A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)

Emergo Therapeutics, Inc.17 sites in 1 country238 target enrollmentOctober 21, 2019

ConditionsInfluenza -Like Illness

InterventionsNorketotifen Placebo

DrugsNorketotifen Placebo

Overview

Phase: Phase 2
Intervention: Norketotifen
Conditions: Influenza -Like Illness
Sponsor: Emergo Therapeutics, Inc.
Enrollment: 238
Locations: 17
Primary Endpoint: Time to alleviation of symptoms
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.

Registry

clinicaltrials.gov

Start Date

October 21, 2019

End Date

April 20, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Emergo Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
•Symptoms of ILI including all of the following:
•Fever ≥38º Celsius (oral) in the predose examinations or \>4 hours after dosing of antipyretics if they were taken
•At least one of the following general systemic symptoms associated with ILI are present with a severity of moderate or greater: headache, feverishness or chills, muscle or joint pain, fatigue
•At least one of the following respiratory symptoms associated with ILI are present with a severity of moderate or greater: cough, sore throat, nasal congestion
•The time interval between the onset of symptoms and the predose examinations is ≤96 hours. The onset of symptoms is defined as either:
•Time of the first increase in body temperature (an increase of at least 1º Celsius from normal body temperature)
•Time when the subject experiences at least one general or respiratory symptom
•Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria

•Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
•Severe ILI requiring inpatient treatment
•Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):
•Residents of nursing homes or other long-term care facilities
•American Indians and Alaska natives
•Chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
•Neurological and neurodevelopmental conditions (including disorders of the brain, spinal cord, peripheral nerve, and muscle such as cerebral palsy, epilepsy \[seizure disorders\], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy, or spinal cord injury)
•Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease)
•Blood disorders (such as sickle cell disease)
•Endocrine disorders (such as diabetes mellitus)

Arms & Interventions

Norketotifen

Norketotifen oral capsules, once daily for 5 days

Intervention: Norketotifen

Placebo

Placebo oral capsules, once daily for 5 days

Intervention: Placebo

Outcomes

Primary Outcomes

Time to alleviation of symptoms

Time Frame: 14 days

Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)

Secondary Outcomes

Proportion of subjects whose symptoms have been alleviated at each time point through Day 5(5 days)
Change from baseline in composite symptom score at each time point through Day 5(5 days)
Time to resolution of fever (body temperature equal to or less than 37ºC)(14 days)
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)(14 days)
Time to resumption of normal activity(14 days)
Body temperature at each time point through Day 5(5 days)
Use of rescue medication (acetaminophen)(14 days)