A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19

Heron Therapeutics3 sites in 1 country27 target enrollmentJuly 20, 2020

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Aprepitant injectable emulsion
Conditions: COVID-19
Sponsor: Heron Therapeutics
Enrollment: 27
Locations: 3
Primary Endpoint: Proportion of Subjects Alive and Discharged From the Hospital.
Status: Terminated
Last Updated: 3 years ago

The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.

Registry

clinicaltrials.gov

Start Date

July 20, 2020

End Date

June 3, 2021

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Sponsor

•Is hospitalized for ≤48 hours with SARS-CoV-2 infection. Confirmed by polymerase chain reaction (PCR), antigen or immunoglobulin M (IgM) antibody test.
•Has at least 1 of the following: Radiographic infiltrates by imaging, or oxygen saturation of \<94% by pulse oximetry on room air or requiring supplemental oxygen.
•Not anticipated to require mechanical ventilation within 48 hours.

•Is taking high-dose hydroxychloroquine or chloroquine.
•Is taking pimozide or strong or moderate CYP3A4 inhibitors.
•Is currently receiving treatment with products intended to modify immune response to COVID-19 (exception: dexamethasone, methylprednisolone, or equivalent are allowed), chemotherapy or on hemodialysis or peritoneal dialysis.
•Has known hypersensitivity to any components of aprepitant injectable emulsion.
•Has evidence of ARDS.
•Is being treated with oxygen delivered by high-flow nasal cannula nonrebreather mask, noninvasive positive pressure ventilation, or ECMO.
•Has multiple organ failure.
•Has current confirmed Influenza A or B infection, or a a history of organ or hematologic transplant, HIV, or active hepatitis B or hepatitis C infection.

Aprepitant injectable emulsion.

Intervention: Aprepitant injectable emulsion

Saline placebo.

Intervention: Saline Placebo

Proportion of Subjects Alive and Discharged From the Hospital.

Time Frame: 14 Days.

ITT Population.

Incidence of Treatment-emergent Adverse Events.(Through Day 56)
Time to Discharge From Hospital.(56 Days.)
Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO).(56 Days.)
Change From Baseline in Interleukin 6 (IL-6).(Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo)))