Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Purpose
The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
Condition
- COVID-19
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Treatment Group 1 |
Aprepitant injectable emulsion. |
|
Placebo Comparator Treatment Group 2 |
Saline placebo. |
|
Recruiting Locations
More Details
- NCT ID
- NCT04470622
- Status
- Terminated
- Sponsor
- Heron Therapeutics