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Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

Sponsor
Emergo Therapeutics, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04610047
Collaborator
(none)
315
Enrollment
20
Locations
2
Arms
13.9
Actual Duration (Months)
15.8
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Dec 14, 2020
Actual Primary Completion Date :
Jan 25, 2022
Actual Study Completion Date :
Feb 9, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. 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

  1. Time to resolution of fever (body temperature equal to or less than 37ºC) [14 days]

  2. Proportion of subjects whose symptoms have been alleviated at each time point through Day 14 [14 days]

  3. Change from baseline in composite symptom score at each time point through Day 14 [14 days]

  4. Body temperature at each time point through Day 14 [14 days]

  5. Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion) [14 days]

  6. Time to resumption of normal activity [14 days]

  7. Use of rescue medication (acetaminophen) [14 days]

  8. Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza) [14 days]

  9. Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza) [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. Total symptom severity score (sum of the scores of all 7 individual symptoms) of ≥11 in the predose examinations

  2. The time interval between the onset of symptoms and the predose examinations is ≤48 hours.

  3. 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)

  1. Presence of any severe or uncontrolled medical or psychiatric illness

  2. History of or current autoimmune disease

  3. History of recurrent lower respiratory tract infection

  4. Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy

  5. Any clinically significant electrocardiogram (ECG) test

  6. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the predose examinations

  7. Received an investigational monoclonal antibody for a viral disease in the last year prior to the predose examinations

  8. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the predose examinations

  9. Exposure to an investigational drug within 30 days prior to the predose examinations

  10. History of allergic reaction to ketotifen

  11. Any prior exposure to norketotifen

Contacts and Locations

Locations

Site City State Country Postal Code
1 Precision Trials AZ Phoenix Arizona United States 85032
2 Downtown LA Research Center Los Angeles California United States 90017
3 Omega Research Debary DeBary Florida United States 32713
4 The Chappel Group Research Kissimmee Florida United States 34744
5 South Florida Research Center Miami Florida United States 33135
6 Premier Research Associate Miami Florida United States 33165
7 Research Institute of South Florida Miami Florida United States 33173
8 Horizon Research Group of Opelousas Eunice Louisiana United States 70535
9 Continental Clinical Solutions Towson Maryland United States 21204
10 Clinical Research of South Nevada Las Vegas Nevada United States 89121
11 Relief Integrated Health Care Louisburg North Carolina United States 27549
12 Clinical Research Solutions Middleburg Heights Ohio United States 44130
13 Frontier Clinical Research Scottdale Pennsylvania United States 15683
14 Frontier Clinical Research Smithfield Pennsylvania United States 15478
15 Clinovacare Medical Research Center West Columbia South Carolina United States 29169
16 Health Concepts Rapid City South Dakota United States 57702
17 Clinical Research Solutions Jackson Tennessee United States 38305
18 Cedar Health Research Dallas Texas United States 75251
19 Advanced Medical Group Houston Texas United States 77027
20 Frontier Clinical Research Morgantown West Virginia United States 26505

Sponsors and Collaborators

  • Emergo Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Emergo Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT04610047
Other Study ID Numbers:
  • NKT-203
First Posted:
Oct 30, 2020
Last Update Posted:
Apr 20, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Influenza, Human

Study Results

No Results Posted as of Apr 20, 2022