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

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Drug: Aprepitant injectable emulsion; Drug: Saline Placebo

• Registration Number: NCT04470622
• Lead Sponsor: Heron Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Study First Posted: 2020-07-14
• Study Start: 2020-07-20
• Primary Completion: 2021-04-09
• Study Completion: 2021-06-03
• Results First Submitted: 2022-04-08
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Results First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Group 1	Aprepitant injectable emulsion	Aprepitant injectable emulsion.
Treatment Group 2	Saline Placebo	Saline placebo.

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Alive and Discharged From the Hospital.	14 Days.	ITT Population.

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-emergent Adverse Events.	Through Day 56	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 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))

Trial Locations

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