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Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04610047
Recruitment Status : Completed
First Posted : October 30, 2020
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Emergo Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Influenza Influenza -Like Illness Drug: Norketotifen Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 14, 2020
Actual Primary Completion Date : January 25, 2022
Actual Study Completion Date : February 9, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arms and Interventions
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Arm Intervention/treatment
Experimental: Norketotifen
Norketotifen oral capsules, twice daily for 7 days
 Drug: Norketotifen
Oral capsule
Placebo Comparator: Placebo
Placebo oral capsules, twice daily for 7 days
 Drug: Placebo
Oral capsule


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Time to resolution of fever (body temperature equal to or less than 37ºC) [ Time Frame: 14 days ]
  2. Proportion of subjects whose symptoms have been alleviated at each time point through Day 14 [ Time Frame: 14 days ]
  3. Change from baseline in composite symptom score at each time point through Day 14 [ Time Frame: 14 days ]
  4. Body temperature at each time point through Day 14 [ Time Frame: 14 days ]
  5. Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion) [ Time Frame: 14 days ]
  6. Time to resumption of normal activity [ Time Frame: 14 days ]
  7. Use of rescue medication (acetaminophen) [ Time Frame: 14 days ]
  8. Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza) [ Time Frame: 14 days ]
  9. Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza) [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610047


Locations
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Sponsors and Collaborators
Emergo Therapeutics, Inc.
More Information
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Responsible Party: Emergo Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04610047    
Other Study ID Numbers: NKT-203
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: January 30, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Influenza, Human
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
 RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases