Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment Group 1
Aprepitant injectable emulsion.
  • Drug: Aprepitant injectable emulsion
    Aprepitant injectable emulsion, once daily (QD) for 14 days.
Placebo Comparator
Treatment Group 2
Saline placebo.
  • Drug: Saline Placebo
    Saline Placebo, once daily (QD) for 14 days.

Recruiting Locations

Memorial Hermann - Memorial City Medical Center
Houston, Texas 77024

More Details

Status
Recruiting
Sponsor
Heron Therapeutics

Study Contact

Neil Clendeninn, PhD, MD
1-619-772-2641
nclendeninn@herontx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.