Trial Outcomes & Findings for Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism (NCT NCT04558125)

Last Updated: 2021-10-26

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

6 hours post TNK/placebo infusion

Results posted on

2021-10-26

Participant Flow

The study was terminated early and never unblinded. With only 2 subjects, statistical significance could never be demonstrated. Therefore, Arm/Group randomization information is not available.

Participant milestones

Participant milestones
Measure	All Study Participants 1. TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin). OR 2. Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).
Overall Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	All Study Participants 1. TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin). OR 2. Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).
Overall Study Death	1

Baseline Characteristics

Low-Dose Tenecteplase in Covid-19 Diagnosed With Pulmonary Embolism

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=2 Participants 1. TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin). OR 2. Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 hours post TNK/placebo infusion

Population: The study was terminated early and never unblinded. With only 2 subjects, statistical significance could never be demonstrated. Therefore, Arm/Group randomization information is not available.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 +/- 6 hours post TNK/placebo infusion.

Assessment of patient status using an ordinal scale will be recorded at baseline and once daily in the morning while hospitalized. Level 1: Discharged (or "ready for discharge" on ambient air or \< 2L suppl O2) Level 2: Non-ICU hospital ward (or "ready for hospital ward") not requiring suppl O2 Level 3: Non-ICU hospital ward (or "ready for hospital ward") requiring suppl O2 Level 4. ICU or non-ICU, requiring non-invasive ventilation or high-flow O2 Level 5. ICU, requiring intubation and mechanical ventilation Level 6: ICU, requiring ECMO or mechanical ventilation and additional organ support (e.g. vasopressors, renal replacement therapy) Level 7: Death

Outcome measures

Outcome data not reported

Adverse Events

All Study Participants

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	All Study Participants n=2 participants at risk 1. TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin). OR 2. Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	50.0% 1/2 • Number of events 1 • 30 days The study not unblinded. All data was entered in treatment fields.
Gastrointestinal disorders Gastrointestinal Bleeding	50.0% 1/2 • Number of events 1 • 30 days The study not unblinded. All data was entered in treatment fields.

Other adverse events

Other adverse events
Measure	All Study Participants n=2 participants at risk 1. TNKase (0.25 mg/kg) bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin). OR 2. Placebo-to-match-TNKase bolus as a sterile, lyophilized powder, diluted with 10mL sterile water, and administered as a 5-second bolus; AND standard of care anticoagulation therapy (enoxaparin or heparin).
Respiratory, thoracic and mediastinal disorders Epistaxis	50.0% 1/2 • Number of events 1 • 30 days The study not unblinded. All data was entered in treatment fields.
Respiratory, thoracic and mediastinal disorders Productive cough	50.0% 1/2 • Number of events 1 • 30 days The study not unblinded. All data was entered in treatment fields.
Cardiac disorders Hypotension	50.0% 1/2 • Number of events 1 • 30 days The study not unblinded. All data was entered in treatment fields.

Additional Information

Victor Tapson, MD

Cedars-Sinai Medical Center

Phone: 919-971-6441

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place