Clinical trial NCT05920616: Comprehensive Imaging Exam of Convalesced COVID-19 Patients
Official title: Comprehensive Imaging Exam of Convalesced COVID-19 Patients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: COVID-19
COVID Long-Haul
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Canon Medical Systems, USA
First posted: 2023-06-27
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree and extent of fibrosis
timeFrame: Analyzed within 6 months of study completion
Secondary outcomes:
measure: Assessment of Perfusion
timeFrame: Analyzed within 6 months of study completion
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Medicine
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Joao Lima, MD
role: PRINCIPAL_INVESTIGATOR
References: