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Completed

NCT Number: NCT05920616

Comprehensive Imaging Exam of Convalesced COVID-19 Patients

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.

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Key information

Conditions

COVID-19 COVID Long-Haul Chronic Disease Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral Post-Acute COVID-19 Syndrome Post-Infectious Disorders RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Other

Completion of Magnetic Resonance Imaging of the brain, heart, lungs, and liver with and without contrast.

Ultra-High Resolution Computed Tomography (CT) Scan

Other

Completion of a high resolution CT scan of the lungs and high resolution CT of the coronary arteries.

Primary outcomes

  1. 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

  1. Assessment of Perfusion

    Time frame: Analyzed within 6 months of study completion

    Ultra-High Resolution CT to assess the amount of perfusion to the lungs and heart.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Canon Medical Systems, USA

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jun 27, 2023
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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