Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness

Completed · Phase 2 · Has a placebo group

Conditions studied: Influenza, Influenza -Like Illness

In brief

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.

Key facts

Study ID

NCT04610047

Run by

Emergo Therapeutics, Inc.

People needed

315

Starts

2020-12-14

Expected to finish

2022-02-09

Last updated by the study team

2023-01-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand the study and comply with all study procedures, and willing to provide written informed consent prior to the pre-dose examinations
• 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
• Total symptom severity score (sum of the scores of all 7 individual symptoms) of ≥11 in the predose examinations
• The time interval between the onset of symptoms and the predose examinations is ≤48 hours.
• Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol

You may not qualify if…

• Known or suspected infection with Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV2) or Coronavirus Disease 2019 (COVID-19) illness
• Female subjects who are pregnant, 2 weeks post-partum, or breastfeeding
• Severe ILI requiring inpatient treatment
• 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)
• Presence of any severe or uncontrolled medical or psychiatric illness
• History of or current autoimmune disease
• History of recurrent lower respiratory tract infection
• Any concurrent infection requiring systemic antimicrobial and/or antiviral therapy
• Any clinically significant electrocardiogram (ECG) test
• Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the predose examinations
• Received an investigational monoclonal antibody for a viral disease in the last year prior to the predose examinations
• Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the predose examinations

Where it is running

• 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

Full record on ClinicalTrials.gov

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