Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

NCT ID: NCT04610047

Last Updated: 2023-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 315 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-14
• Study Completion Date: 2022-02-09

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.

Conditions

Influenza; Influenza -Like Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Norketotifen

Norketotifen oral capsules, twice daily for 7 days

Group Type: EXPERIMENTAL

Norketotifen

Intervention Type: DRUG

Oral capsule

Placebo

Placebo oral capsules, twice daily for 7 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral capsule

Interventions

Norketotifen

Oral capsule

Intervention Type: DRUG

Placebo

Oral capsule

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emergo Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Precision Trials AZ

Phoenix, Arizona, United States

Downtown LA Research Center

Los Angeles, California, United States

Omega Research Debary

DeBary, Florida, United States

The Chappel Group Research

Kissimmee, Florida, United States

South Florida Research Center

Miami, Florida, United States

Premier Research Associate

Miami, Florida, United States

Research Institute of South Florida

Miami, Florida, United States

Horizon Research Group of Opelousas

Eunice, Louisiana, United States

Continental Clinical Solutions

Towson, Maryland, United States

Clinical Research of South Nevada

Las Vegas, Nevada, United States

Relief Integrated Health Care

Louisburg, North Carolina, United States

Clinical Research Solutions

Middleburg Heights, Ohio, United States

Frontier Clinical Research

Scottdale, Pennsylvania, United States

Frontier Clinical Research

Smithfield, Pennsylvania, United States

Clinovacare Medical Research Center

West Columbia, South Carolina, United States

Health Concepts

Rapid City, South Dakota, United States

Clinical Research Solutions

Jackson, Tennessee, United States

Cedar Health Research

Dallas, Texas, United States

Advanced Medical Group

Houston, Texas, United States

Frontier Clinical Research

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

NKT-203

Identifier Type: -

Identifier Source: org_study_id