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NCT04367831 · ClinicalTrials.gov registry record · Phase 4
Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19
A Phase 4 study of COVID-19 and Venous Thromboses, sponsored by Columbia University.
- Completed
- Registry status
- Phase 4
- Development phase
- 94
- Enrollment target
- 1
- Study location
NCT04367831: Completed Phase 4 study of COVID-19 and Venous Thromboses, sponsored by Columbia University.
NCT04367831 is a Phase 4 study of COVID-19 and Venous Thromboses that has completed, run by Columbia University. The registered enrollment target is 94 participants, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04367831, a Phase 4 study of COVID-19 and Venous Thromboses, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 94 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care but determining the dose of anticoagulation is based on physician preference. The investigators are conducting this study (a randomized trial with adaptive design employing cluster randomization) with the support of all of the ICUs to collect data in order to determine what should be the standard of care in terms of anticoagulation in these critically ill patients. The patients care will not be altered other than the choice of anticoagulation (both approved and used throughout the hospital as standard of care) based on the ICU bed they are assigned. Patient data will be collected until discharge.
Primary Outcome
Composite of being alive and without clinically-relevant venous or arterial thrombotic events at discharge from ICU (without transfer to another ICU or palliative care unit/hospice) or at 30 days (if ICU duration lasted 30 days or longer).
Conditions Studied
Interventions
- DRUG Enoxaparin Prophylactic Dose
- DRUG Heparin Infusion
- DRUG Heparin SC
- DRUG Enoxaparin/Lovenox Intermediate Dose
Study Locations (1)
New York
- Columbia University Medical Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2020-05-02 |
| Est. Completion | 2021-05-12 |
| Phase | Phase 4 |
What the finished NCT04367831 record still lists
NCT04367831 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 38,465-participant average among 298 other COVID-19 trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with COVID-19 appearing as the primary indexed condition, and to 4 interventions - of which Enoxaparin Prophylactic Dose is the first listed.
NCT04367831 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04367831 about?
NCT04367831 is a clinical study titled "Intermediate or Prophylactic-Dose Anticoagulation for Venous or Arterial Thromboembolism in Severe COVID-19". This study is being conducted to assess the effectiveness of intermediate versus prophylactic doses of anticoagulation (blood thinners) in patients critically ill with COVID-19 in the intensive care units (ICUs) throughout the hospital. Anticoagulation is part of the patient's usual standard of care...
What is the current status of trial NCT04367831?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 94 participants. The study started on 2020-05-02. Estimated completion is 2021-05-12.
What conditions does trial NCT04367831 study?
This clinical trial studies the following conditions: COVID-19, Venous Thromboses, Arterial Thrombosis.
What interventions are being tested in trial NCT04367831?
The interventions under investigation include: Enoxaparin Prophylactic Dose (DRUG), Heparin Infusion (DRUG), Heparin SC (DRUG), Enoxaparin/Lovenox Intermediate Dose (DRUG).
Who is sponsoring clinical trial NCT04367831?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04367831 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04367831's enrollment target sits among peer trials
94 208th of 298 higher than 91 of 298 other COVID-19 trials
participants (enrollment target), bucketed by value
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