Norketotifen for the Treatment of Uncomplicated Influenza-like Illness

NCT04043923 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: NKT-202
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 18

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.

Conditions

Influenza -Like Illness

Outcome Measures

Primary Outcomes (1)

• Time to alleviation of symptoms

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

  14 days

Secondary Outcomes (7)

• 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

• Body temperature at each time point through Day 5

  5 days

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

  14 days

Study Arms (2)

Norketotifen

EXPERIMENTAL

Norketotifen oral capsules, once daily for 5 days

Drug: Norketotifen

Placebo

PLACEBO COMPARATOR

Placebo oral capsules, once daily for 5 days

Drug: Placebo

Interventions

Norketotifen DRUG

Oral capsule

Norketotifen

Placebo DRUG

Oral capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Asthma
• 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)
• Kidney disorders
• Liver disorders
• Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
• Compromised immune system due to disease or medication (such as subjects with human immunodeficiency virus or cancer, or those on chronic steroids)

Sponsors & Collaborators

• Emergo Therapeutics, Inc.: lead

Study Sites (18)

Cahaba Research

Birmingham, Alabama, 35235, United States

Location

Precision Trials AZ

Phoenix, Arizona, 85032, United States

Location

Long Beach Clinical Trial Services

Long Beach, California, 90806, United States

Location

Empire Clinical Research

Pomona, California, 91767, United States

Location

Northern California Research

Sacramento, California, 95821, United States

Location

AFC Urgent Care

Denver, Colorado, 80246, United States

Location

South Florida Research Center

Miami, Florida, 33135, United States

Location

Premier Research Associate

Miami, Florida, 33165, United States

Location

Gulfcoast Medical Research

Tampa, Florida, 33607, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70809, United States

Location

DelRicht Research

New Orleans, Louisiana, 70124, United States

Location

The Clinical Research Center

St Louis, Missouri, 63141, United States

Location

OnSite Clinical Solutions

Charlotte, North Carolina, 28277, United States

Location

Health Concepts

Rapid City, South Dakota, 57702, United States

Location

Premier Family Physicians

Austin, Texas, 78735, United States

Location

Family Medicine Associates of Texas

Carrollton, Texas, 75010, United States

Location

CityDoc Urgent Care

Dallas, Texas, 75204, United States

Location

Village Health Partners

Plano, Texas, 75024, United States

Location

MeSH Terms

Interventions

norketotifen

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 2, 2019
• Study Start: October 21, 2019
• Primary Completion: April 5, 2020
• Study Completion: April 20, 2020
• Last Updated: March 24, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)