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

210 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Magnetic Resonance Imaging and Ultra-High Resolution Computed Tomography (CT) Scan for COVID-19 recovery?

Research shows that MRI and CT scans are effective in detecting brain injuries and abnormalities, which suggests they could be useful in monitoring and understanding recovery from COVID-19, especially if the virus affects the brain. ^{1 2 3 4 5}

Is Magnetic Resonance Imaging (MRI) safe for humans?

MRI contrast agents, like gadopentetate dimeglumine and gadoversetamide, have been used safely in millions of cases, with no significant safety concerns reported for people with normal kidney function. However, people with kidney problems should be cautious, as the elimination of these agents can be slower. ^{6 7 8 9 10}

How does the Comprehensive Imaging for COVID-19 Recovery treatment differ from other treatments for COVID-19?

This treatment is unique because it uses advanced MRI techniques, such as TrueFISP, low-field MRI, and Spiral-VIBE-UTE, to monitor lung recovery in COVID-19 patients without radiation exposure, unlike traditional CT scans. These MRI methods can detect functional lung changes and provide high-quality images, making them valuable for assessing post-COVID lung conditions. ^{11 12 13 14 15}

Research Team

Joao Lima, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Sweden pubmed.ncbi.nlm.nih.gov

Low field magnetic resonance imaging and computed tomography in the demonstration of posttraumatic brain abnormalities. [2016]

2. Netherlands pubmed.ncbi.nlm.nih.gov

A primer of neuroimaging analysis in neurorehabilitation outcome research. [2012]

3. Germany pubmed.ncbi.nlm.nih.gov

[Routine diagnosis and targeted diagnosis of craniocerebral trauma]. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Early magnetic resonance imaging of brainstem lesions after severe head injury. [2006]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of traumatic brain injury: a pictorial review. [2021]

6. United States 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. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Current status of MR imaging contrast agents: special report. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Molecular MRI of the Cardiovascular System in the Post-NSF Era. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety, and tolerability of gadoversetamide injection (OptiMARK) in subjects with central nervous system or liver pathology and varying degrees of renal function. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Phase II clinical trial of gadoteridol injection, a low-osmolal magnetic resonance imaging contrast agent. [2015]

11. Brazil pubmed.ncbi.nlm.nih.gov

Appearance of COVID-19 pneumonia on 1.5 T TrueFISP MRI. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Free-Breathing Low-Field MRI of the Lungs Detects Functional Alterations Associated With Persistent Symptoms After COVID-19 Infection. [2023]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Performance of spiral UTE-MRI of the lung in post-COVID patients. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Cardiopulmonary Imaging Utilization and Findings among Hospitalized COVID-19 Patients in Latin America: (From "RIMAC: Registry IMAging Cardiopulmonary among Hospitalized COVID-19 Patients in LATAM"). [2022]

15. Japan pubmed.ncbi.nlm.nih.gov

Ultra-high-resolution computed tomography can demonstrate alveolar collapse in novel coronavirus (COVID-19) pneumonia. [2021]