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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-06-03

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.

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Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Treatment Group 1

Aprepitant injectable emulsion.

Group Type EXPERIMENTAL

Aprepitant injectable emulsion

Intervention Type DRUG

Aprepitant injectable emulsion, once daily (QD) for 14 days.

Treatment Group 2

Saline placebo.

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type DRUG

Saline Placebo, once daily (QD) for 14 days.

Interventions

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Aprepitant injectable emulsion

Aprepitant injectable emulsion, once daily (QD) for 14 days.

Intervention Type DRUG

Saline Placebo

Saline Placebo, once daily (QD) for 14 days.

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No