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

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ClinicalTrials.gov Identifier: NCT04401436
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : January 7, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Brief 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.

...


Condition or disease
Corona Virus Disease 2019

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Associated Lymphopenia Pathogenesis Study in Blood (CALYPSO)
Actual Study Start Date : May 22, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Group/Cohort
COVID 19 patients
Study participants will be adults who either have COVID-19 or who have recently recovered from the disease(recovered per Centers for Disease Control and Prevention guidelines).



Primary Outcome Measures :
  1. Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery. [ Time Frame: Throughout the study ]
    To characterize lymphopenia and immunologic phenotypes and inflammatory responses including inflammasome responses and coagulopathy in patients with COVID-19.


Secondary Outcome Measures :
  1. Evaluation of inflammatory pathways that may contribute to COVID-19 disease pathogenesis. [ Time Frame: Throughout the study ]
    1. Correlation of lymphopenia, immunologic phenotypes, and inflammatory responses with clinical outcomes. 2. Characterization of complement activation in patients with COVID-19. 3. Evaluation of activationinduced cell death and activated T cell autonomous death through measurement of intracellular reactive oxygen species in monocyte, natural killer (NK), and T cell subsets in peripheral blood and correlation with double stranded (ds)-DNA damage ( >=-H2AX), FAS/FasL, BCL-2, caspase-1 activation, and activation-induced proliferation. 4. Evaluation of homing receptors to lymphoid, skin, and mucosal surfaces on B and T cells and correlate with ACE2, bradykinin, and homing chemokine levels.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
COVID 19 positive and recovered patients from inpatient settings at the NIH CC and Georgetown University Medical Center, and the local community for COVID 19 recovered patients.
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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04401436


Contacts
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Contact: Irini Sereti, M.D. (301) 496-5533 isereti@niaid.nih.gov

Locations
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United States, District of Columbia
MedStar Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20007
Contact: Princy Kumar, M.D.    202-444-0086    kumarp@gunet.georgetown.edu   
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Irini Sereti, M.D. National Institute of Allergy and Infectious Diseases (NIAID)
Additional Information:
Publications:
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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT04401436    
Other Study ID Numbers: 200111
20-I-0111
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: January 7, 2021
Last Verified: January 4, 2021
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
SARS-CoV-2
Lymphopenia
Coagulapathy
Cytokines
Additional relevant MeSH terms:
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Virus Diseases
Lymphopenia
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases