Trial Outcomes & Findings for Tenecteplase in Patients With COVID-19 (NCT NCT04505592)

NCT ID: NCT04505592

Last Updated: 2023-04-06

Results Overview

The number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 13 participants
• Primary outcome timeframe: 28 Days
• Results posted on: 2023-04-06

Participant Flow

Patients were recruited in a tertiary academic hospital in New York City.

Participant milestones

Measure	Tenecteplase Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Overall Study STARTED	8	5
Overall Study COMPLETED	6	4
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Measure	Tenecteplase Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Overall Study Death	2	1

Baseline Characteristics

Tenecteplase in Patients With COVID-19

Baseline characteristics by cohort

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Total n=13 Participants Total of all reporting groups
Age, Continuous	67.5 years n=5 Participants	71 years n=7 Participants	69 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Body Mass Index (BMI)	35 kg/m^2 n=5 Participants	26 kg/m^2 n=7 Participants	31 kg/m^2 n=5 Participants
Hypertension	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Diabetes	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Coronary Artery Disease (CAD)	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Obstructive Sleep Apnea	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Respiratory Support Mechanical ventilation	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Respiratory Support high-flow nasal cannula (HFNC)	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Respiratory Support non-rebreather (NRB)	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Respiratory Support non-invasive positive pressure ventilation (NIPPV)	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Steroids	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Remdesivir	7 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants
P/F Ratio	80 Ratio n=5 Participants	87 Ratio n=7 Participants	83 Ratio n=5 Participants

PRIMARY outcome

Timeframe: 28 Days

The number of patients free of respiratory failure defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation at 28 days

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Participants Free of Respiratory Failure	5 Participants	2 Participants

PRIMARY outcome

Timeframe: 28 days

Safety as assessed by number of participants with occurrences of intracranial bleeding or major bleeding

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Participants With Occurrences of Bleeding	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 14 days

Number of patients who expired in the hospital within the first 14 days of their participation in the study

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Participants With In-hospital Deaths at 14 Days	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Number of participants who expired by 28 days/end of study

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Participants With Death at 28 Days	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Number of ventilator-free days in 28 days period

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Ventilator-free Days	18 days Interval 3.0 to 28.0	19 days Interval 9.0 to 28.0

SECONDARY outcome

Timeframe: 28 days

Respiratory failure-free defined as not requiring high flow nasal cannula, non-rebreather, noninvasive positive pressure ventilation, or mechanical ventilation. Number of respiratory failure-free days in 28 days period.

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Respiratory Failure-free Days	0.5 days Interval 0.0 to 3.0	3 days Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: 28 days

Number of vasopressor-free days over 28 days period

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Vasopressor-free Days	9 days Interval 4.6 to 18.5	9 days Interval 9.0 to 18.0

SECONDARY outcome

Timeframe: 24 hours and 72 hours

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Vasopressor Doses at 24 Hours 24 hours	0 doses	0 doses
Number of Vasopressor Doses at 24 Hours 72 hours	0 doses	0 doses

SECONDARY outcome

Timeframe: 24 hours and 72 hours

The P/F ratio equals the arterial pO2 ("P") from the ABG divided by the FIO2 ("F") - the fraction (percent) of inspired oxygen that the patient is receiving expressed as a decimal (40% oxygen = FIO2 of 0.40).

Ratio of arterial pO2 over fraction of inspired oxygen that the person is receiving.

Normal P/F Ratio is ≥ 400.

300 to 200 is considered mild ARDS

200 to 100 is considered moderate ARDS

Anything below 100 is considered severe ARDS.

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
P/F Ratio 24 hours	89 Ratio Interval 68.0 to 92.0	97 Ratio Interval 89.0 to 146.0
P/F Ratio 72 hours	89 Ratio Interval 63.0 to 91.0	78 Ratio Interval 77.0 to 137.0

SECONDARY outcome

Timeframe: 28 days

Number of days the patient spent outside the ICU

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of ICU-free Days	1 days Interval 1.0 to 7.0	1 days Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: up to 29 days

Length of time the patient spent in the hospital, including ICU

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Hospital Length of Stay	11 days Interval 7.8 to 29.0	13 days Interval 12.0 to 29.0

SECONDARY outcome

Timeframe: 28 days

Number of patients who experienced renal failure during the course of the study

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Participants With New-onset Renal Failure	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 28 days

Number of patients who underwent renal replacement treatment for their renal failure

Outcome measures

Measure	Tenecteplase n=8 Participants Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 Participants Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Number of Participants With Need for Renal Replacement Therapy	0 Participants	2 Participants

Adverse Events

Tenecteplase

Serious events: 4 serious events

Other events: 3 other events

Deaths: 2 deaths

Placebo

Serious events: 4 serious events

Other events: 2 other events

Deaths: 1 deaths

Serious adverse events

Measure	Tenecteplase n=8 participants at risk Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 participants at risk Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Cardiac disorders Cardiogenic shock	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days
Cardiac disorders ST Elevation Myocardial Infarction (STEMI)	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days
Respiratory, thoracic and mediastinal disorders Worsening respiratory failure	12.5% 1/8 • 28 days	60.0% 3/5 • 28 days
Blood and lymphatic system disorders Large retroperitoneal hematoma with hgb drop	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days
Respiratory, thoracic and mediastinal disorders Intubation	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days
Blood and lymphatic system disorders Hemorrhagic shock	0.00% 0/8 • 28 days	20.0% 1/5 • 28 days
General disorders Death	12.5% 1/8 • 28 days	20.0% 1/5 • 28 days
Blood and lymphatic system disorders Compartment syndrome	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days

Other adverse events

Measure	Tenecteplase n=8 participants at risk Tenecteplase 0.25 mg/kg (maximum dose of 25 mg) And received concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.	Placebo n=5 participants at risk Patients received placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
Renal and urinary disorders Renal failure	12.5% 1/8 • 28 days	20.0% 1/5 • 28 days
Blood and lymphatic system disorders Decreased hemoglobin	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days
Blood and lymphatic system disorders Mild oral bleeding	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days
Renal and urinary disorders Acute kidney injury	12.5% 1/8 • 28 days	20.0% 1/5 • 28 days
Blood and lymphatic system disorders Bleeding from mouth and wrist	12.5% 1/8 • 28 days	0.00% 0/5 • 28 days

Additional Information

Dr. Hooman Poor

Icahn School of Medicine at Mount Sinai

Phone: (212) 241-5656

Email: hooman.poor@mountsinai.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place