Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
391 participants
INTERVENTIONAL
2016-09-30
2020-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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High dose of KT07 capsule
It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).
KT07 Capsule
Low dose of KT07 capsule
It will assess about 140 subjects with influenza at low dose KT07 (4 capsules of KT07 + 2 capsules of placebo each time, bid).
KT07 Capsule
Placebo
Placebo
It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.
Placebo
Interventions
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KT07 Capsule
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects with RIDT confirmed influenza infection.
3. 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.
4. Age 18 to 65 years old.
5. Subjects who are able to understand and willing to sign the informed consent form (ICF).
6. 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.
Exclusion Criteria
2. Subjects with concurrent infections requiring systemic antimicrobial and/or antiviral therapy at the time of screening.
3. 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).
4. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation.
5. Clinically obese subjects with BMI≥40.
6. Subjects with recent history (within 1 year) of alcoholism or substance abuse.
7. Received influenza vaccine within 21 days.
8. Participation in other clinical trial within 1 month, or during the study.
9. Pregnant or breast-feeding female subjects
10. Allergy or known allergy to components of study medication.
11. Subjects who took a monoamine oxidase inhibitor (MAOI) within 2 weeks prior to enrollment.
12. Previous history of difficulty swallowing capsules.
13. 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.
18 Years
65 Years
ALL
No
Sponsors
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Yiling Pharmaceutical Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Xuedong Gao, MD
Role: STUDY_DIRECTOR
Yiling Pharmaceutical Inc.
Locations
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Central Alabama Research
Birmingham, Alabama, United States
Parkway Medical Center, LLC
Birmingham, Alabama, United States
Cahaba Research, Inc.
Birmingham, Alabama, United States
David Wever
Pelham, Alabama, United States
Alliane Urgent Care
Tolleson, Arizona, United States
Orange County Research Institute
Anaheim, California, United States
Hope Clinical Research, Inc.
Canoga Park, California, United States
Core Health Care Group
Cerritos, California, United States
Aviva Research
Escondido, California, United States
Lalla-Reddy Medical Corp.
Fountain Valley, California, United States
Research Center of Fresno, Inc.
Fresno, California, United States
Ark Clinical Research
Long Beach, California, United States
Long Beach Clinical Trials Services, Inc
Long Beach, California, United States
Downtown L.A. Research Center, Inc.
Los Angeles, California, United States
IMD Medical Group
Los Angeles, California, United States
Facey Medical Foundation
Mission Hills, California, United States
MD Strategies Research Centers
San Diego, California, United States
Empire Clinical Research
Upland, California, United States
Cherry Creek Family Practice, PLLC
Denver, Colorado, United States
Urgent Care-Denver
Denver, Colorado, United States
Clinical Research Consulting
Milford, Connecticut, United States
Comprehensive Psychiatric Center
Norwich, Connecticut, United States
Doral Medical Research
Doral, Florida, United States
Finlay Medical Research Corp.
Miami, Florida, United States
Panamerican Health Center, Inc.
Miami, Florida, United States
AppleMed Reseach, Inc.
Miami, Florida, United States
Research Institute of South Florida, Inc.
Miami, Florida, United States
Florida Research Center, Inc.
Miami, Florida, United States
Sweet Hope Research Specialty, Inc
Miami Lakes, Florida, United States
Sunrise Medical Research
Tamarac, Florida, United States
Sunrise Medical Research
West Palm Beach, Florida, United States
Southeast Clinical Research
Williston, Florida, United States
Invocare (Savannah GA location)
Rincon, Georgia, United States
Infinite Clinical Trials
Riverdale, Georgia, United States
The Blackfoot Medical Center - Blackfoot
Blackfoot, Idaho, United States
Buynak Clinical Research, P.C.
Valparaiso, Indiana, United States
Horizon Research Group of Opelousas, LLC
Eunice, Louisiana, United States
Centex Studies, Inc
Lake Charles, Louisiana, United States
MedPharmics, LLC
Metairie, Louisiana, United States
Centennial Medical Group
Elkridge, Maryland, United States
MD Medical Research
Oxon Hill, Maryland, United States
Romedica LLC
Rochester, Michigan, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
Mercury Street Medical Group, PLLC
Butte, Montana, United States
Red Rock Clinical Research, LLC
Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
AccuMed Research Associates
Garden City, New York, United States
New York Clinical Trials
Manhattan, New York, United States
Carolina Research Center, Inc
Shelby, North Carolina, United States
Ardmore Family Practice
Winston-Salem, North Carolina, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
META Medical Research Institute, LLC
Dayton, Ohio, United States
Medical Research International
Oklahoma City, Oklahoma, United States
Detweiler Family Medicine
Lansdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Scottdale, Pennsylvania, United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, United States
American Family Care Urgent Care
Chattanooga, Tennessee, United States
Clinical Research Solutions, LLC
Franklin, Tennessee, United States
Clinical Research Solutions, LLC
Jackson, Tennessee, United States
Clinical Research Solutions, LLC
Nashville, Tennessee, United States
Clinical Research Solutions, LLC
Smyrna, Tennessee, United States
Clinical Research Solutions, LLC
Spring Hill, Tennessee, United States
Premier Family Physicians
Austin, Texas, United States
Pioneer Research Solutions
Beaumont, Texas, United States
Family Medicine Associates of Texas
Carrollton, Texas, United States
Corpus Christi Family Wellness
Corpus Christi, Texas, United States
Northwest Med Care
Cypress, Texas, United States
City Doc Urgent Care
Dallas, Texas, United States
Centex Studies, Inc.
Houston, Texas, United States
Centex Studies, Inc.
McAllen, Texas, United States
Village Health Partners
Plano, Texas, United States
Quaity Assurance Research Center
San Antonio, Texas, United States
Bandera Family Health Clinic
San Antonio, Texas, United States
Wade Family Medicine
Bountiful, Utah, United States
J. Lewis Research, Inc./ Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc./ FirstMed East
Salt Lake City, Utah, United States
CopperView Medical Center
South Jordan, Utah, United States
Chrysalis Clinical Research
St. George, Utah, United States
Clinical Research Partners
Richmond, Virginia, United States
Countries
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Other Identifiers
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KT07-US-01
Identifier Type: -
Identifier Source: org_study_id
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