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

• ClinicalTrials.gov Identifier: NCT04470622
• Recruitment Status: Terminated
• First Posted: July 14, 2020
• Results First Posted: August 30, 2022
• Last Update Posted: August 30, 2022
• Sponsor: Heron Therapeutics
• Information provided by (Responsible Party): Heron Therapeutics

Tracking Information

• First Submitted Date: July 13, 2020
• First Posted Date: July 14, 2020
• Results First Submitted Date: April 8, 2022
• Results First Posted Date: August 30, 2022
• Last Update Posted Date: August 30, 2022
• Actual Study Start Date: July 20, 2020
• Actual Primary Completion Date: April 9, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 8, 2022)

Proportion of Subjects Alive and Discharged From the Hospital. [ Time Frame: 14 Days. ]

ITT Population.

• Original Primary Outcome Measures (submitted: July 13, 2020): Proportion of subjects alive and discharged from the hospital. [ Time Frame: 14 Days. ]

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: COVID-19

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: October 13, 2021): 27
• Original Estimated Enrollment (submitted: July 13, 2020): 100
• Actual Study Completion Date: June 3, 2021
• Actual Primary Completion Date: April 9, 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States
• Removed Location Countries: Puerto Rico

Administrative Information

• NCT Number: NCT04470622
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Heron Therapeutics
• Original Responsible Party: Same as current
• Current Study Sponsor: Heron Therapeutics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Heron Therapeutics
• Verification Date: August 2022