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

• Status: Terminated
• Trial end date: 2021-06-03
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heron Therapeutics
• Treatments: Aprepitant

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.