COVID-19NCT05920616
Comprehensive Imaging Exam of Convalesced COVID-19 Patients
A study testing Magnetic Resonance Imaging and Ultra-High Resolution Computed Tomography (CT) Scan in people with COVID-19 and COVID Long-Haul, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, COVID Long-Haul
- What is being tested?
- Magnetic Resonance Imaging and Ultra-High Resolution Computed Tomography (CT) Scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2020to 15 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18+
- Diagnosed with COVID-19 at any point starting March 2020.
- Subgroup A: hospitalized due to COVID-19 infection
- Subgroup B: non-hospitalized
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
About this study
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.
Read the 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.
- Conditions
- COVID-19, COVID Long-Haul
- Being tested
- Magnetic Resonance Imaging, Ultra-High Resolution Computed Tomography (CT) Scan
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.
Ultra-High Resolution Computed Tomography (CT) ScanOther
Completion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries.
| Study group | Role | What they receive |
|---|---|---|
| Hospitalized | Other | Participants who were hospitalized due to their COVID-19 illness. Receives: 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. Receives: Other: Magnetic Resonance Imaging; Other: Ultra-High Resolution Computed Tomography (CT) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree and extent of fibrosis
- MRI to assess degree and extent of fibrosis in the liver, lungs, brain, myocardium, and vascular systems
Measured: Analyzed within 6 months of study completion
Secondary outcomes (1)
Assessment of Perfusion
Ultra-High Resolution CT to assess the amount of perfusion to the lungs and heart.
Measured: Analyzed within 6 months of study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start14 Oct 2020
- Primary completion15 May 2026
- Study completion15 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Joao Lima, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920616
- Sponsor's protocol ID
- IRB00252436
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2023
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Imaging Exam of Convalesced COVID-19 Patients
- ClinicalTrials.gov ID
- NCT05920616
- Acronym / sponsor ID
- IRB00252436
- Conditions
- COVID-19, COVID Long-Haul
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 14 Oct 2020 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- 15 May 2026 (actual)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hospitalized | Other | Other: Magnetic Resonance Imaging, Other: Ultra-High Resolution Computed Tomography (CT) ScanParticipants who were hospitalized due to their COVID-19 illness. |
| Non-Hospitalized | Other | Other: Magnetic Resonance Imaging, Other: Ultra-High Resolution Computed Tomography (CT) ScanParticipants who had COVID-19 but did not require hospitalization secondary to their illness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18+
- Diagnosed with COVID-19 at any point starting March 2020.
- Subgroup A: hospitalized due to COVID-19 infection
- Subgroup B: non-hospitalized
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingCompletion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast. | Other | Hospitalized, Non-Hospitalized |
| Ultra-High Resolution Computed Tomography (CT) ScanCompletion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries. | Other | Hospitalized, Non-Hospitalized |
Primary outcome
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
1 secondary outcome
Assessment of Perfusion
Time frame: Analyzed within 6 months of study completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joao Lima, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging and Ultra-High Resolution Computed Tomography (CT) Scan in people with COVID-19 and COVID Long-Haul, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree and extent of fibrosis (time frame: Analyzed within 6 months of study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.