NCT04530604

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Gregory Yanik · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial will enroll participants that have pneumonia caused by the COVID-19 virus. During the study patients will receive 7 to up to 14 days of defibrotide. After completing the treatment, participants will have 30 day follow-up check-up to assess for adverse events and clinical status. This final assessment can be done virtually, by telephone or electronically (email) if the patient cannot be contacted by phone. No in-person visit is required. The hypothesis of this trial is that defibrotide therapy given to patients with severe SARS-CoV2 ARDS will be safe and associated with improved overall survival, within 28 days of therapy initiation.

Conditions

• COVID
• Sars-CoV2
• COVID-19
• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2020-10-01
• Primary completion: 2021-03-26
• Completion: 2021-04-09
• First posted: 2020-08-28
• Last updated: 2023-05-09
• Results posted: 2023-05-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study