Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons (COVID ARC 19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- Inflammatory responses of cells in lung and circulation
研究概览
简要总结
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.
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详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Acutely illl subjects
COVID-19 subjects treated at the Clinical Center, followed through recovery and into convalescence
Recovered subjects
COVID-19 subjects who were treated at other hospitals, followed through recovery and into convalescence
结局指标
主要结局
Inflammatory responses of cells in lung and circulation
时间窗: From onset of illness in hospital through acute phase ( days 1 28 more or less 7
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.
次要结局
未报告次要终点