NCT04404361

PRE-VENT Study in Hospitalized Patients With Severe COVID-19 With or Without Cancer

A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study of Pacritinib Plus Standard of Care Versus Placebo and Standard of Care in Hospitalized Patients With Severe COVID-19 With or Without Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: CTI BioPharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer.

Detailed description

This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of pacritinib in hospitalized patients with severe COVID-19 with or without cancer. Severe COVID-19 is defined as confirmed disease in patients who are hospitalized with hypoxia (blood oxygen saturation \[SpO2\] ≤93% on room air at sea level), respiratory rate \>30, arterial oxygen partial pressure \[PaO2\]/ fraction of inspired oxygen \[FiO2\] \<300, or lung infiltrates \>50% but do not require IMV. Patients will be randomized 1:1 to receive pacritinib (400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC or placebo + SOC. Assigned treatment will continue for up to Day 14 or until the patient experiences intolerable adverse events (AEs), withdraws consent, or initiates another investigational therapy or until the study is terminated. Assigned therapy may be given for an additional 7 days (for a total of 21 days) with the approval of the Medical Monitor if, in the opinion of the investigator, the patient's clinical signs and symptoms are improving and the potential benefit outweighs the potential risk.In the event of hospital discharge, patients will complete treatment with the assigned therapy as an outpatient.

Conditions

• COVID19
• COVID-19
• COVID

Interventions

Type	Name	Description
DRUG	Pacritinib	100 mg capsules
DRUG	Placebo	Placebo capsules matching pacritinib 100 mg capsules

Timeline

• Start date: 2020-05-22
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2020-05-27
• Last updated: 2024-06-05
• Results posted: 2024-06-05

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study