InfluenzaPhase 2NCT04610047
Efficacy and Safety of Norketotifen in Uncomplicated Influenza-like Illness
A Phase 2 study testing Norketotifen in people with Influenza and Influenza -Like Illness, run by Emergo Therapeutics, Inc. at 20 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Influenza, Influenza -Like Illness
- What is being tested?
- Norketotifen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- 20 sitesUnited States
- Study dates
- 14 Dec 2020to 9 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
- Exposure to an investigational drug within 30 days prior to the predose examinations
- History of allergic reaction to ketotifen
- Any prior exposure to norketotifen
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Cedar Health Research
Dallas, Texas, 75251
Omega Research Debary
DeBary, Florida, 32713
Horizon Research Group of Opelousas
Eunice, Louisiana, 70535
Advanced Medical Group
Houston, Texas, 77027
Clinical Research Solutions
Jackson, Tennessee, 38305
The Chappel Group Research
Kissimmee, Florida, 34744
Clinical Research of South Nevada
Las Vegas, Nevada, 89121
Downtown LA Research Center
Los Angeles, California, 90017
Relief Integrated Health Care
Louisburg, North Carolina, 27549
South Florida Research Center
Miami, Florida, 33135
Premier Research Associate
Miami, Florida, 33165
Research Institute of South Florida
Miami, Florida, 33173
Clinical Research Solutions
Middleburg Heights, Ohio, 44130
Frontier Clinical Research
Morgantown, West Virginia, 26505
Precision Trials AZ
Phoenix, Arizona, 85032
Health Concepts
Rapid City, South Dakota, 57702
Frontier Clinical Research
Scottdale, Pennsylvania, 15683
Frontier Clinical Research
Smithfield, Pennsylvania, 15478
Continental Clinical Solutions
Towson, Maryland, 21204
Clinovacare Medical Research Center
West Columbia, South Carolina, 29169
About this study
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)
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
- Being tested
- Norketotifen, Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorketotifenDrug
Oral capsule
PlaceboDrug
Oral capsule
| Study group | Role | What they receive |
|---|---|---|
| Norketotifen | Experimental | Norketotifen oral capsules, twice daily for 7 days Receives: Drug: Norketotifen |
| Placebo | Placebo comparator | Placebo oral capsules, twice daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 14 days
Secondary outcomes (9)
Time to resolution of fever (body temperature equal to or less than 37ºC)
Measured: 14 days
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14
Measured: 14 days
Change from baseline in composite symptom score at each time point through Day 14
Measured: 14 days
Body temperature at each time point through Day 14
Measured: 14 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Measured: 14 days
Time to resumption of normal activity
Measured: 14 days
Use of rescue medication (acetaminophen)
Measured: 14 days
Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)
Measured: 14 days
Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start14 Dec 2020
- Primary completion25 Jan 2022
- Study completion9 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emergo Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610047
- Sponsor's protocol ID
- NKT-203
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2020
- Last updated
- 30 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04610047
- Acronym / sponsor ID
- NKT-203
- Conditions
- Influenza, Influenza -Like Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Emergo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 9 Feb 2022 (actual)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norketotifen | Experimental | Drug: NorketotifenNorketotifen oral capsules, twice daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsules, twice daily for 7 days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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:
- 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
Key exclusion criteria (28 listed)
- 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):
- Presence of any severe or uncontrolled medical or psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NorketotifenOral capsule | Drug | Norketotifen |
| PlaceboOral capsule | Drug | Placebo |
Primary outcome
Time to alleviation of symptoms
Time frame: 14 days
Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
9 secondary outcomes
Time to resolution of fever (body temperature equal to or less than 37ºC)
Time frame: 14 days
Proportion of subjects whose symptoms have been alleviated at each time point through Day 14
Time frame: 14 days
Change from baseline in composite symptom score at each time point through Day 14
Time frame: 14 days
Body temperature at each time point through Day 14
Time frame: 14 days
Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)
Time frame: 14 days
Time to resumption of normal activity
Time frame: 14 days
Use of rescue medication (acetaminophen)
Time frame: 14 days
Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)
Time frame: 14 days
Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norketotifen in people with Influenza and Influenza -Like Illness, run by Emergo Therapeutics, Inc. at 20 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to alleviation of symptoms (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2023.