Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
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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 : March 9, 2021
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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) |
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 : | June 2021 |
Estimated Study Completion Date : | July 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Treatment Group 1
Aprepitant injectable emulsion.
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Drug: Aprepitant injectable emulsion
Aprepitant injectable emulsion, once daily (QD) for 14 days. |
Placebo Comparator: Treatment Group 2
Saline placebo.
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Drug: Saline Placebo
Saline Placebo, once daily (QD) for 14 days. |
- Proportion of subjects alive and discharged from the hospital. [ Time Frame: 14 Days. ]
- 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. ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Neil Clendeninn, PhD, MD | 1-619-772-2641 | nclendeninn@herontx.com |
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 |
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: | March 9, 2021 |
Last Verified: | March 2021 |
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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