Clinical trial NCT04610047: Efficacy and Safety of Norketotifen in 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
Influenza -Like Illness
Lead sponsor: Emergo Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-30
Enrollment: 315
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)
   * 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. Total symptom severity score (sum of the scores of all 7 individual symptoms) of ≥11 in the predose examinations
4. The time interval between the onset of symptoms and the predose examinations is ≤48 hours.
5. Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria:

1. Known or suspected infection with Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) or Coronavirus Disease 2019 (COVID-19) illness
2. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
3. Severe ILI requiring inpatient treatment
4. Any of the following risk factors (according to the CDC's list of People at High Risk for Developing Serious Flu-Related Complications):

   * Extreme obesity (body mass index ≥40 kg/m\^2)
   * 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)
5. Presence of any severe or uncontrolled medical or psychiatric illness
6. History of or current autoimmune disease
7. History of recurrent lower respiratory tract infection
8. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
9. Any clinically significant electrocardiogram (ECG) test
10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the predose examinations
11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the predose examinations
12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the predose examinations
13. Exposure to an investigational drug within 30 days prior to the predose 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: Time to resolution of fever (body temperature equal to or less than 37ºC)
timeFrame: 14 days
measure: Proportion of subjects whose symptoms have been alleviated at each time point through Day 14
timeFrame: 14 days
measure: Change from baseline in composite symptom score at each time point through Day 14
timeFrame: 14 days
measure: Body temperature at each time point through Day 14
timeFrame: 14 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
measure: Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)
timeFrame: 14 days
measure: Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)
timeFrame: 14 days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Precision Trials AZ
state: Arizona
city: Los Angeles
country: United States
facility: Downtown LA Research Center
state: California
city: DeBary
country: United States
facility: Omega Research Debary
state: Florida
city: Kissimmee
country: United States
facility: The Chappel Group Research
state: Florida
city: Miami
country: United States
facility: South Florida Research Center
state: Florida
city: Miami
country: United States
facility: Premier Research Associate
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Eunice
country: United States
facility: Horizon Research Group of Opelousas
state: Louisiana
city: Towson
country: United States
facility: Continental Clinical Solutions
state: Maryland
city: Las Vegas
country: United States
facility: Clinical Research of South Nevada
state: Nevada
city: Louisburg
country: United States
facility: Relief Integrated Health Care
state: North Carolina
city: Middleburg Heights
country: United States
facility: Clinical Research Solutions
state: Ohio
city: Scottdale
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research
state: Pennsylvania
city: West Columbia
country: United States
facility: Clinovacare Medical Research Center
state: South Carolina
city: Rapid City
country: United States
facility: Health Concepts
state: South Dakota
city: Jackson
country: United States
facility: Clinical Research Solutions
state: Tennessee
city: Dallas
country: United States
facility: Cedar Health Research
state: Texas
city: Houston
country: United States
facility: Advanced Medical Group
state: Texas
city: Morgantown
country: United States
facility: Frontier Clinical Research
state: West Virginia
Study officials:
References: