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A Clinical Trial of KT07 Capsule in the U.S.A

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02867358
Recruitment Status : Recruiting
First Posted : August 15, 2016
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Yiling Pharmaceutical Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Influenza, Human Drug: KT07 Capsule Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 2016
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Active Comparator: High dose of KT07 capsule
It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule

Active Comparator: 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).
Drug: KT07 Capsule
Other Name: Lianhua Qingwen Capsule

Other: Placebo
Placebo Comparator: Placebo
It will assess 140 subjects with influenza using 6 capsules of placebo each time, bid as control.
Other: Placebo



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. The reduction in duration of alleviation of individual symptom [ Time Frame: Up to 19 days ]
    From time zero to the time at which the symptom is less than or equal to mild and stable for at least 24 hours

  2. Quality of life assessment [ Time Frame: Up to 19 days ]
    Based on the self-assessment questionnaire


Other Outcome Measures:
  1. Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment [ Time Frame: Day 1 & 3 & 6 ]
    Reduction in viral shedding; Influenza viral AUC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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.
  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

  1. Subjects with severe influenza virus infection requiring inpatient treatment.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867358


Contacts
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Contact: Nan Zhang, PhD 614-441-7888 zhangnan@yilingus.net

Locations
Show Show 81 study locations
Sponsors and Collaborators
Yiling Pharmaceutical Inc.
Investigators
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Study Chair: Xuedong Gao, MD Yiling Pharmaceutical Inc.
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Responsible Party: Yiling Pharmaceutical Inc.
ClinicalTrials.gov Identifier: NCT02867358    
Other Study ID Numbers: KT07-US-01
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yiling Pharmaceutical Inc.:
acute uncomplicated influenza
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases