sharing.
IPD Sharing Time Frame
Data requests can be submitted starting 12 months after article publication. Data will be made accessible up to 24 months with extensions considered as needed.
IPD Sharing Access Criteria
Access provided upon request.

Learn more about this trial

Comprehensive Imaging Exam of Convalesced COVID-19 Patients

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