Clinical trial NCT04401436: COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
Official title: COVID-19-Associated Lymphopenia Pathogenesis Study in Blood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019
Keywords: SARS-CoV-2
Lymphopenia
Coagulopathy
Cytokines
Natural History
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2020-05-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

...

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 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.

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 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.

Primary outcomes:
measure: Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery.
timeFrame: Throughout the study
Secondary outcomes:
measure: Evaluation of inflammatory pathways that may contribute to COVID-19 disease pathogenesis.
timeFrame: Throughout the study
Other outcomes:
Locations:
city: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Washington
country: United States
facility: MedStar Health Research Institute: Washington Hospital Medical Center
state: District of Columbia
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Allergy and Infectious Diseases (NIAID)
name: Irini Sereti, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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