Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons

Overview

Background:

COVID-19 virus infection differs among people. Some people have no or mild symptoms. For others, COVID-19 is life threatening and causes damage to the body s organs. Researchers want to better understand the virus to learn how to kill it.

Objective:

To understand how the COVID-19 virus causes wide differences in how sick one can become from the infection.

Eligibility:

People ages 18-80 with COVID-19 infection

Design:

Participants will be screened with a review of their medical records.

Participants who enter the study at the beginning of their COVID-19 infection will stay in the hospital until they are healthy enough to go home. Those who enter after they have recovered may need to stay in the hospital 1-2 nights to perform the study tests.

Participants will have MRI and CT scans of the brain, heart, and lungs. They will lie in a machine that takes pictures of the body. For the MRI, soft padding or a coil will be placed around their head and chest. They may receive a dye injected into a vein.

Participants will have an ultrasound of the kidneys and heart.

Participants will provide blood and urine samples. They will provide nasal swabs.

Participants will have a bronchoscopy. A thin tube will be placed through the nose or mouth into the airway. Saltwater will be squirted into the lungs and removed by suction.

Participants may provide a spinal fluid sample. A needle injected into the spinal canal will obtain fluid.

Participants will have lung and heart function tests.

At various points after recovery, participants will repeat many of these tests.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 1, 2024

Detailed Description

There is little sequential, methodically collected data on patients with COVID-19 that can be correlated with the severity of disease or the long-term sequelae. Such information is necessary to understand how to most logically intervene with directly acting antiviral agents and immunologic response modifiers. The variability of the clinical course of patients who may be asymptomatic throughout their clinical course to those patients who develop progressive multisystem organ failure represents a challenge to understand the host and viral factors that result in these dramatically different outcomes.

This protocol will enroll patients to the Clinical Center in a longitudinal study using granular clinical, laboratory, and imaging data including extensive pulmonary and cardiac functional assessments, neurologic evaluation, comprehensive immunologic evaluations, and innovative imaging. In patients with COVID-19 infection, linking sequential analysis of blood, urine and bronchoalveolar lavage with simultaneous cardiopulmonary imaging can provide novel insights into mechanisms associated with the initiation, progression and resolution of lung, cardiac and systemic inflammation. These mechanisms are presumed to be essential in the pathogenesis and survival from this infection. This information will help guide diagnostic and therapeutic innovation and assess long-term consequences of this infection.

Arms, Groups and Cohorts

  • Acutely illl subjects
    • COVID-19 subjects treated at the Clinical Center, followed through recovery and intoconvalescence
  • Recovered subjects
    • COVID-109 subjects who were treated at other hospitals, followed through recovery and into convalescence

Clinical Trial Outcome Measures

Primary Measures

  • Inflammatory responses of cells in lung and circulation
    • Time Frame: From onset of illness in hospital through acute phase ( days 1 28 more or less 7), at the time of resolution of infection ( day 28 more or less 7 to 6 weeks, andduring convalescence (6 months to 1 year after the infection)
    • Link inflammatory responses present in blood, urine and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain and kidneys) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.

Participating in This Clinical Trial

Inclusion Criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

Subjects within 1-28 days of documented COVID-19 infection for acute care:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 to 80 years
  • Only a minority of children and adolescents have been described as developing serious illness with COVID-19 infection. As such, this is not an age group at significant risk from complications due to this infection. Adults older than 80 years of age represent a group with the greatest risk of mortality from COVID-19 infection. The presence of significant co-morbidities requiring care that cannot be

provided at the CC would present a disadvantage to them to have their acute care provided for in the CC.

  • Documentation of positive SARSCoV-19 test by nucleic acid detection (COVID-19 infection , RT-PCR)
  • Ability of subject to understand and the willingness to sign a written informed consent document.

Subjects during recovery phase of the acute illness (day 28 and beyond) if care has been received at a facility outside of NIH:

  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged 18 to 80 years

Exclusion Criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnancy or lactation
  • Serious mental illness (e.g. schizophrenia, manic depression) that would limit the ability of the participant to participate willingly into the study.

–The conduct of the study requires participation in studies that may be unduly stressful (e.g. MRI, bronchoscopy).

  • Severe claustrophobia that would prohibit the conduct of imaging by MRI even if sedation is provided.
  • Patients requiring mechanical ventilation at an outside hospital prior to transfer. Transporting these patients adds risk to their care.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • National Institutes of Health Clinical Center (CC)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anthony F Suffredini, M.D., Principal Investigator, National Institutes of Health Clinical Center (CC)

References

CDC COVID-19 Response Team. Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) – United States, February 12-March 16, 2020. MMWR Morb Mortal Wkly Rep. 2020 Mar 27;69(12):343-346. doi: 10.15585/mmwr.mm6912e2.

Mao L, Jin H, Wang M, Hu Y, Chen S, He Q, Chang J, Hong C, Zhou Y, Wang D, Miao X, Li Y, Hu B. Neurologic Manifestations of Hospitalized Patients With Coronavirus Disease 2019 in Wuhan, China. JAMA Neurol. 2020 Apr 10. doi: 10.1001/jamaneurol.2020.1127. [Epub ahead of print]

Driggin E, Madhavan MV, Bikdeli B, Chuich T, Laracy J, Biondi-Zoccai G, Brown TS, Der Nigoghossian C, Zidar DA, Haythe J, Brodie D, Beckman JA, Kirtane AJ, Stone GW, Krumholz HM, Parikh SA. Cardiovascular Considerations for Patients, Health Care Workers, and Health Systems During the COVID-19 Pandemic. J Am Coll Cardiol. 2020 May 12;75(18):2352-2371. doi: 10.1016/j.jacc.2020.03.031. Epub 2020 Mar 19. Review.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.