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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04470622
Recruitment Status : Terminated (Study was terminated early by Heron, and was not terminated for safety reasons.)
First Posted : July 14, 2020
Results First Posted : August 30, 2022
Last Update Posted : August 30, 2022
Information provided by (Responsible Party):
Heron Therapeutics

Tracking Information
First Submitted Date  ICMJE July 13, 2020
First Posted Date  ICMJE July 14, 2020
Results First Submitted Date  ICMJE April 8, 2022
Results First Posted Date  ICMJE August 30, 2022
Last Update Posted Date August 30, 2022
Actual Study Start Date  ICMJE July 20, 2020
Actual Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2022)
Proportion of Subjects Alive and Discharged From the Hospital. [ Time Frame: 14 Days. ]
ITT Population.
Original Primary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
Proportion of subjects alive and discharged from the hospital. [ Time Frame: 14 Days. ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2022)
  • 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. [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2020)
  • 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, 56. ]
  • Incidence of treatment-emergent adverse events. [ Time Frame: From signing ICF to Day 56. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Official Title  ICMJE A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Aprepitant injectable emulsion
    Aprepitant injectable emulsion, once daily (QD) for 14 days.
  • Drug: Saline Placebo
    Saline Placebo, once daily (QD) for 14 days.
Study Arms  ICMJE
  • Experimental: Treatment Group 1
    Aprepitant injectable emulsion.
    Intervention: Drug: Aprepitant injectable emulsion
  • Placebo Comparator: Treatment Group 2
    Saline placebo.
    Intervention: Drug: Saline Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 13, 2021)
Original Estimated Enrollment  ICMJE
 (submitted: July 13, 2020)
Actual Study Completion Date  ICMJE June 3, 2021
Actual Primary Completion Date April 9, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
Administrative Information
NCT Number  ICMJE NCT04470622
Other Study ID Numbers  ICMJE HTX-019-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Heron Therapeutics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Heron Therapeutics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heron Therapeutics
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP