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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04610047
Other study ID # NKT-203
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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