Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

Phase 2TerminatedNCT04470622

Heron Therapeutics27 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COVID-19

Interventions

Aprepitant injectable emulsionDRUG

Aprepitant injectable emulsion, once daily (QD) for 14 days.

Saline PlaceboDRUG

Saline Placebo, once daily (QD) for 14 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (3)

Helen Keller Hospital

Sheffield, Alabama, United States

University of California, Irvine Medical Center

Orange, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Proportion of Subjects Alive and Discharged From the Hospital.

ITT Population.

Time frame: 14 Days.

Secondary Outcomes

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).

Time frame: 56 Days.

Time to Discharge From Hospital.

Time frame: 56 Days.

Change From Baseline in Interleukin 6 (IL-6).

Time frame: Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo))

Incidence of Treatment-emergent Adverse Events.

Number of subjects reporting at least on Treatment-Emergent Adverse Event. Subjects reporting more than one event are counted only once using the highest severity.

Time frame: Through Day 56

Data from ClinicalTrials.gov

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