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	18-100 years
Treatment	Saline Placebo, Aprepitant injectable emulsion
Clinical Study Identifier	NCT04470622
Sponsor	Heron Therapeutics
Last Modified on	19 February 2024

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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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Study Definition

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