Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

Phase 2

Completed

• Conditions: Influenza; Influenza -Like Illness
• Interventions: Drug: Norketotifen; Drug: Placebo

• Registration Number: NCT04610047
• 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

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Study Start: 2020-12-14
• Primary Completion: 2022-01-25
• Study Completion: 2022-02-09
• Status Verified: 2023-01
• Disposition First Submitted: 2023-01-25
• Disposition First Submitted QC: 2023-01-25
• Last Update Submitted: 2023-01-25
• Disposition First Posted: 2023-01-30
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 315

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Norketotifen	Norketotifen	Norketotifen oral capsules, twice daily for 7 days
Placebo	Placebo	Placebo oral capsules, twice daily for 7 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 by confirmed viral pathogen (influenza vs non influenza)	14 days
Time to resolution of fever (body temperature equal to or less than 37ºC)	14 days
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14	14 days
Change from baseline in composite symptom score at each time point through Day 14	14 days
Body temperature at each time point through Day 14	14 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)	14 days
Time to resumption of normal activity	14 days
Use of rescue medication (acetaminophen)	14 days
Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)	14 days

Trial Locations

Locations (17)

Clinovacare Medical Research Center; 🇺🇸 West Columbia, South Carolina, United States

Horizon Research Group of Opelousas; 🇺🇸 Eunice, Louisiana, United States

Continental Clinical Solutions; 🇺🇸 Towson, Maryland, United States

Relief Integrated Health Care; 🇺🇸 Louisburg, North Carolina, United States

Omega Research Debary; 🇺🇸 DeBary, Florida, United States

Clinical Research Solutions; 🇺🇸 Jackson, Tennessee, United States

Health Concepts; 🇺🇸 Rapid City, South Dakota, United States

The Chappel Group Research; 🇺🇸 Kissimmee, Florida, United States

South Florida Research Center; 🇺🇸 Miami, Florida, United States

Research Institute of South Florida; 🇺🇸 Miami, Florida, United States

Advanced Medical Group; 🇺🇸 Houston, Texas, United States

Precision Trials AZ; 🇺🇸 Phoenix, Arizona, United States

Downtown LA Research Center; 🇺🇸 Los Angeles, California, United States

Premier Research Associate; 🇺🇸 Miami, Florida, United States

Cedar Health Research; 🇺🇸 Dallas, Texas, United States

Clinical Research of South Nevada; 🇺🇸 Las Vegas, Nevada, United States

Frontier Clinical Research; 🇺🇸 Morgantown, West Virginia, United States