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Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

Aprepitant Injectable Emulsion in Patients With COVID-19 (GUARDS-1)

Recruiting
18 years and older
All
Phase 2

Overview

The study will evaluate the efficacy and safety of aprepitant injectable emulsion added to standard of care for hospitalized patients with COVID-19.

Eligibility

Inclusion Criteria:

  • 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.

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 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.

Study details
    Covid 19

NCT04470622

Heron Therapeutics

5 August 2020

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