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Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

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ClinicalTrials.gov Identifier: NCT04610047
Recruitment Status : Recruiting
First Posted : October 30, 2020
Last Update Posted : August 18, 2021
Sponsor:
Information provided by (Responsible Party):
Emergo Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE October 26, 2020
First Posted Date  ICMJE October 30, 2020
Last Update Posted Date August 18, 2021
Actual Study Start Date  ICMJE December 14, 2020
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
Time to alleviation of symptoms [ Time Frame: 14 days ]
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2020)
  • Time to resolution of fever (body temperature equal to or less than 37ºC) [ Time Frame: 14 days ]
  • Proportion of subjects whose symptoms have been alleviated at each time point through Day 14 [ Time Frame: 14 days ]
  • Change from baseline in composite symptom score at each time point through Day 14 [ Time Frame: 14 days ]
  • Body temperature at each time point through Day 14 [ Time Frame: 14 days ]
  • Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion) [ Time Frame: 14 days ]
  • Time to resumption of normal activity [ Time Frame: 14 days ]
  • Use of rescue medication (acetaminophen) [ Time Frame: 14 days ]
  • Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza) [ Time Frame: 14 days ]
  • Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza) [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness
Official Title  ICMJE 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)
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Influenza
  • Influenza -Like Illness
Intervention  ICMJE
  • Drug: Norketotifen
    Oral capsule
  • Drug: Placebo
    Oral capsule
Study Arms  ICMJE
  • Experimental: Norketotifen
    Norketotifen oral capsules, twice daily for 7 days
    Intervention: Drug: Norketotifen
  • Placebo Comparator: Placebo
    Placebo oral capsules, twice daily for 7 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2020)
320
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 15, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Emergo Therapeutics Clinical Trials 984-377-5151 ext 204 ClinicalTrial@emergotherapeutics.com
Listed Location Countries  ICMJE Australia,   New Zealand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04610047
Other Study ID Numbers  ICMJE NKT-203
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Emergo Therapeutics, Inc.
Study Sponsor  ICMJE Emergo Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Emergo Therapeutics, Inc.
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP