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Clinical Trials/NCT05920616
NCT05920616
Enrolling By Invitation
Not Applicable

Comprehensive Imaging Exam of Convalesced COVID-19 Patients

Johns Hopkins University1 site in 1 country210 target enrollmentOctober 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COVID-19
Sponsor
Johns Hopkins University
Enrollment
210
Locations
1
Primary Endpoint
Degree and extent of fibrosis
Status
Enrolling By Invitation
Last Updated
10 months ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
October 14, 2020
End Date
October 31, 2026
Last Updated
10 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with COVID-19 at any point starting March
  • 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)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Assessment of Perfusion(Analyzed within 6 months of study completion)

Study Sites (1)

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