Influenza, HumanPhase 2NCT02867358
A Clinical Trial of KT07 Capsule in the U.S.A
A Phase 2 study testing KT07 Capsule in people with Influenza, Human, run by Yiling Pharmaceutical Inc. at 81 sites in United States.
Trial summary
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Influenza, Human
- What is being tested?
- KT07 Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 391 participants
- Where
- 81 sitesUnited States
- Study dates
- Sep 2016to 31 Jul 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with acute uncomplicated influenza with oral temperature ≥ 37.8 ℃ (100.04 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
- Subjects with RIDT confirmed influenza infection.
- Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:
- Time of the first increase in body temperature to ≥ 37.8 ℃ (100.04 °F); or
- Time when the subject experiences at least one general or respiratory symptom.
- Age 18 to 65 years old.
- Subjects who are able to understand and willing to sign the informed consent form (ICF).
- All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicide or condom + diaphragm with spermicide, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation.
Who cannot join
- Subjects with severe influenza virus infection requiring inpatient treatment.
- Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the time of screening.
- Subjects who have any of the following documented conditions: uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg), diabetes, asthma (any current or recent, not childhood if resolved), COPD (any), cardiac, hepatic, renal (including eGFR<60) and hematopoietic disorders, bleeding tendency or hemorrhagic disease, neurological system disease, compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer within the past 5 years or human immunodeficiency virus [HIV] infection), endocrine disorders (including thyroid disorders).
- Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
- Clinically obese subjects with BMI≥40.
- Subjects with recent history (within 1 year) of alcoholism or substance abuse.
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- Received influenza vaccine within 21 days.
- Participation in other clinical trial within 1 month, or during the study.
- Pregnant or breast-feeding female subjects
- Allergy or known allergy to components of study medication.
- Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to enrollment.
- Previous history of difficulty swallowing capsules.
- Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results.
Trial locations and contacts
81 sites in 1 country.
81 sites in 1 country
United States81 sites
Orange County Research Institute
Anaheim, California, 92801
Premier Family Physicians
Austin, Texas, 78735
Pioneer Research Solutions
Beaumont, Texas, 77702
Hassman Research Institute
Berlin, New Jersey, 08009
Central Alabama Research
Birmingham, Alabama, 35209
Parkway Medical Center, LLC
Birmingham, Alabama, 35215
Cahaba Research, Inc.
Birmingham, Alabama, 35242
The Blackfoot Medical Center - Blackfoot
Blackfoot, Idaho, 83221
Wade Family Medicine
Bountiful, Utah, 84010
Mercury Street Medical Group, PLLC
Butte, Montana, 59701
Hope Clinical Research, Inc.
Canoga Park, California, 91303
Family Medicine Associates of Texas
Carrollton, Texas, 75010
Core Health Care Group
Cerritos, California, 90703
American Family Care Urgent Care
Chattanooga, Tennessee, 37421
New Horizons Clinical Research
Cincinnati, Ohio, 45242
Corpus Christi Family Wellness
Corpus Christi, Texas, 78414
Northwest Med Care
Cypress, Texas, 77429
City Doc Urgent Care
Dallas, Texas, 75230
META Medical Research Institute, LLC
Dayton, Ohio, 45432
Cherry Creek Family Practice, PLLC
Denver, Colorado, 80246
Urgent Care-Denver
Denver, Colorado, 80246
Doral Medical Research
Doral, Florida, 33166
J. Lewis Research, Inc./ Foothill Family Clinic Draper
Draper, Utah, 84020
Centennial Medical Group
Elkridge, Maryland, 21075
Aviva Research
Escondido, California, 90205
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, 70535
Lalla-Reddy Medical Corp.
Fountain Valley, California, 92708
Clinical Research Solutions, LLC
Franklin, Tennessee, 37067
Research Center of Fresno, Inc.
Fresno, California, 93702
AccuMed Research Associates
Garden City, New York, 11530
Centex Studies, Inc.
Houston, Texas, 77058
Clinical Research Solutions, LLC
Jackson, Tennessee, 38305
Centex Studies, Inc
Lake Charles, Louisiana, 70601
Detweiler Family Medicine
Lansdale, Pennsylvania, 19446
Red Rock Clinical Research, LLC
Las Vegas, Nevada, 89146
Ark Clinical Research
Long Beach, California, 90806
Long Beach Clinical Trials Services, Inc
Long Beach, California, 90806
Downtown L.A. Research Center, Inc.
Los Angeles, California, 90017
IMD Medical Group
Los Angeles, California, 90020
New York Clinical Trials
Manhattan, New York, 10018
Centex Studies, Inc.
McAllen, Texas, 78504
MedPharmics, LLC
Metairie, Louisiana, 70006
Finlay Medical Research Corp.
Miami, Florida, 33126
Panamerican Health Center, Inc.
Miami, Florida, 33126
AppleMed Reseach, Inc.
Miami, Florida, 33155
Research Institute of South Florida, Inc.
Miami, Florida, 33173
Florida Research Center, Inc.
