Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

MedStar Health Research Institute /MedStar Washington Hospital Center
Washington, District of Columbia 20010
Contact:
Christopher Barnett, M.D.
202-877-3321

More Details

Status
Recruiting
Sponsor
National Institutes of Health Clinical Center (CC)

Study Contact

Natural History COVID Study (COVID ARC 1
Not Listed
nathx_covid@nih.gov

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.