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

Phase 2 Terminated 200 enrolled CTI BioPharma

RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start: 2020-05-22
Primary completion: 2021-09-21
Completion: 2021-09-21

Outcome

Missed primary endpoint

Stopped (Enrollment): “decision to close enrollment early”

paper CONCLUSIONS AND RELEVANCE: The study did not meet its primary end point in patients with severe COVID-19. PMID 36469321 ↗

registry analysis (superiority test); Pacritinib and SOC vs Placebo and SOC; p = 0.8516; Risk Difference (RD) 1.51 (95% CI -10.55 to 13.53); Cochran-Mantel-Haenszel NCT04404361 ↗

Publications

Cafardi J, Miller C, Terebelo H, Tewell C, Benzaquen S, Park D, Egan P, Lebovic D, Pettit K, Whitman E, Tremblay D, Feld J, Buckley S, Roman-Torres K, Smith J, Craig A, Mascarenhas J. Efficacy and Safety of Pacritinib vs Placebo for Patients With Severe COVID-19: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2242918. doi: 10.1001/jamanetworkopen.2022.42918.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pacritinib	Small molecule	200 mg	Oral