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

H

Heron Therapeutics

Status and phase

Terminated
Phase 2

Conditions

COVID-19

Treatments

Drug: Aprepitant injectable emulsion
Drug: Saline Placebo

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

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

Trial documents
2

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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