Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Is hospitalized for ≤24 hours with SARS-CoV-2 infection. confirmed by polymerase chain reaction test. - Has oxygen saturation ≤93% by pulse oximetry on room air and requiring supplemental. oxygen but 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 resp)onse 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Treatment Group 1
|Aprepitant injectable emulsion.||
Treatment Group 2
- Heron Therapeutics
Study ContactNeil Clendeninn, PhD, MD