Influenza -Like IllnessPhase 2NCT04043923
Norketotifen for the Treatment of Uncomplicated Influenza-like Illness
A Phase 2 study testing Norketotifen in people with Influenza -Like Illness, run by Emergo Therapeutics, Inc. at 18 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 -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
- 238 participants
- Where
- 18 sitesUnited States
- Study dates
- 21 Oct 2019to 20 Apr 2020
- 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) 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
- The time interval between the onset of symptoms and the predose examinations is ≤96 hours. The onset of symptoms is defined as either:
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- 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
- Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol
Who cannot join
- 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):
- Residents of nursing homes or other long-term care facilities
- American Indians and Alaska natives
- Asthma
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- 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)
- 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
- Female subjects who are pregnant or breastfeeding
- Any clinically significant electrocardiogram test
- Received baloxavir, oseltamivir, peramivir, zanamivir, rimantadine, or amantadine within 30 days prior to the pre-dose examinations
- Received an investigational monoclonal antibody for a viral disease in the last year prior to the pre-dose examinations
- Received ketotifen fumarate, cromolyn sodium, or nedocromil sodium by any route of administration within 30 days prior to the pre-dose examinations
- Exposure to an investigational drug within 30 days prior to the pre-dose examinations
- History of allergic reaction to ketotifen
- Any prior exposure to norketotifen
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Premier Family Physicians
Austin, Texas, 78735
DelRicht Research
Baton Rouge, Louisiana, 70809
Cahaba Research
Birmingham, Alabama, 35235
Family Medicine Associates of Texas
Carrollton, Texas, 75010
OnSite Clinical Solutions
Charlotte, North Carolina, 28277
CityDoc Urgent Care
Dallas, Texas, 75204
AFC Urgent Care
Denver, Colorado, 80246
Long Beach Clinical Trial Services
Long Beach, California, 90806
South Florida Research Center
Miami, Florida, 33135
Premier Research Associate
Miami, Florida, 33165
DelRicht Research
New Orleans, Louisiana, 70124
Precision Trials AZ
Phoenix, Arizona, 85032
Village Health Partners
Plano, Texas, 75024
Empire Clinical Research
Pomona, California, 91767
Health Concepts
Rapid City, South Dakota, 57702
Northern California Research
Sacramento, California, 95821
The Clinical Research Center
St Louis, Missouri, 63141
Gulfcoast Medical Research
Tampa, Florida, 33607
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 -Like Illness
- Being tested
- Norketotifen, Placebo
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, once daily for 5 days Receives: Drug: Norketotifen |
| Placebo | Placebo comparator | Placebo oral capsules, once daily for 5 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 (7)
Proportion of subjects whose symptoms have been alleviated at each time point through Day 5
Measured: 5 days
Change from baseline in composite symptom score at each time point through Day 5
Measured: 5 days
Time to resolution of fever (body temperature equal to or less than 37ºC)
Measured: 14 days
Body temperature at each time point through Day 5
Measured: 5 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2019
- Study start21 Oct 2019
- Primary completion5 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza -Like IllnessStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 238 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
- NCT04043923
- Sponsor's protocol ID
- NKT-202
- Status last verified
- Mar 2021
- First submitted
- 1 Aug 2019
- Last updated
- 24 Mar 2021
- 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 24 Mar 2021. 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
- NCT04043923
- Acronym / sponsor ID
- NKT-202
- Conditions
- Influenza -Like Illness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Emergo Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2019 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 2 Aug 2019 (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
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Norketotifen | Experimental | Drug: NorketotifenNorketotifen oral capsules, once daily for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo oral capsules, once daily for 5 days |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 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:
- The time interval between the onset of symptoms and the predose examinations is ≤96 hours. The onset of symptoms is defined as either:
- Females of childbearing potential and males agree to use an appropriate method of contraception as detailed in the protocol
Key exclusion criteria (28 listed)
- 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
- History of or current autoimmune disease
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)
7 secondary outcomes
Proportion of subjects whose symptoms have been alleviated at each time point through Day 5
Time frame: 5 days
Change from baseline in composite symptom score at each time point through Day 5
Time frame: 5 days
Time to resolution of fever (body temperature equal to or less than 37ºC)
Time frame: 14 days
Body temperature at each time point through Day 5
Time frame: 5 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
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 24 Mar 2021.
- 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.
18 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 -Like Illness, run by Emergo Therapeutics, Inc. at 18 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 9 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 24 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 24 Mar 2021.