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

  • STATUS
    Recruiting
  • participants needed
    100
  • sponsor
    Heron Therapeutics
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Updated on 19 February 2024
See if I qualify
mechanical ventilation
PCR test
oximetry
covid-19
SARS
pulse oximetry
acute respiratory syndrome (sars)

Summary

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

Details
Condition Covid 19
Age 18years - 100years
Treatment Saline Placebo, Aprepitant injectable emulsion
Clinical Study IdentifierNCT04470622
SponsorHeron Therapeutics
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
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Entire World

4 study centers available

    Helen Keller Hospital

    Sheffield AL United States

    Yale University School of Medicine

    New Haven CT United States

    Memorial Hermann - Memorial City Medical Center

    Houston TX United States

    Ponce Medical School Foundation

    Puerto Rico

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Helen Keller Hospital

Sheffield AL United States

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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