Background: COVID-19 is an acute respiratory syndrome. One symptom of COVID-19 is a reduction in the number of cells called lymphocytes in the blood. Lymphocytes are a type of white blood cell that fights infections. With fewer lymphocytes, the body cannot effectively fight back against SARS CoV-2, the virus that causes COVID-19. Researchers want to better understand how SARS-CoV-2 affects these blood cells. This information may give them ideas for new treatments. Objective: To learn more about how SARS-CoV-2 affects lymphocytes, the immune, and the blood clotting system. Eligibility: Adults age 18 and older who either currently have COVID-19 or have recently recovered from it Design: Participants will give a blood sample. For this, a needle is used to collect blood from an arm vein. For participants who have a central line, blood will be collected through that instead. Participants medical records related to COVID-19 will be reviewed. Participants who have recovered from COVID-19 will be asked to undergo leukapheresis to collect white blood cells. For this, blood is taken from a needle placed in one arm. A machine separates out the white blood cells. The rest of the blood is returned to the participant through a needle placed in the other arm. This takes about 2-3 hours. Recovered participants may have material collected from inside the nostrils and/or rectum. This is done by gently rubbing the area with a sterile cotton swab. Recovered participants may have an echocardiogram to look at their heart. For this, a small probe is held against the chest to get pictures of the heart from different angles. This takes less than 30 minutes. Participation lasts 1-2 days on most cases and may be split in a few visits for recovered patients if leukapheresis and echocardiogram are done. ...
Coronavirus disease 2019 (COVID-19) is an acute respiratory syndrome caused by the novel
coronavirus severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). The emergence of
SARS-CoV-2 has led to a pandemic with a wide range of manifestations. One of the hallmarks of
severe illness is the presence of elevated levels of inflammatory biomarkers, coagulopathy,
and lymphopenia. Lymphopenia is a robust and consistent predictor of mortality in COVID-19.
Understanding the intersection of inflammation, complement activation, endothelial damage,
and coagulation is critical to a better understanding of COVID-19 pathogenesis.
This is a multisite study that will conducted at the National Institutes of Health Clinical
Center and other local hospitals. We will recruit patients with mild to severe COVID-19, as
well as patients who have recently recovered from the disease. Participants will have blood
drawn via venipuncture or available venous access and optional nasal and/or rectal swabs,
with optional leukapheresis and echocardiogram for recovered patients. Leftover clinical
specimens may also be used for research. Blood will be used for genetic testing, lymphocyte
phenotyping, soluble biomarker analysis, and other research tests. Clinical and laboratory
data from routine care
(eg, basic demographic information, vital signs, medications, clinical labs, and radiologic
imaging) will also be collected and up to two follow up visits may be done for clinical
purposes. Participants may re-enroll in the study after recovery from infection as recovered
participants or if they experience a new infection.
- INCLUSION CRITERIA:
1. Aged >=18 years.
2. Diagnosis of COVID-19 via molecular assay or other commercial or public health
assay.
3. Meets one of the following criteria for COVID-19:
1. Group A, mild clinical presentation: asymptomatic to oxygen requirements
<-4L nasal cannula (NC).
2. Group B, moderate clinical presentation: oxygen requirements >4L NC to <=50%
fraction of inspired oxygen (FiO2) on high-flow oxygen devices.
3. Group C, severe clinical presentation: non-invasive ventilation with oxygen
requirements >50% FiO2 on high-flow oxygen devices, any other modality of
non-invasive ventilation, or mechanical ventilation.
4. Group D, recovered: meets CDC criteria for discontinuation of
transmission-based precautions and disposition of patients with COVID-19 in
healthcare settings. Enrollment will occur at least 30 days after the above
criteria were met.
4. Able to provide informed consent.
EXCLUSION CRITERIA:
Individuals meeting any of the following criteria will be excluded from study
participation:
1. Documented history of hemoglobin from most recent blood draw <7g/dL if known.
2. Any condition that, in the opinion of the investigator, contraindicates participation
in this study.
MedStar Georgetown University Hospital
Washington, District of Columbia, United States
MedStar Health Research Institute: Washington Hospital Medical Center
Washington, District of Columbia, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, United States
Elizabeth Laidlaw, P.A.-C
(301) 827-9717
elizabeth.laidlaw@nih.gov
Irini Sereti, M.D.
(301) 496-5533
isereti@niaid.nih.gov
Irini Sereti, M.D., Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)