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

Heron Therapeutics

Status and phase: Terminated; Phase 2

Conditions: COVID-19

Treatments: Drug: Saline Placebo; Drug: Aprepitant injectable emulsion

Study type: Interventional

Funder types: Industry

Identifiers

NCT04470622

HTX-019-202

Details and patient eligibility

About

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

Enrollment: 27 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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27 participants in 2 patient groups, including a placebo group

Treatment Group 1

Experimental group

Description:

Aprepitant injectable emulsion.

Treatment:

Drug: Aprepitant injectable emulsion

Treatment Group 2

Placebo Comparator group

Description:

Saline placebo.

Treatment:

Drug: Saline Placebo