Miami, Florida, 33174
Sweet Hope Research Specialty, Inc
Miami Lakes, Florida, 33016
Clinical Research Consulting
Milford, Connecticut, 06460
Facey Medical Foundation
Mission Hills, California, 91345
Clinical Research Solutions, LLC
Nashville, Tennessee, 37211
Comprehensive Psychiatric Center
Norwich, Connecticut, 06360
Medical Research International
Oklahoma City, Oklahoma, 73109
Olive Branch Family Medical Center
Olive Branch, Mississippi, 38654
MD Medical Research
Oxon Hill, Maryland, 20745
David Wever
Pelham, Alabama, 35124
Village Health Partners
Plano, Texas, 75024
Clinical Research Partners
Richmond, Virginia, 23220
Invocare (Savannah GA location)
Rincon, Georgia, 31326
Infinite Clinical Trials
Riverdale, Georgia, 30274
Romedica LLC
Rochester, Michigan, 48307
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121
J. Lewis Research, Inc./ FirstMed East
Salt Lake City, Utah, 84121
Quaity Assurance Research Center
San Antonio, Texas, 78207
Bandera Family Health Clinic
San Antonio, Texas, 78249
MD Strategies Research Centers
San Diego, California, 92119
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, 15683
Carolina Research Center, Inc
Shelby, North Carolina, 28150
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
Clinical Research Solutions, LLC
Smyrna, Tennessee, 37167
CopperView Medical Center
South Jordan, Utah, 84095
Clinical Research Solutions, LLC
Spring Hill, Tennessee, 37174
Chrysalis Clinical Research
St. George, Utah, 84790
Sunrise Medical Research
Tamarac, Florida, 33351
Alliane Urgent Care
Tolleson, Arizona, 85353
Empire Clinical Research
Upland, California, 91786
Buynak Clinical Research, P.C.
Valparaiso, Indiana, 46383
Sunrise Medical Research
West Palm Beach, Florida, 33406
Southeast Clinical Research
Williston, Florida, 32696
Ardmore Family Practice
Winston-Salem, North Carolina, 27103
About this study
Official title: A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.
- Conditions
- Influenza, Human
- Being tested
- KT07 Capsule, Placebo
- Keywords
- acute uncomplicated influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KT07 CapsuleDrug
Also called Lianhua Qingwen Capsule
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| High dose of KT07 capsule | Active comparator | It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid). Receives: Drug: KT07 Capsule |
| Low dose of KT07 capsule | Active comparator | It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid). Receives: Drug: KT07 Capsule; Other: Placebo |
| Placebo | Placebo comparator | It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the improvement in reducing the duration of illness compared to placebo.
Duration of illness is defined as: the length of time to alleviation of all symptoms.
The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.
Measured: Up to 19 days
Secondary outcomes (2)
The reduction in duration of alleviation of individual symptom
From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours
Measured: Up to 19 days
Quality of life assessment
Based on the self-assessment questionnaire
Measured: Up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2016 (estimated)
- Study startSep 2016
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza, HumanStudies 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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yiling Pharmaceutical Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xuedong Gao, MD, Study director, Yiling Pharmaceutical Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02867358
- Sponsor's protocol ID
- KT07-US-01
- Status last verified
- Aug 2020
- First submitted
- 10 Aug 2016
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, and Placebo-controlled Phase II Clinical Study to Investigate the Safety and Efficacy of Two Doses of KT07 Compared to Placebo in Subjects With Acute Uncomplicated Influenza
- ClinicalTrials.gov ID
- NCT02867358
- Acronym / sponsor ID
- KT07-US-01
- Conditions
- Influenza, Human
- Keywords
- acute uncomplicated influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Yiling Pharmaceutical Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 15 Aug 2016 (estimated)
- 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.
The purpose of this study is to investigate clinical efficacy of KT07 capsule in alleviation of fever and other symptoms including nasal congestion, sore throat, cough, aches and pains, fatigue, headache, chills or sweats in subjects with acute uncomplicated influenza.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose of KT07 capsule | Active comparator | Drug: KT07 CapsuleIt will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid). |
| Low dose of KT07 capsule | Active comparator | Drug: KT07 Capsule, Other: PlaceboIt will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid). |
| Placebo | Placebo comparator | Other: PlaceboIt will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with acute uncomplicated influenza with oral temperature ≥ 37.8 ℃ (100.04 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed.
- Subjects with RIDT confirmed influenza infection.
- Onset of symptoms less than 48 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either:
- Age 18 to 65 years old.
- Subjects who are able to understand and willing to sign the informed consent form (ICF).
Key exclusion criteria (13 listed)
- Subjects with severe influenza virus infection requiring inpatient treatment.
- Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the time of screening.
- Subjects who have any of the following documented conditions: uncontrolled hypertension (systolic blood pressure > 140 mm Hg or diastolic blood pressure > 90 mm Hg), diabetes, asthma (any current or recent, not childhood if resolved), COPD (any), cardiac, hepatic, renal (including eGFR<60) and hematopoietic disorders, bleeding tendency or hemorrhagic disease, neurological system disease, compromised immune system (including patients receiving immunosuppressant therapy, or those with cancer within the past 5 years or human immunodeficiency virus [HIV] infection), endocrine disorders (including thyroid disorders).
- Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
- Clinically obese subjects with BMI≥40.
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 |
|---|---|---|
| KT07 CapsuleAlso: Lianhua Qingwen Capsule | Drug | High dose of KT07 capsule, Low dose of KT07 capsule |
| Placebo | Other | Low dose of KT07 capsule, Placebo |
Primary outcome
To investigate the improvement in reducing the duration of illness compared to placebo.
Time frame: Up to 19 days
Duration of illness is defined as: the length of time to alleviation of all symptoms. The duration of alleviation is calculated from time 0 (first administration of study medication) to the time at which symptom is alleviated.
2 secondary outcomes
The reduction in duration of alleviation of individual symptom
Time frame: Up to 19 days
Quality of life assessment
Time frame: Up to 19 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 31 Aug 2020.
- 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.
Xuedong Gao, MD study director
Yiling Pharmaceutical Inc.
81 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 KT07 Capsule in people with Influenza, Human, run by Yiling Pharmaceutical Inc. at 81 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 13 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 31 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 81 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?
To investigate the improvement in reducing the duration of illness compared to placebo. (time frame: Up to 19 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 31 Aug 2020.