Status:
COMPLETED
Norketotifen for the Treatment of Uncomplicated Influenza-like Illness
Lead Sponsor:
Emergo Therapeutics, Inc.
Conditions:
Influenza -Like Illness
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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 in...
Eligibility Criteria
Inclusion
- 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
- 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)
- Extreme obesity (body mass index ≥40 kg/m\^2)
- Presence of any severe or uncontrolled medical or psychiatric illness
- History of or current autoimmune disease
- History of recurrent lower respiratory tract infection
- Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
- Female subjects who are pregnant or breastfeeding
- Any clinically significant electrocardiogram test
- Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
- Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
- Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
- Exposure to an investigational drug within 30 days prior to the pre-dose examinations
- History of allergic reaction to ketotifen
- Any prior exposure to norketotifen
Key Trial Info
Start Date :
October 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2020
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT04043923
Start Date
October 21 2019
End Date
April 20 2020
Last Update
March 24 2021
Active Locations (18)
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1
Cahaba Research
Birmingham, Alabama, United States, 35235
2
Precision Trials AZ
Phoenix, Arizona, United States, 85032
3
Long Beach Clinical Trial Services
Long Beach, California, United States, 90806
4
Empire Clinical Research
Pomona, California, United States, 91767