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NCT04558125 · ClinicalTrials.gov registry record · Phase 4
Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism
A Phase 4 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 4
- Development phase
- 2
- Enrollment target
NCT04558125 is a Phase 4 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 2 participants.
The verdict
NCT04558125, a Phase 4 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 2 participants
- Enrollment target
Study Summary
* There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. * These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. * When DIC is associated with COVID-19, it predicts a very poor prognosis. * This study will evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. * Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. * The study will generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients
Interventions
- DRUG Placebo
- DRUG Enoxaparin
- DRUG TNKase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2020-09-08 |
| Est. Completion | 2021-08-08 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04558125
The ClinicalTrials.gov registry entry for NCT04558125 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04558125 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04558125 about?
NCT04558125 is a clinical study titled "Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism". * There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by ...
What is the current status of trial NCT04558125?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 2 participants. The study started on 2020-09-08. Estimated completion is 2021-08-08.
What interventions are being tested in trial NCT04558125?
The interventions under investigation include: Placebo (DRUG), Enoxaparin (DRUG), TNKase (DRUG).
Who is sponsoring clinical trial NCT04558125?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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