Influenza, Human Clinical Trial
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
Verified date | August 2020 |
Source | Yiling Pharmaceutical Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 391 |
Est. completion date | July 31, 2020 |
Est. primary completion date | July 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | Orange County Research Institute | Anaheim | California |
United States | Premier Family Physicians | Austin | Texas |
United States | Pioneer Research Solutions | Beaumont | Texas |
United States | Hassman Research Institute | Berlin | New Jersey |
United States | Cahaba Research, Inc. | Birmingham | Alabama |
United States | Central Alabama Research | Birmingham | Alabama |
United States | Parkway Medical Center, LLC | Birmingham | Alabama |
United States | The Blackfoot Medical Center - Blackfoot | Blackfoot | Idaho |
United States | Wade Family Medicine | Bountiful | Utah |
United States | Mercury Street Medical Group, PLLC | Butte | Montana |
United States | Hope Clinical Research, Inc. | Canoga Park | California |
United States | Family Medicine Associates of Texas | Carrollton | Texas |
United States | Core Health Care Group | Cerritos | California |
United States | American Family Care Urgent Care | Chattanooga | Tennessee |
United States | New Horizons Clinical Research | Cincinnati | Ohio |
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 | META Medical Research Institute, LLC | Dayton | Ohio |
United States | Cherry Creek Family Practice, PLLC | Denver | Colorado |
United States | Urgent Care-Denver | Denver | Colorado |
United States | Doral Medical Research | Doral | Florida |
United States | J. Lewis Research, Inc./ Foothill Family Clinic Draper | Draper | Utah |
United States | Centennial Medical Group | Elkridge | Maryland |
United States | Aviva Research | Escondido | California |
United States | Horizon Research Group of Opelousas, LLC | Eunice | Louisiana |
United States | Lalla-Reddy Medical Corp. | Fountain Valley | California |
United States | Clinical Research Solutions, LLC | Franklin | Tennessee |
United States | Research Center of Fresno, Inc. | Fresno | California |
United States | AccuMed Research Associates | Garden City | New York |
United States | Centex Studies, Inc. | Houston | Texas |
United States | Clinical Research Solutions, LLC | Jackson | Tennessee |
United States | Centex Studies, Inc | Lake Charles | Louisiana |
United States | Detweiler Family Medicine | Lansdale | Pennsylvania |
United States | Red Rock Clinical Research, LLC | Las Vegas | Nevada |
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 | New York Clinical Trials | Manhattan | New York |
United States | Centex Studies, Inc. | McAllen | Texas |
United States | MedPharmics, LLC | Metairie | Louisiana |
United States | AppleMed Reseach, Inc. | Miami | Florida |
United States | Finlay Medical Research Corp. | Miami | Florida |
United States | Florida Research Center, Inc. | Miami | Florida |
United States | Panamerican Health Center, Inc. | Miami | Florida |
United States | Research Institute of South Florida, Inc. | Miami | Florida |
United States | Sweet Hope Research Specialty, Inc | Miami Lakes | Florida |
United States | Clinical Research Consulting | Milford | Connecticut |
United States | Facey Medical Foundation | Mission Hills | California |
United States | Clinical Research Solutions, LLC | Nashville | Tennessee |
United States | Comprehensive Psychiatric Center | Norwich | Connecticut |
United States | Medical Research International | Oklahoma City | Oklahoma |
United States | Olive Branch Family Medical Center | Olive Branch | Mississippi |
United States | MD Medical Research | Oxon Hill | Maryland |
United States | David Wever | Pelham | Alabama |
United States | Village Health Partners | Plano | Texas |
United States | Clinical Research Partners | Richmond | Virginia |
United States | Invocare (Savannah GA location) | Rincon | Georgia |
United States | Infinite Clinical Trials | Riverdale | Georgia |
United States | Romedica LLC | Rochester | Michigan |
United States | Chrysalis Clinical Research | Saint George | 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 | Bandera Family Health Clinic | San Antonio | Texas |
