Norketotifen for the Treatment of Uncomplicated Influenza-like Illness

Influenza -Like Illness 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: NCT04043923
• Other study ID #: NKT-202
• Status: Completed
• Phase: Phase 2
• Start date: October 21, 2019
• Est. completion date: April 20, 2020

Study information

• Verified date: March 2021
• 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: 238
• Est. completion date: April 20, 2020
• Est. primary completion date: April 5, 2020
• 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) in the predose examinations or >4 hours after dosing of antipyretics if they were taken
• 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. The time interval between the onset of symptoms and the predose examinations is =96

hours. The onset of symptoms is defined as either:

• Time of the first increase in body temperature (an increase of at least 1º Celsius from normal body temperature)
• Time when the subject experiences at least one general or respiratory symptom

4. Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

Exclusion Criteria:

1. Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding

2. Severe ILI requiring inpatient treatment

3. Any of the following risk factors (according to the CDC's list of People at High Risk

for Developing Serious Flu-Related Complications):

• 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)
• Extreme obesity (body mass index =40 kg/m^2)

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

5. History of or current autoimmune disease

6. History of recurrent lower respiratory tract infection

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

8. Female subjects who are pregnant or breastfeeding

9. Any clinically significant electrocardiogram test

10. Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations

11. Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations

12. Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations

13. Exposure to an investigational drug within 30 days prior to the pre-dose examinations

14. History of allergic reaction to ketotifen

15. Any prior exposure to norketotifen

Related Conditions & MeSH terms

• Influenza -Like Illness
• Influenza, Human

Intervention

Drug:
• Norketotifen
Oral capsule
• Placebo
Oral capsule

Locations

Country	Name	City	State
United States	Premier Family Physicians	Austin	Texas
United States	DelRicht Research	Baton Rouge	Louisiana
United States	Cahaba Research	Birmingham	Alabama
United States	Family Medicine Associates of Texas	Carrollton	Texas
United States	OnSite Clinical Solutions	Charlotte	North Carolina
United States	CityDoc Urgent Care	Dallas	Texas
United States	AFC Urgent Care	Denver	Colorado
United States	Long Beach Clinical Trial Services	Long Beach	California
United States	Premier Research Associate	Miami	Florida
United States	South Florida Research Center	Miami	Florida
United States	DelRicht Research	New Orleans	Louisiana
United States	Precision Trials AZ	Phoenix	Arizona
United States	Village Health Partners	Plano	Texas
United States	Empire Clinical Research	Pomona	California
United States	Health Concepts	Rapid City	South Dakota
United States	Northern California Research	Sacramento	California
United States	The Clinical Research Center	Saint Louis	Missouri
United States	Gulfcoast Medical Research	Tampa	Florida

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	Proportion of subjects whose symptoms have been alleviated at each time point through Day 5		5 days
Secondary	Change from baseline in composite symptom score at each time point through Day 5		5 days
Secondary	Time to resolution of fever (body temperature equal to or less than 37ºC)		14 days
Secondary	Body temperature at each time point through Day 5		5 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