Status:
COMPLETED
Cardiopulmonary Inflammation and Multi-System Imaging During the Clinical Course of COVID-19 Infection in Asymptomatic and Symptomatic Persons
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Acute and Long Term Effects of COVID-19 on Systemic Inflammation
Acute and Long Term Effects of COVID-19 on Lung Function
Eligibility:
All Genders
18-80 years
Brief 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 b...
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 pulmo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04401449
Start Date
May 21 2020
End Date
August 31 2023
Last Update
January 9 2026
Active Locations (2)
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1
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
2
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892