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NCT04441996 · ClinicalTrials.gov registry record · Phase 4
Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity
A Phase 4 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT04441996: Completed Phase 4 study, sponsored by Emory University.
NCT04441996 is a Phase 4 study that has completed, run by Emory University. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04441996, a Phase 4 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
Many patients with Coronavirus Disease 2019 (COVID-19) have atypical blood clots. These blood clots can occur in either veins or arteries and be large, like in stroke or heart attack, or very tiny, called microthrombi. Some patients with COVID-19 even have blood clots despite being on anti-clotting medications. Blood with increased viscosity does not flow through the body normally, in the same way that syrup, a highly viscous liquid, and water, a minimally viscous liquid, flow differently. The researchers believe that hyperviscosity may contribute to blood clots and organ damage seen in patients with severe COVID-19. Plasma exchange removes a patient's plasma, which contains the large sticky factors that the researchers believe are increasing viscosity, and replaces it with plasma from healthy donors. In addition to providing important information about plasma exchange as a treatment in COVID-19 for patients, this study will provide data to justify resource and staffing decisions. This study will enroll 20 participants who are critically ill from COVID-19. Participants will be randomized to receive therapeutic plasma exchange (TPE) or standard of care (SOC).
Primary Outcome
Plasma viscosity is measured in centipoise (cP). The normal range is 1.4 - 1.8 cP and measurements above this range indicate increased viscosity.
Interventions
- OTHER Standard of care
- BIOLOGICAL Therapeutic plasma exchange (TPE)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-07-17 |
| Est. Completion | 2021-03-18 |
| Phase | Phase 4 |
What the finished NCT04441996 record still lists
NCT04441996 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Standard of care is the first listed.
NCT04441996 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04441996 about?
NCT04441996 is a clinical study titled "Therapeutic Plasma Exchange for COVID-19-associated Hyperviscosity". Many patients with Coronavirus Disease 2019 (COVID-19) have atypical blood clots. These blood clots can occur in either veins or arteries and be large, like in stroke or heart attack, or very tiny, called microthrombi. Some patients with COVID-19 even have blood clots despite being on anti-clotting ...
What is the current status of trial NCT04441996?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2020-07-17. Estimated completion is 2021-03-18.
What interventions are being tested in trial NCT04441996?
The interventions under investigation include: Standard of care (OTHER), Therapeutic plasma exchange (TPE) (BIOLOGICAL).
Who is sponsoring clinical trial NCT04441996?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04441996's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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