Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infe… (NCT04401449) | Clinical Trial Compass
CompletedNot Applicable
Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons
United States202 participantsStarted 2020-05-21
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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.
* …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Inflammatory responses of cells in lung and circulation
Timeframe: From onset of illness in hospital through acute phase ( days 1 28 more or less 7
Trial details
NCT IDNCT04401449
SponsorNational Institutes of Health Clinical Center (CC)