Clinical trial NCT04043923: Norketotifen for the Treatment of Uncomplicated Influenza-like Illness
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza -Like Illness
Lead sponsor: Emergo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-02
Enrollment: 238
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
2. 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
3. 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
4. Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria:

1. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
2. Severe ILI requiring inpatient treatment
3. 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)
   * Extreme obesity (body mass index ≥40 kg/m\^2)
4. Presence of any severe or uncontrolled medical or psychiatric illness
5. History of or current autoimmune disease
6. History of recurrent lower respiratory tract infection
7. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
8. Female subjects who are pregnant or breastfeeding
9. Any clinically significant electrocardiogram test
10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
13. Exposure to an investigational drug within 30 days prior to the pre-dose examinations
14. History of allergic reaction to ketotifen
15. Any prior exposure to norketotifen

Primary outcomes:
measure: Time to alleviation of symptoms
timeFrame: 14 days
Secondary outcomes:
measure: Proportion of subjects whose symptoms have been alleviated at each time point through Day 5
timeFrame: 5 days
measure: Change from baseline in composite symptom score at each time point through Day 5
timeFrame: 5 days
measure: Time to resolution of fever (body temperature equal to or less than 37ºC)
timeFrame: 14 days
measure: Body temperature at each time point through Day 5
timeFrame: 5 days
measure: Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
timeFrame: 14 days
measure: Time to resumption of normal activity
timeFrame: 14 days
measure: Use of rescue medication (acetaminophen)
timeFrame: 14 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research
state: Alabama
city: Phoenix
country: United States
facility: Precision Trials AZ
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Clinical Trial Services
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Sacramento
country: United States
facility: Northern California Research
state: California
city: Denver
country: United States
facility: AFC Urgent Care
state: Colorado
city: Miami
country: United States
facility: South Florida Research Center
state: Florida
city: Miami
country: United States
facility: Premier Research Associate
state: Florida
city: Tampa
country: United States
facility: Gulfcoast Medical Research
state: Florida
city: Baton Rouge
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: Saint Louis
country: United States
facility: The Clinical Research Center
state: Missouri
city: Charlotte
country: United States
facility: OnSite Clinical Solutions
state: North Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Austin
country: United States
facility: Premier Family Physicians
state: Texas
city: Carrollton
country: United States
facility: Family Medicine Associates of Texas
state: Texas
city: Dallas
country: United States
facility: CityDoc Urgent Care
state: Texas
city: Plano
country: United States
facility: Village Health Partners
state: Texas
Study officials:
References: