- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04401449
Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons
Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (COVID ARC 19)
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 Overview
Status
Conditions
Detailed Description
Study Description: This protocol will enroll patients within a 50 mile radius of Bethesda, Maryland, to the Clinical Center in a longitudinal study using granular clinical observations including pulmonary and cardiac functional assessments, comprehensive immunologic evaluations, and innovative imaging. Sequential analysis of blood, bronchoalveolar lavage, and spinal fluid, with simultaneous serial imaging can provide insights into mechanisms associated with the initiation, progression and resolution of organ dysfunction and systemic inflammation due to COVID-19 infection.
Objectives:
Primary objective:
To link inflammatory responses present in blood, bronchoalveolar lavage, spinal fluid, and with imaging of COVID-19 target organs (lungs, heart and brain) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
Secondary objectives
Assess the long-term effects of COVID-19 infection on immunologic, neurologic, cardiac and pulmonary function
Endpoints:
- Measure inflammatory responses present in blood, bronchoalveolar lavage, and spinal fluid during the course of COVID-19 infection
- Obtain imaging of target organs during the course of COVID-19 infection
- Evaluate long-term effects of COVID-19 infection on immunologic, cardiac, pulmonary and neural function
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Anthony F Suffredini, M.D.
- Phone Number: (301) 496-9320
- Email: asuffredini@mail.nih.gov
Study Contact Backup
- Name: Doris Z Swaim, R.N.
- Phone Number: (301) 827-9716
- Email: doris.swaim@nih.gov
Study Locations
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District of Columbia
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Washington, District of Columbia, United States, 20010
- MedStar Washington Hospital Center
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- 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 +/- 7 days to 12 weeks) and convalescent phase (Week 13 up to 12 months), Year 2 convalescent phase (13 24 months), Year 3 convalescent phase (25 36 months) after recovery 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.
- Study participants will be invited to continue their participation in the study in years 2 and 3 based on the results of their tests from the first year and their willingness to continue for the two additional years. If test results of imaging, blood, pulmonary function and or bronchoscopy have returned to normal at the end of one year, the need for further cardiopulmonary testing will be assessed for each patient. Anyone who is invited to continue in the 2nd and 3rd years may discontinue their participation at any time.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation Study participants who are enrolled in the study and become pregnant during the enrollment period will be discontinued from further study participation. Exposure to radiation or radiographic contrast agents for research purposes .only would not be warranted for a pregnant woman and her fetus.
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.
- Cardiac pacemaker or implantable defibrillator unless it is safe for MRI
- Cerebral aneurysm clip unless it is safe for MRI
- Brain stimulator (e.g. TENS-Unit) unless it is safe for MRI
- Any type of ear implant unless it is safe for MRI
- Foreign body in the eye (e.g. metal shavings)
- Metal shrapnel or bullet
- Any implanted device (e.g. insulin pump, drug infusion device
- Patients requiring mechanical ventilation at an outside hospital prior to transfer. Transporting these patients adds risk to their care.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Acutely illl subjects
COVID-19 subjects treated at the Clinical Center, followed through recovery and into convalescence
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Recovered subjects
COVID-19 subjects who were treated at other hospitals, followed through recovery and into convalescence
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Link inflammatory responses present in blood and bronchoalveolar lavage with imaging of COVID-19 target organs (lungs, heart, brain ) during the earliest stages of infection and at subsequent time points as the infection and host responses evolve, through recovery.
|
From onset of illness in hospital through acute phase ( days 1 28 more or less 7
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anthony F Suffredini, M.D., National Institutes of Health Clinical Center (CC)
Publications and helpful links
General Publications
- 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.
- 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 Jun 1;77(6):683-690. doi: 10.1001/jamaneurol.2020.1127.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200113
- 20-CC-0113
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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