Status:
COMPLETED
COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Coronavirus Disease 2019
Eligibility:
All Genders
18-99 years
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 f...
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 t...
Eligibility Criteria
Inclusion
- 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 and disposition of patients with COVID-19 in healthcare settings. Enrollment will occur at least 30 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.
Exclusion
Key Trial Info
Start Date :
May 22 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 24 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04401436
Start Date
May 22 2020
End Date
February 24 2025
Last Update
October 27 2025
Active Locations (3)
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1
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
2
MedStar Health Research Institute: Washington Hospital Medical Center
Washington D.C., District of Columbia, United States, 20010
3
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892