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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

391

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Sep 2016

Typical duration for phase_2

Geographic Reach

1 country

81 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.9 years study duration

First Submitted

Initial submission to the registry

August 10, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed

17 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed

Last Updated

August 31, 2020

Status Verified

August 1, 2020

Enrollment Period

3.9 years

First QC Date

August 10, 2016

Last Update Submit

August 27, 2020

Conditions

Influenza, Human

Keywords

acute uncomplicated influenza

Outcome Measures

Primary Outcomes (1)

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.
Up to 19 days

Secondary Outcomes (2)

The reduction in duration of alleviation of individual symptom
Up to 19 days
Quality of life assessment
Up to 19 days

Other Outcomes (1)

Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment
Day 1 & 3 & 6

Study Arms (3)

High dose of KT07 capsule

ACTIVE COMPARATOR

It will assess about 140 subjects with influenza at high dose KT07 (6 capsules each time, bid).

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).

Drug: KT07 CapsuleOther: Placebo

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

KT07 CapsuleDRUG

Also known as: Lianhua Qingwen Capsule

High dose of KT07 capsuleLow dose of KT07 capsule

PlaceboOTHER

Low dose of KT07 capsulePlacebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Yiling Pharmaceutical Inc.lead

Study Sites (81)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Parkway Medical Center, LLC

Birmingham, Alabama, 35215, United States

Location

Cahaba Research, Inc.

Birmingham, Alabama, 35242, United States

Location

David Wever

Pelham, Alabama, 35124, United States

Location

Alliane Urgent Care

Tolleson, Arizona, 85353, United States

Location

Orange County Research Institute

Anaheim, California, 92801, United States

Location

Hope Clinical Research, Inc.

Canoga Park, California, 91303, United States

Location

Core Health Care Group

Cerritos, California, 90703, United States

Location

Aviva Research

Escondido, California, 90205, United States

Location

Lalla-Reddy Medical Corp.

Fountain Valley, California, 92708, United States

Location

Research Center of Fresno, Inc.

Fresno, California, 93702, United States

Location

Ark Clinical Research

Long Beach, California, 90806, United States

Location

Long Beach Clinical Trials Services, Inc

Long Beach, California, 90806, United States

Location

Downtown L.A. Research Center, Inc.

Los Angeles, California, 90017, United States

Location

IMD Medical Group

Los Angeles, California, 90020, United States

Location

Facey Medical Foundation

Mission Hills, California, 91345, United States

Location

MD Strategies Research Centers

San Diego, California, 92119, United States

Location

Empire Clinical Research

Upland, California, 91786, United States

Location

Cherry Creek Family Practice, PLLC

Denver, Colorado, 80246, United States

Location

Urgent Care-Denver

Denver, Colorado, 80246, United States

Location

Clinical Research Consulting

Milford, Connecticut, 06460, United States

Location

Comprehensive Psychiatric Center

Norwich, Connecticut, 06360, United States

Location

Doral Medical Research

Doral, Florida, 33166, United States

Location

Finlay Medical Research Corp.

Miami, Florida, 33126, United States

Location

Panamerican Health Center, Inc.

Miami, Florida, 33126, United States

Location

AppleMed Reseach, Inc.

Miami, Florida, 33155, United States

Location

Research Institute of South Florida, Inc.

Miami, Florida, 33173, United States

Location

Florida Research Center, Inc.

Miami, Florida, 33174, United States

Location

Sweet Hope Research Specialty, Inc

Miami Lakes, Florida, 33016, United States

Location

Sunrise Medical Research

Tamarac, Florida, 33351, United States

Location

Sunrise Medical Research

West Palm Beach, Florida, 33406, United States

Location

Southeast Clinical Research

Williston, Florida, 32696, United States

Location

Invocare (Savannah GA location)

Rincon, Georgia, 31326, United States

Location

Infinite Clinical Trials

Riverdale, Georgia, 30274, United States

Location

The Blackfoot Medical Center - Blackfoot

Blackfoot, Idaho, 83221, United States

Location

Buynak Clinical Research, P.C.

Valparaiso, Indiana, 46383, United States

Location

Horizon Research Group of Opelousas, LLC

Eunice, Louisiana, 70535, United States

Location

Centex Studies, Inc

Lake Charles, Louisiana, 70601, United States

Location

MedPharmics, LLC

Metairie, Louisiana, 70006, United States

Location

Centennial Medical Group

Elkridge, Maryland, 21075, United States

Location

MD Medical Research

Oxon Hill, Maryland, 20745, United States

Location

Romedica LLC

Rochester, Michigan, 48307, United States

Location

Olive Branch Family Medical Center

Olive Branch, Mississippi, 38654, United States

Location

Mercury Street Medical Group, PLLC

Butte, Montana, 59701, United States

Location

Red Rock Clinical Research, LLC

Las Vegas, Nevada, 89146, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

New York Clinical Trials

Manhattan, New York, 10018, United States

Location

Carolina Research Center, Inc

Shelby, North Carolina, 28150, United States

Location

Ardmore Family Practice

Winston-Salem, North Carolina, 27103, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

META Medical Research Institute, LLC

Dayton, Ohio, 45432, United States

Location

Medical Research International

Oklahoma City, Oklahoma, 73109, United States

Location

Detweiler Family Medicine

Lansdale, Pennsylvania, 19446, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Frontier Clinical Research, LLC

Smithfield, Pennsylvania, 15478, United States

Location

American Family Care Urgent Care

Chattanooga, Tennessee, 37421, United States

Location