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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
Sponsor:
Information provided by (Responsible Party):
Heron Therapeutics

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Aprepitant injectable emulsion Drug: Saline Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19
Actual Study Start Date : July 20, 2020
Actual Primary Completion Date : April 9, 2021
Actual Study Completion Date : June 3, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aprepitant

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group 1
Aprepitant injectable emulsion.
 Drug: Aprepitant injectable emulsion
Aprepitant injectable emulsion, once daily (QD) for 14 days.
Placebo Comparator: Treatment Group 2
Saline placebo.
 Drug: Saline Placebo
Saline Placebo, once daily (QD) for 14 days.


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of Subjects Alive and Discharged From the Hospital. [ Time Frame: 14 Days. ]
    ITT Population.


Secondary Outcome Measures :
  1. 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. ]
  2. Time to Discharge From Hospital. [ Time Frame: 56 Days. ]
  3. 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)) ]
  4. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04470622


Locations
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United States, Alabama
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
United States, California
University of California, Irvine Medical Center
Orange, California, United States, 92868
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Heron Therapeutics
  Study Documents (Full-Text)

Documents provided by Heron Therapeutics:
Study Protocol  [PDF] December 11, 2020
Statistical Analysis Plan  [PDF] June 22, 2021

More Information
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Responsible Party: Heron Therapeutics
ClinicalTrials.gov Identifier: NCT04470622    
Other Study ID Numbers: HTX-019-202
First Posted: July 14, 2020    Key Record Dates
Results First Posted: August 30, 2022
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heron Therapeutics:
COVID-19
Coronavirus
Additional relevant MeSH terms:
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COVID-19
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action