This study is currently recruiting participants.
Number
20-I-0111
Sponsoring Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 18 Years Max Age: N/A
Referral Letter Required
Yes
Population Exclusion(s)
Children
Keywords
SARS-CoV-2; Lymphopenia; Coagulopathy; Cytokines; Natural History
Recruitment Keyword(s)
None
Condition(s)
Coronavirus Disease 2019
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Allergy and Infectious Diseases
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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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: a. Group A, mild clinical presentation: asymptomatic to oxygen requirements <-4L nasal cannula (NC). b. Group B, moderate clinical presentation: oxygen requirements >4L NC to <=50% fraction of inspired oxygen (FiO2) on high-flow oxygen devices. c. 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. d. 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.
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:
a. Group A, mild clinical presentation: asymptomatic to oxygen requirements <-4L nasal cannula (NC).
b. Group B, moderate clinical presentation: oxygen requirements >4L NC to <=50% fraction of inspired oxygen (FiO2) on high-flow oxygen devices.
c. 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.
d. 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.
Principal Investigator
Referral Contact
For more information: