Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
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|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
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Aprepitant injectable emulsion Drug: Saline Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
Drug: Saline Placebo
Saline Placebo, once daily (QD) for 14 days.
- Proportion of Subjects Alive and Discharged From the Hospital. [ Time Frame: 14 Days. ]ITT Population.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|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|
Documents provided by Heron Therapeutics:
|Responsible Party:||Heron Therapeutics|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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