Status:
TERMINATED
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Lead Sponsor:
Heron Therapeutics
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 3 2021
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04470622
Start Date
July 20 2020
End Date
June 3 2021
Last Update
August 30 2022
Active Locations (3)
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1
Helen Keller Hospital
Sheffield, Alabama, United States, 35660
2
University of California, Irvine Medical Center
Orange, California, United States, 92868
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510