The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
Drug: Aprepitant injectable emulsion
Aprepitant injectable emulsion, once daily (QD) for 14 days.
Drug: Saline Placebo
Saline Placebo, once daily (QD) for 14 days.
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.
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