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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04470622
Recruitment Status : Recruiting
First Posted : July 14, 2020
Last Update Posted : November 12, 2020
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)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : March 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. ]

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, 56. ]
  4. Incidence of treatment-emergent adverse events. [ Time Frame: From signing ICF to Day 56. ]

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 ≤24 hours with SARS-CoV-2 infection. confirmed by polymerase chain reaction test.
  • Has oxygen saturation ≤93% by pulse oximetry on room air and requiring supplemental. oxygen but 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 resp)onse 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


Contacts
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Contact: Neil Clendeninn, PhD, MD 1-619-772-2641 nclendeninn@herontx.com

Locations
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United States, Alabama
Helen Keller Hospital Recruiting
Sheffield, Alabama, United States, 35660
United States, California
University of California, Irvine Medical Center Recruiting
Orange, California, United States, 92868
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
United States, New York
Stony Brook University Hospital Recruiting
Stony Brook, New York, United States, 11794
United States, Texas
Memorial Hermann - Memorial City Medical Center Recruiting
Houston, Texas, United States, 77024
Puerto Rico
Ponce Medical School Foundation Recruiting
Ponce, Puerto Rico, 00731
Sponsors and Collaborators
Heron Therapeutics
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
Last Update Posted: November 12, 2020
Last Verified: November 2020
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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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