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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: Clinical Trial Phase 4 study, sponsored by Cedars-Sinai Medical Center.
NCT04558125 is a Phase 4 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 2 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
For example, a patient may start with a heart rate of 100 beats/min and systolic blood pressure of 100 mm Hg (shock index = 1) and after therapy there may be an improvement where the heart rate is 90 beats/min, with systolic blood pressure of 110 mm Hg (shock index of 0.81), an improvement of 19%. A normal shock index is between 0.5 and 0.7 in healthy 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 |
Why NCT04558125 stopped before completion
NCT04558125 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT04558125 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04558125's enrollment target sits among peer trials
2 1998th of 2000 higher than 1 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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