COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04558125

Victor E Tapson, MD

Not reported

2020-09-22

Terminated

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: male or non-pregnant female adult ≥18 years of age, but < 75 years of age at time of enrollment. laboratory-confirmed sars-cov-2 infection as determined by pcr, or other commercial or public health assay in any specimen < 28 days prior to randomization, or person under investigation (pui) of covid-19 with pulmonary infiltrates and elevated ferritin and crp level. acute intermediate-risk pulmonary embolism defined as: presence of acute pulmonary embolism confirmed by diagnostic imaging (computed tomographic angiography, ventilation-perfusion scan, or invasive pulmonary angiography) and presence of clot burden with at least one lobar artery involved or bilateral with at least segmental branches or unilateral clot in at least multiple segmental branches. subject (or legally authorized representative) provides written informed consent prior to the performance of any study procedures. in the investigator's judgement, patient has the ability to comply with the study protocol, and understands and agrees to comply with planned tnk bolus versus placebo.

anticipated transfer to another hospital (which is not a study site) within 72 hours allergy or contraindications to tnk contraindications to systemic anticoagulation active bleeding known significant bleeding risk (although recent exposure to aspirin or any other antiplatelet therapy is not an exclusion criterion). while there is no specific hemoglobin cut-off value for enrollment, investigators will gauge the severity / stability of the hgb and exclude patients deemed inappropriate. major gi or gu bleed within the past 3 weeks history of hemorrhagic stroke history of acute ischemic stroke in the last 90 days high-risk (massive) acute pe (pe associated with hypotension (systolic bp < 90 mmhg for > 15 min). pe associated with syncope and any degree of head trauma pe meeting criteria for intermediate-risk pe and thus for enrollment, but with clinical evidence of deterioration such that the investigator deems the patient not appropriate for enrollment. administration of thrombolytic agent within the previous 7 days pulmonary thrombectomy within the previous 30 days uncontrolled hypertension defined as systolic blood pressure >180 mm hg and/or diastolic blood pressure >110 mm hg at randomization severe ards (p/f ratio < 100) platelet count lower than 80,000/mm3 known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency; recent oral anticoagulant therapy with inr >1.7 arterial puncture at a non-compressible site within the past 5 days prior brain surgery severe trauma in the prior 2 weeks major surgery in the prior 2 weeks brain malignancy / metastases, brain tumor in past 5 years brain avm or ruptured aneurysm at any time acute myocardial infarction or history of myocardial infarction within the past 3 weeks or cardiac arrest during hospitalization cardiac tamponade lumbar puncture with in past 7 days known abdominal or thoracic aneurysm acute or chronic renal failure requiring dialysis chronic liver failure (acutely elevated liver function tests not an exclusion criterion) bacterial endocarditis at time of study entry seizure during pre-hospital course or during hospitalization for covid-19 currently on ecmo pregnancy, lactation or parturition within the previous 30 days patients, in whom, in the opinion of the investigator, are critically ill from concomitant comorbid cardiopulmonary disease, and unlikely to benefit. any other condition that the investigator felt would place the patient at increased risk if the investigational therapy were initiated previous enrollment in this study

2

Cedars-Sinai Medical Center

18

75

United States

Moderate/severe/critical disease at enrollment

5: Moderate/severe/critical disease at enrollment

2

Percent improvement in shock index (defined as heart rate divided by systolic blood pressure) 6 hours after the TNK/placebo bolus.

None

Phase 4

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