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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 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 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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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.

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

FieldValue
Enrollment Target 94 participants
Start Date 2020-05-02
Est. Completion 2021-05-12
Phase Phase 4

Sponsor

Columbia University

958 total trials

What the Registry Record Tells You About NCT04367831

The ClinicalTrials.gov registry entry for NCT04367831 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 55,214-participant average among 203 other COVID-19 trials with a reported enrollment target (100% lower). The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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