United States | Quaity Assurance Research Center | San Antonio | Texas |
United States | MD Strategies Research Centers | San Diego | California |
United States | Frontier Clinical Research, LLC | Scottdale | Pennsylvania |
United States | Carolina Research Center, Inc | Shelby | North Carolina |
United States | Frontier Clinical Research, LLC | Smithfield | Pennsylvania |
United States | Clinical Research Solutions, LLC | Smyrna | Tennessee |
United States | CopperView Medical Center | South Jordan | Utah |
United States | Clinical Research Solutions, LLC | Spring Hill | Tennessee |
United States | Sunrise Medical Research | Tamarac | Florida |
United States | Alliane Urgent Care | Tolleson | Arizona |
United States | Empire Clinical Research | Upland | California |
United States | Buynak Clinical Research, P.C. | Valparaiso | Indiana |
United States | Sunrise Medical Research | West Palm Beach | Florida |
United States | Southeast Clinical Research | Williston | Florida |
United States | Ardmore Family Practice | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Yiling Pharmaceutical Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Influenza viral shedding from baseline to Day 3 and Day 6 post treatment initiation during KT07 treatment | Reduction in viral shedding; Influenza viral AUC | Day 1 & 3 & 6 | |
Primary | 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 | 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 | Up to 19 days | |
Secondary | Quality of life assessment | Based on the self-assessment questionnaire | Up to 19 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03275389 -
A Study to Evaluate the Reactogenicity, Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Investigational Supra-seasonal Universal Influenza Vaccines - Inactivated (SUIVs) (GSK3816302A) in Healthy Adults Aged 18 to 39 Years
|
Phase 1 | |
Completed |
NCT03442582 -
Afluria Pregnancy Registry
|
||
Completed |
NCT05981846 -
A Phase II Trial to Evaluate the Safety and Immunogenicity of BIMERVAX® When Coadministered With Seasonal Influenza Vaccine (SIIV) in Adults Older Than 65 Years of Age Fully Vaccinated Against COVID-19
|
Phase 2 | |
Completed |
NCT05044195 -
A Clinical Study to Evaluate the Immunogenicity and Safety of an Adjuvanted Quadrivalent Influenza Vaccine Compared With a Licensed Quadrivalent Vaccine in Adults 50 to 64 Years of Age
|
Phase 3 | |
Completed |
NCT02914275 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.
|
Phase 3 | |
Completed |
NCT04590066 -
Testing Multiple Behavioral Science Strategies to Increase Flu-Shot Rates at a Large Retail Pharmacy
|
N/A | |
Recruiting |
NCT03778203 -
Development of Childhood Anti-influenza Immunity
|
Phase 4 | |
Completed |
NCT04527614 -
Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection
|
N/A | |
Terminated |
NCT03658629 -
Phase 2 Dose and Formulation Confirmation of Quad-NIV in Older Adults
|
Phase 2 | |
Completed |
NCT05269290 -
Efficacy and Safety of Ingavirin®, Syrup, 30 mg/5 ml, in Children With Influenza and Other Acute Respiratory Viral Infections
|
Phase 3 | |
Completed |
NCT06385821 -
A Study to Prove Non-inferior Immunogenicity of Grippol Quadrivalent Compared to Grippol Plus
|
Phase 3 | |
Completed |
NCT02998996 -
Study to Assess the Safety, Tolerability and Immune Response Following Vaccination With Immunose™ FLU
|
Phase 1/Phase 2 | |
Withdrawn |
NCT02883972 -
Childhood Influenza Immunisation Invitation Trial in Schools
|
N/A | |
Completed |
NCT02984280 -
Specific Respiratory Infections as Triggers of Acute Medical Events
|
N/A | |
Completed |
NCT02545543 -
A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 5 Through 17 Years of Age
|
Phase 3 | |
Completed |
NCT02621164 -
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents
|
Phase 3 | |
Completed |
NCT02212106 -
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
|
Phase 4 | |
Completed |
NCT02243774 -
Mail Outreach To Increase Vaccination Acceptance Through Engagement
|
N/A | |
Completed |
NCT02344134 -
Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects
|
Phase 3 | |
Completed |
NCT01674205 -
Study of Immune Responses in Healthy Adults Receiving Live Influenza Virus Vaccines
|
Phase 1 |