NCT04470622

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2 covid19

Timeline
Completed

Started Jul 2020

Typical duration for phase_2 covid19

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

July 20, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2021

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 30, 2022

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

9 months

First QC Date

July 13, 2020

Results QC Date

April 8, 2022

Last Update Submit

February 10, 2026

Conditions

COVID-19

Keywords

COVID-19Coronavirus

Outcome Measures

Primary Outcomes (1)

  • Proportion of Subjects Alive and Discharged From the Hospital.

    ITT Population.

    14 Days.

Secondary Outcomes (4)

  • 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.

    Through Day 56

Study Arms (2)

Treatment Group 1

EXPERIMENTAL

Aprepitant injectable emulsion.

Drug: Aprepitant injectable emulsion

Treatment Group 2

PLACEBO COMPARATOR

Saline placebo.

Drug: Saline Placebo

Interventions

Aprepitant injectable emulsionDRUG

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

Treatment Group 1
Saline PlaceboDRUG

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

Treatment Group 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Limitations and Caveats

Study was terminated early by Heron, and was not terminated for safety reasons. The data reported is only safety data generated from the study.

Results Point of Contact

Title
Tricia Mulford
Organization
Heron Therapeutics, Inc.
tmulford@herontx.com
760-622-3709

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

July 14, 2020

Study Start

July 20, 2020

Primary Completion

April 9, 2021

Study Completion

June 3, 2021

Last Updated

March 2, 2026

Results First Posted

August 30, 2022

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(3)