Comprehensive Imaging Exam of Convalesced COVID-19 Patients

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: COVID-19; COVID Long-Haul
• Intervention / Treatment: Other: Magnetic Resonance Imaging; Other: Ultra-High Resolution Computed Tomography (CT) Scan

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 Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree and extent of fibrosis	- MRI to assess degree and extent of fibrosis in the liver, lungs, brain, myocardium, and vascular systems	Analyzed within 6 months of study completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Perfusion	Ultra-High Resolution CT to assess the amount of perfusion to the lungs and heart.	Analyzed within 6 months of study completion

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Canon Medical Systems, USA
• Investigators: Principal Investigator: Joao Lima, MD, Johns Hopkins School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2020
• Primary Completion (Actual): February 25, 2025
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: June 23, 2023
• First Submitted That Met QC Criteria: June 23, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 16, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19
• Other Study ID Numbers: IRB00252436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No