COVID-19 Associated Lymphopenia Pathogenesis Study in Blood (CALYPSO)

  • STATUS
    Recruiting
  • participants needed
    165
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
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Updated on 16 February 2024
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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.

...

Description

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 1-2 study visits to have blood drawn via venipuncture or available venous access, with optional leukapheresis, nasal and rectal swabs, and echocardiogram for recovered patients. 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.

Details
Condition Corona Virus Disease 2019
Age 18years - 100years
Clinical Study IdentifierNCT04401436
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Aged >=18 years
Diagnosis of COVID-19 via molecular assay or other commercial or public health assay
Meets one of the following criteria for COVID-19
Group A, mild clinical presentation: asymptomatic to oxygen requirements <-4L nasal cannula (NC)
Group B, moderate clinical presentation: oxygen requirements >4L NC to <=50% fraction of inspired oxygen (FiO2) on high-flow oxygen devices
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
Group D, recovered: meets CDC criteria for discontinuation of transmission-based precautions by either test-based strategy (resolution of fever, improvement in respiratory symptoms, negative results of an FDA emergency use authorized COVID-19 molecular assay from at least two consecutive nasopharyngeal swab specimens collected >= 24 hours apart) or non test-based strategy (ie, at least 3 days have passed since recovery [defined as resolution of fever and improvement in respiratory symptoms] and at least 7 days have passed since symptoms first appeared). Enrollment will occur after 30-60 days after the above criteria were met
Able to provide informed consent

Exclusion Criteria

Individuals meeting any of the following criteria will be excluded from study
participation
Documented history of hemoglobin from most recent blood draw <7g/dL if known
Any condition that, in the opinion of the investigator, contraindicates participation in this study
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