Norketotifen for the Treatment of Uncomplicated Influenza-like Illness
- Registration Number
- NCT04043923
- Lead Sponsor
- Emergo Therapeutics, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 238
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Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
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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
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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
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Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol
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Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
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Severe ILI requiring inpatient treatment
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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)
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Presence of any severe or uncontrolled medical or psychiatric illness
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History of or current autoimmune disease
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History of recurrent lower respiratory tract infection
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Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
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Female subjects who are pregnant or breastfeeding
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Any clinically significant electrocardiogram test
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Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
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Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
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Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
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Exposure to an investigational drug within 30 days prior to the pre-dose examinations
-
History of allergic reaction to ketotifen
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Any prior exposure to norketotifen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo oral capsules, once daily for 5 days Norketotifen Norketotifen Norketotifen oral capsules, once daily for 5 days
- Primary Outcome Measures
Name Time Method Time to alleviation of symptoms 14 days Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
- Secondary Outcome Measures
Name Time Method 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 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 Body temperature at each time point through Day 5 5 days Use of rescue medication (acetaminophen) 14 days Time to resumption of normal activity 14 days
Trial Locations
- Locations (17)
Cahaba Research
🇺🇸Birmingham, Alabama, United States
Precision Trials AZ
🇺🇸Phoenix, Arizona, United States
Long Beach Clinical Trial Services
🇺🇸Long Beach, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Northern California Research
🇺🇸Sacramento, California, United States
AFC Urgent Care
🇺🇸Denver, Colorado, United States
South Florida Research Center
🇺🇸Miami, Florida, United States
Premier Research Associate
🇺🇸Miami, Florida, United States
Gulfcoast Medical Research
🇺🇸Tampa, Florida, United States
DelRicht Research
🇺🇸New Orleans, Louisiana, United States
Scroll for more (7 remaining)Cahaba Research🇺🇸Birmingham, Alabama, United States