Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1) (NCT04470622) | Clinical Trial Compass
TerminatedPhase 2
Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)
Stopped: Study was terminated early by Heron, and was not terminated for safety reasons.
United States27 participantsStarted 2020-07-20
Plain-language summary
The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Proportion of Subjects Alive and Discharged From the Hospital.