Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aprepitant injectable emulsion
Saline Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring COVID-19, Coronavirus
Eligibility Criteria
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.
Sites / Locations
- Helen Keller Hospital
- University of California, Irvine Medical Center
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment Group 1
Treatment Group 2
Arm Description
Aprepitant injectable emulsion.
Saline placebo.
Outcomes
Primary Outcome Measures
Proportion of Subjects Alive and Discharged From the Hospital.
ITT Population.
Secondary Outcome Measures
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 to Discharge From Hospital.
Change From Baseline in Interleukin 6 (IL-6).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04470622
Brief Title
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Official Title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated early by Heron, and was not terminated for safety reasons.
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
April 9, 2021 (Actual)
Study Completion Date
June 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heron Therapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19, Coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment Group 1
Arm Type
Experimental
Arm Description
Aprepitant injectable emulsion.
Arm Title
Treatment Group 2
Arm Type
Placebo Comparator
Arm Description
Saline placebo.
Intervention Type
Drug
Intervention Name(s)
Aprepitant injectable emulsion
Intervention Description
Aprepitant injectable emulsion, once daily (QD) for 14 days.
Intervention Type
Drug
Intervention Name(s)
Saline Placebo
Intervention Description
Saline Placebo, once daily (QD) for 14 days.
Primary Outcome Measure Information:
Title
Proportion of Subjects Alive and Discharged From the Hospital.
Description
ITT Population.
Time Frame
14 Days.
Secondary Outcome Measure Information:
Title
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.
Title
Time to Discharge From Hospital.
Time Frame
56 Days.
Title
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))
Title
Incidence of Treatment-emergent Adverse Events.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Helen Keller Hospital
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Facility Name
University of California, Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
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