Comprehensive Imaging for COVID-19 Recovery

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Pregnancy, Heart failure, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial studies the long-term effects of COVID-19 on major organs like the lungs and heart using advanced imaging techniques, such as CT and MRI scans (Magnetic Resonance Imaging). Researchers aim to understand and measure any ongoing issues caused by the virus. The trial includes two groups: those hospitalized for COVID-19 and those who weren't. It suits adults diagnosed with COVID-19 since March 2020 who don’t have allergies to certain contrast agents used in imaging. As an unphased trial, this study offers a unique opportunity to contribute to vital research on the long-term impacts of COVID-19.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial investigators for more details.

What prior data suggests that these imaging techniques are safe for COVID-19 recovery studies?

Research shows that Magnetic Resonance Imaging (MRI) is generally safe and well-tolerated. Studies using MRI to examine the effects of COVID-19 on the brain and heart have not found major safety concerns with the MRI process itself. However, MRI requires lying still in a large machine, which some people find uncomfortable or claustrophobic.

Ultra-High Resolution Computed Tomography (CT) scans have been widely used in studies to examine the lungs and other organs affected by COVID-19. These scans are considered safe for most people. The main concern with CT scans is exposure to a small amount of radiation, but the amount used is generally low and safe for medical imaging.

Both MRI and CT scans have been important tools in studying COVID-19, with no significant safety issues reported. Always discuss any concerns with a healthcare provider before participating in a study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores advanced imaging techniques like Magnetic Resonance Imaging (MRI) and Ultra-High Resolution Computed Tomography (CT) scans to better understand COVID-19 recovery. Unlike standard care options that often rely on basic imaging or clinical observations, these high-tech scans provide detailed insights into lung and organ health post-COVID. By capturing ultra-clear images, researchers hope to uncover subtle changes that might be missed otherwise, potentially leading to better recovery strategies and improved long-term care for those affected by COVID-19.

What evidence suggests that this imaging study is effective for understanding COVID-19 recovery?

This trial will use both Magnetic Resonance Imaging (MRI) and Ultra-High Resolution Computed Tomography (CT) scans to study participants' recovery from COVID-19. Research has shown that MRI scans help identify effects on the heart and brain in COVID-19 survivors. One study found that MRI scans detected heart damage in these patients. Another study observed differences in brain scans between individuals with long COVID and those who fully recovered, suggesting potential long-term effects of the virus.

Ultra-High Resolution CT scans have played a crucial role in diagnosing and monitoring COVID-19. Research indicates that CT scans effectively identify lung damage and help doctors understand disease progression. This imaging is particularly useful when other tests, like RT-PCR, are unavailable or inconclusive. Participants in this trial will be grouped based on whether they were hospitalized or non-hospitalized during their COVID-19 illness, and both imaging techniques will assess their recovery. ^{3 4 6 7 8}

Who Is on the Research Team?

Joao Lima, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who had COVID-19, split into those hospitalized and not hospitalized. It's not for patients still on ventilators, those over 300 lbs due to MRI limits, with certain heart conditions or severe kidney issues (GFR <45), pregnant women, people allergic to contrast agents used in scans, with internal electrical devices like pacemakers, or severe claustrophobia.

Inclusion Criteria

You have been admitted to the hospital because of a COVID-19 infection.

Subgroup B: non-hospitalized

I was diagnosed with COVID-19 since March 2020.

Exclusion Criteria

You weigh more than 300 pounds, which is too heavy for the MRI table.

I do not have any current severe illnesses.

I have an irregular heartbeat or a severe block in my heart's electrical signals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Assessment

Participants undergo CT and MRI imaging to assess chronic consequences of COVID-19 on major organ systems

6 months

Multiple imaging sessions

Follow-up

Participants are monitored for safety and effectiveness after imaging assessments

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Resonance Imaging
• Ultra-High Resolution Computed Tomography (CT) Scan

Trial Overview

The study uses advanced imaging techniques - MRI and ultra-high resolution CT scans - to examine long-term organ damage in recovered COVID-19 patients. Participants will be compared with matched controls to understand the chronic effects of the virus on major organs.

How Is the Trial Designed?

Group I: Non-Hospitalized Experimental Treatment 2 Interventions

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

Group II: Hospitalized Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Canon Medical Systems, USA

Industry Sponsor

Trials

14

Recruited

1,300+

Published Research Related to This Trial

Gadopentetate dimeglumine (Gd-DTPA) has been safely used in over 45 million MRI procedures since its introduction in 1988, with adverse events (AEs) reported in less than 0.01% of cases, indicating a strong safety profile.

The analysis revealed that while serious AEs accounted for only 9.3% of reports, there were significant regional differences in AE reporting, with the U.S. reporting nearly double the AEs compared to Europe, highlighting the importance of ongoing pharmacovigilance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of utilization and pharmacovigilance based on spontaneous adverse event reporting of gadopentetate dimeglumine as a magnetic resonance contrast agent after 45 million administrations and 15 years of clinical use. Knopp, MV., Balzer, T., Esser, M., et al.[2015]

Two new molecular MRI agents have been approved for clinical use recently, and a third is in advanced clinical trials, indicating progress in the development of safer imaging options.

The review emphasizes the importance of prioritizing safety and efficacy in the design of molecular MRI agents, especially in light of past concerns like nephrogenic systemic fibrosis (NSF), which has seen no new cases reported since safety guidelines were implemented.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular MRI of the Cardiovascular System in the Post-NSF Era. Sosnovik, DE., Caravan, P.[2021]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10299552/

Transformative Effect of COVID-19 Pandemic on Magnetic ...

The aim of study was to investigate the transformative effect of the COVID-19 pandemic on magnetic resonance imaging (MRI) services in one tertiary

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This cohort study evaluates the presence of myocardial injury in unselected patients recently recovered from coronavirus disease 2019 ...

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cidrap.umn.edu

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MRI study spotlights impact of long COVID on the brain

A new study comparing magnetic resonance imaging (MRI) images of patients with long COVID, fully recovered COVID-19 survivors, and healthy controls shows ...

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Impact of the COVID-19 pandemic on cardiac magnetic ...

The COVID-19 pandemic led to a higher proportion of cardiac MRI examinations for suspected myocarditis but a reduced positivity rate.

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sciencedirect.com

sciencedirect.com/science/article/pii/S2213158224000287

On the merits and potential of advanced neuroimaging ...

Diffusion tensor imaging revealed lower fractional anisotropy (FA) in recovered COVID-19 ... COVID-19 survivors: a multimodal magnetic resonance imaging study.

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pmc.ncbi.nlm.nih.gov

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3.2. Brain MRI Findings. All the included studies considered brain lesions as possible consequences of COVID-19, without explicitly addressing other risk ...

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thelancet.com

thelancet.com/journals/lanwpc/article/PIIS2666-6065(24)00080-4/fulltext

Brain abnormalities in survivors of COVID-19 after 2-year ...

This study aimed to investigate the long-term neuroimaging effects of COVID-19 infection on brain functional activities using resting-state ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S0883944123002514

Brain magnetic resonance imaging findings six months ...

We studied long-term brain MRI findings in ICU-treated COVID-19 patients and compared them with findings in groups with less severe acute disease.