The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comprehensive Imaging Exam of Convalesced COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05920616
Recruitment Status : Enrolling by invitation
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Collaborator:
Canon Medical Systems, USA
Information provided by (Responsible Party):
Johns Hopkins University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
COVID-19 COVID Long-Haul Other: Magnetic Resonance Imaging Other: Ultra-High Resolution Computed Tomography (CT) Scan Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 14, 2020
Estimated Primary Completion Date : October 31, 2025
Estimated Study Completion Date : October 31, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Degree and extent of fibrosis [ Time Frame: 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 [ Time Frame: Analyzed within 6 months of study completion ]
    Ultra-High Resolution CT to assess the amount of perfusion to the lungs and heart.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920616


Locations
Layout table for location information
United States, Maryland
Johns Hopkins School of Medicine
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Canon Medical Systems, USA
Investigators
Layout table for investigator information
Principal Investigator: Joao Lima, MD Johns Hopkins School of Medicine
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05920616    
Other Study ID Numbers: IRB00252436
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
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.
Access Criteria: Access provided upon request.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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