Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

May 14, 2020

Primary Completion Date

March 21, 2021

Study Completion Date

September 30, 2021

Conditions
Severe Acute Respiratory SyndromeRespiratory FailureAcute Respiratory Distress Syndrome
Interventions
DRUG

Alteplase 50 MG [Activase]

Patients randomized to Alteplase-50 group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours, given as a 10 mg push followed by the remaining 40 mgs over a total time of 2 hrs. Immediately following the Alteplase infusion, 5000 units (U) of unfractionated heparin (UFH) will be delivered and the heparin drip will be continued to maintain the activated partial thromboplastin time (aPTT) at 60-80sec (2.0 to 2.5 times the upper limit of normal). Re-bolusing of Alteplase, at the same dose, is permitted in the Alteplase-50 intervention group in those patients who show an initial transient response (\>20% improvement of PaO2/FiO2 over pre-infusion of Alteplase at any of the measurements at 2, 6, 12 or 18 hours, but \<50% improvement of PaO2/FiO2 at 24 hours after randomization); the repeat dose will be given between 24 and 36 hours after the initial Alteplase administration.

DRUG

Alteplase 50 MG [Activase]

wed by the remaining 40 mgs over a total time of 2 hrs. Immediately following this initial Alteplase infusion, we will initiate a drip of 2 mg/hr Alteplase over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of 500 units per hour (U/hr) heparin during the Alteplase drip. After this, heparin dose will be increased slowly to maintain aPTT between 60 and 80 sec, titrated per attending's discretion.

Trial Locations (9)

11040

Long Island Jewish Medical Center, New York

33407

St. Mary's Medical Center, West Palm Beach

75203

Methodist Dallas Medical Center, Dallas

77030

Ben Taub Hospital, Houston

80045

University of Colorado, Denver, Aurora

80204

Denver Health Medical Center, Denver

80206

National Jewish Health, Denver

92037

Scripps Memorial Hospital La Jolla, La Jolla

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Genentech, Inc.

INDUSTRY

collaborator

University of Colorado, Denver

OTHER

collaborator

National Jewish Health

OTHER

collaborator

Beth Israel Deaconess Medical Center

OTHER

collaborator

Long Island Jewish Medical Center

OTHER

collaborator

Scripps Health

OTHER

collaborator

St. Mary's Medical Center

OTHER

collaborator

University of Miami

OTHER

collaborator

Ben Taub Hospital

OTHER

collaborator

The Methodist Hospital Research Institute

OTHER

lead

Denver Health and Hospital Authority

OTHER