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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID-19

In brief

The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.

Key facts

Study ID

NCT04470622

Run by

Heron Therapeutics

People needed

27

Starts

2020-07-20

Expected to finish

2021-06-03

Last updated by the study team

2026-03-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Helen Keller Hospital — Sheffield, Alabama, United States
• University of California, Irvine Medical Center — Orange, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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