Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS)

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

October 1, 2020

Primary Completion Date

March 26, 2021

Study Completion Date

April 9, 2021

Conditions
COVIDSars-CoV2COVID-19Acute Respiratory Distress Syndrome
Interventions
DRUG

Defibrotide

"All patients will receive 25 milligram/kilogram/day (mg/kg/day) of defibrotide, given in 4 divided doses (approximately every 6 hours), each dose infused over 2-hours intravenously (IV).~The planned duration of study therapy is 7 days (while in the hospital), with the following qualifications:~* Patients who respond to study therapy prior to day 7 (able to discontinue oxygen) will discontinue study therapy at that earlier time point.~* Patients who have not responded to study therapy by day 7 of therapy, evidenced by \<20% reduction (or a worsening) of the amount of supplemental oxygen they are receiving, will discontinue study therapy at day 7.~* Patients who have evidence of a partial pulmonary response by day 7 (\>20% reduction in supplemental oxygen requirement, but still require supplemental oxygen) may elect to continue to receive study drug through an additional 7 days of study (total 14-day therapy course)."

Trial Locations (1)

48109

University of Michigan, Ann Arbor

Sponsors

Collaborators (1)

All Listed Sponsors
lead

Gregory Yanik

OTHER

collaborator

Jazz Pharmaceuticals

INDUSTRY