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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04470622
• Other study ID #: HTX-019-202
• Status: Terminated
• Phase: Phase 2
• Start date: July 20, 2020
• Est. completion date: June 3, 2021

Study information

• Verified date: August 2022
• Source: Heron Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 3, 2021
• Est. primary completion date: April 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Aprepitant injectable emulsion
Aprepitant injectable emulsion, once daily (QD) for 14 days.
• Saline Placebo
Saline Placebo, once daily (QD) for 14 days.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut
United States	University of California, Irvine Medical Center	Orange	California
United States	Helen Keller Hospital	Sheffield	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Heron Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Subjects Alive and Discharged From the Hospital.	ITT Population.	14 Days.
Secondary	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.
Secondary	Time to Discharge From Hospital.		56 Days.
Secondary	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))
Secondary	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