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Trial - NCT04470622


Column Value
Trial registration number NCT04470622
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04470622

First author
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

Neil Clendeninn, PhD, MD

Contact
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

nclendeninn@herontx.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-07-14

Recruitment status
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

Terminated

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

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
Last imported at : March 11, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- 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.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Heron Therapeutics

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Countries
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

27

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Proportion of subjects alive and discharged from the hospital.

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 113, "treatment_name": "Aprepitant", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]