Comprehensive Imaging Exam of Convalesced COVID-19 Patients

June 8, 2026 updated by: Johns Hopkins University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Analyzed within 6 months of study completion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Analyzed within 6 months of study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canon Medical Systems, USA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joao Lima, MD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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