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

Part of paid clinical trials in Orange, California.

Sponsor
CTI BioPharma
Study ID
NCT04404361
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pacritinib — DRUG
    100 mg capsules
  • Placebo — DRUG
    Placebo capsules matching pacritinib 100 mg capsules

Study Details

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.

Key Dates

Start date
May 22, 2020
Status verified
May 2024
Primary completion
Sep 21, 2021
Completion
Sep 21, 2021

Study Design

Enrollment
200 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pacritinib and SOC
    Pacritinib 400 mg once daily \[QD\] on Day 1, then 200 mg twice daily \[BID\] from Day 2 to Day 14) + SOC
  • Placebo Comparator: Placebo and SOC
    4 capsules once daily \[QD\] on Day 1, then 2 capsules twice daily \[BID\] from Day 2 to Day 14) + SOC

Primary Outcome Measure

Percentage of Participants With Progression to IMV and/or ECMO or Death [ Time Frame: Baseline to Day 28 ]

Locations (21)

FacilityCityStateZIPSite coordinators
St. Jude Hospital Yorba Linda dba St. Joseph Heritage HealthcareOrangeCalifornia92868-
Ascension St. Vincent's Riverside HospitalJacksonvilleFlorida32204-
Grady Memorial HospitalAtlantaGeorgia30303-
St. Vincent Medical Group, IncIndianapolisIndiana46220-
St. Agnes HealthcareBaltimoreMaryland21229-
Brigham and Women's HospitalBostonMassachusetts02115-
University of MichiganAnn ArborMichigan48109-
Ascension St. John HospitalDetroitMichigan48236-
Ascension Providence Hospital - Novi CampusNoviMichigan48374-
Providence Cancer InstituteSouthfieldMichigan48075-
Atlantic Melanoma CenterMorristownNew Jersey07960-
Overlook Medical CenterMorristownNew Jersey07960-
Chilton Medical CenterPompton PlainsNew Jersey07444-
Mount Sinai Medical CenterNew YorkNew York10029-
The Carl and Edyth Lindner Center for Research and Education at The Christ HospitalCincinnatiOhio45219-
St. John Medical CenterTulsaOklahoma74104-
Albert Einstein Medical CenterPhiladelphiaPennsylvania19141-
Rhode Island HospitalProvidenceRhode Island02903-
The Miriam HospitalProvidenceRhode Island02903-
Ascension St. Francis HospitalMilwaukeeWisconsin53215-
Ascension All SaintsRacineWisconsin53405-

Find similar trials in Orange, CA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
St. Jude Hospital Yorba Linda dba St. Joseph Heritage Healthcare· Orange, CAAscension St. Vincent's Riverside Hospital· Jacksonville, FLGrady Memorial Hospital· Atlanta, GASt. Vincent Medical Group, Inc· Indianapolis, INSt. Agnes Healthcare· Baltimore, MDBrigham and Women's Hospital· Boston, MA

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