Comprehensive Imaging Exam of Convalesced COVID-19 Patients

NCT05920616 | Enrolling By Invitation

• 1 other identifier: IRB00252436
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; COVID Long-Haul

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assessment of Perfusion

  Analyzed within 6 months of study completion

Study Arms (2)

Hospitalized

OTHER

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

Other: Magnetic Resonance Imaging; Other: Ultra-High Resolution Computed Tomography (CT) Scan

Non-Hospitalized

OTHER

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

Other: Magnetic Resonance Imaging; Other: Ultra-High Resolution Computed Tomography (CT) Scan

Interventions

Magnetic Resonance Imaging OTHER

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

Hospitalized; Non-Hospitalized

Ultra-High Resolution Computed Tomography (CT) Scan OTHER

Completion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries.

Hospitalized; Non-Hospitalized

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18+
• Diagnosed with COVID-19 at any point starting March 2020.
• Subgroup A: hospitalized due to COVID-19 infection
• Subgroup B: non-hospitalized

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

COVID-19; Post-Acute COVID-19 Syndrome

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Joao Lima, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: June 27, 2023
• Study Start: October 14, 2020
• Primary Completion: February 25, 2025
• Study Completion (Estimated): October 31, 2026
• Last Updated: June 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

US (1)