Comprehensive Imaging Exam of Convalesced COVID-19 Patients

Sponsor
Johns Hopkins University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05920616
Collaborator
Canon Medical Systems, USA (Industry)
210
1
2
72.5
2.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetic Resonance Imaging
  • Other: Ultra-High Resolution Computed Tomography (CT) Scan
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
210 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comprehensive Imaging Exam of Convalesced COVID-19 Patients
Actual Study Start Date :
Oct 14, 2020
Anticipated Primary Completion Date :
Oct 31, 2025
Anticipated Study Completion Date :
Oct 31, 2026

Arms and Interventions

Arm Intervention/Treatment
Other: Hospitalized

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

Other: Magnetic Resonance Imaging
Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.

Other: Ultra-High Resolution Computed Tomography (CT) Scan
Completion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries.

Other: Non-Hospitalized

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

Other: Magnetic Resonance Imaging
Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.

Other: Ultra-High Resolution Computed Tomography (CT) Scan
Completion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries.

Outcome Measures

Primary Outcome Measures

  1. Degree and extent of fibrosis [Analyzed within 6 months of study completion]

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

Secondary Outcome Measures

  1. Assessment of Perfusion [Analyzed within 6 months of study completion]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Johns Hopkins School of Medicine Baltimore Maryland United States 21205

Sponsors and Collaborators

  • Johns Hopkins University
  • Canon Medical Systems, USA

Investigators

  • Principal Investigator: Joao Lima, MD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT05920616
Other Study ID Numbers:
  • IRB00252436
First Posted:
Jun 27, 2023
Last Update Posted:
Jun 27, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2023