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Completed
NCT04401436
COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
Conditions: Coronavirus Disease 2019
Sex: All
Ages: 18 Years – 99 Years
Healthy volunteers: No
Enrollment: 240
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Location: MedStar Georgetown University Hospital Washington D.C. District of Columbia
Summary
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.
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Eligibility Criteria
* 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 NC to \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 \
Source: ClinicalTrials.gov (NCT04401436). StuddyBuddy aggregates publicly available trial information.