Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

Influenza Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610047
• Other study ID #: NKT-203
• Status: Completed
• Phase: Phase 2
• Start date: December 14, 2020
• Est. completion date: February 9, 2022

Study information

• Verified date: January 2023
• Source: Emergo Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 315
• Est. completion date: February 9, 2022
• Est. primary completion date: January 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza -Like Illness
• Influenza, Human

Intervention

Drug:
• Norketotifen
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
United States	Cedar Health Research	Dallas	Texas
United States	Omega Research Debary	DeBary	Florida
United States	Horizon Research Group of Opelousas	Eunice	Louisiana
United States	Advanced Medical Group	Houston	Texas
United States	Clinical Research Solutions	Jackson	Tennessee
United States	The Chappel Group Research	Kissimmee	Florida
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Downtown LA Research Center	Los Angeles	California
United States	Relief Integrated Health Care	Louisburg	North Carolina
United States	Premier Research Associate	Miami	Florida
United States	Research Institute of South Florida	Miami	Florida
United States	South Florida Research Center	Miami	Florida
United States	Clinical Research Solutions	Middleburg Heights	Ohio
United States	Frontier Clinical Research	Morgantown	West Virginia
United States	Precision Trials AZ	Phoenix	Arizona
United States	Health Concepts	Rapid City	South Dakota
United States	Frontier Clinical Research	Scottdale	Pennsylvania
United States	Frontier Clinical Research	Smithfield	Pennsylvania
United States	Continental Clinical Solutions	Towson	Maryland
United States	Clinovacare Medical Research Center	West Columbia	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Emergo Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to alleviation of symptoms	Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)	14 days
Secondary	Time to resolution of fever (body temperature equal to or less than 37ºC)		14 days
Secondary	Proportion of subjects whose symptoms have been alleviated at each time point through Day 14		14 days
Secondary	Change from baseline in composite symptom score at each time point through Day 14		14 days
Secondary	Body temperature at each time point through Day 14		14 days
Secondary	Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)		14 days
Secondary	Time to resumption of normal activity		14 days
Secondary	Use of rescue medication (acetaminophen)		14 days
Secondary	Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)		14 days
Secondary	Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)		14 days