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NCT04401436 · ClinicalTrials.gov registry record
COVID-19 Associated Lymphopenia Pathogenesis Study in Blood
A clinical trial of Coronavirus Disease 2019, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 240
- Enrollment target
- 3
- Study locations
NCT04401436: Completed study of Coronavirus Disease 2019, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT04401436 is a study of Coronavirus Disease 2019 that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 240 participants, below the 413-participant average among 4 other Coronavirus Disease 2019 trials with a reported enrollment target (42% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04401436, a study of Coronavirus Disease 2019, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 240 participants
- Enrollment target
- 3
- Study locations
Study 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. ...
Primary Outcome
To characterize lymphopenia and immunologic phenotypes and inflammatory responses including inflammasome responses and coagulopathy in patients with COVID-19.
Conditions Studied
Study Locations (3)
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
- MedStar Health Research Institute: Washington Hospital Medical Center - Washington D.C.
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 240 participants |
| Start Date | 2020-05-22 |
| Est. Completion | 2025-02-24 |
What the finished NCT04401436 record still lists
NCT04401436 is an observational study that tracks outcomes without assigning an intervention. The registered 240 participants enrollment target is mid-sized for trials with a published cap, below the 413-participant average among 4 other Coronavirus Disease 2019 trials with a reported enrollment target (42% lower).
The record links to 1 condition, with Coronavirus Disease 2019 appearing as the primary indexed condition, and to 0 interventions.
NCT04401436 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT04401436 about?
NCT04401436 is a clinical study titled "COVID-19 Associated Lymphopenia Pathogenesis Study in Blood". 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,...
What is the current status of trial NCT04401436?
This trial is currently completed. The enrollment target is 240 participants. The study started on 2020-05-22. Estimated completion is 2025-02-24.
What conditions does trial NCT04401436 study?
This clinical trial studies the following conditions: Coronavirus Disease 2019.
Who is sponsoring clinical trial NCT04401436?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04401436 being conducted?
This trial has 3 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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