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

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

Official Title
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of Aprepitant Injectable Emulsion in Early Hospitalized Adult Patients With COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Aprepitant injectable emulsion
* Drug: Saline Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group 1<br>Aprepitant injectable emulsion. | Drug: Aprepitant injectable emulsion<br>* Aprepitant injectable emulsion, once daily (QD) for 14 days.<br>|
| Placebo Comparator: Treatment Group 2<br>Saline placebo. | Drug: Saline Placebo<br>* Saline Placebo, once daily (QD) for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Alive and Discharged From the Hospital. | ITT Population. | 14 Days. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death or Respiratory Failure, Defined as Any of the Following: Endotracheal Intubation and Mechanical Ventilation; Oxygen Delivered by High-flow Nasal Cannula; Noninvasive Positive Pressure Ventilation; Extracorporeal Membrane Oxygenation (ECMO). |  | 56 Days. | 
| Time to Discharge From Hospital. |  | 56 Days. | 
| Change From Baseline in Interleukin 6 (IL-6). |  | Days 7, 14, 28, Discharge (from 2 to 43 days; median 6 days (Aprepitant), 8 days (Placebo)) | 
| Incidence of Treatment-emergent Adverse Events. | Number of subjects reporting at least on Treatment-Emergent Adverse Event. Subjects reporting more than one event are counted only once using the highest severity. | Through Day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, Coronavirus