Study to Assess Efficacy and Safety of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections
Multicenter Double-blinded Placebo-Controlled Parallel-Group Randomized Clinical Trial of Efficacy, Safety and Choice of an Optimum Dose of XC221 in the Treatment of Influenza and Other Acute Respiratory Viral Infections in Adults
A multicenter double-blinded, randomized, placebo-controlled, parallel-group comparative Phase II clinical study to assess safety, tolerability, efficacy and optimal dose of XC221 vs. placebo in patients with uncomplicated influenza or other ARVI during a 3-day treatment.
The primary objective of the study is to demonstrate the difference in time before the onset of a sustained improvement in clinical symptoms according to the Modified Jackson Scale for ARVI and to determine the optimal dose of XC221 in the treatment of influenza and other ARVI.
研究概览
详细说明
11 Russian centers were planned for participation in this study. The study consists of three periods: screening, treatment and follow-up.
All eligible patients will be randomized into 3 groups (groups A, B and C) in a 1:1:1 ratio:
Group A - XC221 100 mg daily (40 patients); Group B - XC221 200 mg daily (40 patients); Group C - Placebo (40 patients).
During the treatment period (3 days), patients will receive XC221 / placebo daily on a background of standard symptomatic therapy. The follow-up period lasts for 11 days.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Izhevsk、俄罗斯联邦、426063
- City Clinical Hospital №9
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Krasnodar、俄罗斯联邦、350063
- Kuban State Medical University
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Rostov-on-Don、俄罗斯联邦、344000
- City Clinical Hospital №1 n.a. Semashko
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Ryazan'、俄罗斯联邦、390026
- Ryazan State Medical University n.a. Pavlov
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Saint Petersburg、俄罗斯联邦、190103
- The Center for Prevention and Fight about AIDS and Infectious Diseases
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Saint Petersburg、俄罗斯联邦、197110
- The Consulting and Diagnostic Center with out-patient help of the Administration of the President of the Russian Federation
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Saint Petersburg、俄罗斯联邦、197376
- Research Institute of Influenza
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Saint Petersburg、俄罗斯联邦、197706
- City Clinical Hospital №40 of Kurortny District
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Saransk、俄罗斯联邦、430024
- Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
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Volgograd、俄罗斯联邦、400131
- Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
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Yaroslavl、俄罗斯联邦、150007
- Сlinical Hospital №3
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men and women aged 18 to 45 years (inclusively).
- Clinically diagnosed influenza or ARVI.
- Patient's body temperature ≥37.5ºС and at least 1 symptom from Modified Jackson Scale estimated more than 2 points.
- Uncomplicated course of influenza or ARVI based on clinical estimations.
- The first 36 hours from the beginning of symptoms of influenza or ARVI.
- Women of reproductive age (who are not in menopause and who have not undergone surgical sterilization) and men who have sexual activity should use a reliable method of contraception (acceptable methods of contraception in this study are: intrauterine devices, oral contraceptives, contraceptive patch, long-acting injectable contraceptives, a double barrier method (condom and diaphragm with spermicide) throughout the study period.
- Compliance with the treatment regimen, visits and laboratory examinations provided by the protocol.
- Signed Informed Consent Form.
Exclusion Criteria:
- Existence of complications of influenza or ARVI (including the presence / development of bacterial infection).
- Hypersensitivity to excipients of the drug XC221 or placebo.
- Antiviral medications in 7 days prior to screening (antiviral agents, interferons and interferon inducers, drugs that have immunomodulating action) or anti-infective agents of systemic or local action.
- Severe infection with signs of cardiovascular insufficiency development and other manifestations of infectious-toxic shock, as well as with the presence of neuroinfection syndrome (encephalic and meningoencephalic reactions, polyradiculoneuritis, neuritis).
- Signs of the development of viral pneumonia (the presence of two or more of the following symptoms): dyspnea, chest pain when coughing, systemic cyanosis, dullness of percussion sound with a symmetrical evaluation of the upper and lower sections of the lungs).
- Infectious diseases during the last week before including into the study.
- History of bronchial asthma.
- History of increased convulsive activity.
- Severe, decompensated or unstable somatic diseases (any diseases or conditions that are life-threatening or may worsen the patient's prognosis, and make him/her ineligible for the clinical study).
- History of oncological diseases, HIV, tuberculosis.
- Diabetes mellitus.
- Drug or alcohol abuse.
- Participation in any other clinical trial in the last 90 days.
- Pregnancy or lactation.
- Military or prison populations.
- Impossibility or inability to comply with the study procedures.
- A member of the investigator's family or other person interested in the results of the study.
- Abnormal laboratory results, which, according to the study doctor, interfere with the patient's inclusion in the study.
- History of renal insufficiency.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：XC221 100 mg
XC221 100 mg orally. 1 tablet of XC221 100 mg +1 tablet of Placebo 100 mg (in total 2 tablets) once daily during 3 days of treatment period |
once daily during 3 days.
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实验性的：XC221 200 mg
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
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once daily during 3 days.
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安慰剂比较：Placebo
Placebo orally. 2 tablets of Placebo 100 mg once daily during 3 days of treatment period
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once daily during 3 days.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
大体时间：From the time of randomization up to Day 14
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The time before the onset of sustained improvement in clinical symptoms according to the Modified Jackson Scale (no more than 1 point for each symptom), measured in hours from the moment of the first dose of the drug. Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms. Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe). Total score (ranges from 0 to 32 points) is a sum of the point for each symptom. |
From the time of randomization up to Day 14
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Body Temperature Normalization
大体时间：From the time of randomization assessed up to Day 14
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Time to body temperature normalization since treatment initiation, measured in hours (normalization is regarded as setting of body temperature below 37°C without elevation above these values)
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From the time of randomization assessed up to Day 14
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Percentage of Patients With Complications
大体时间：From the time of randomization up to Day 14
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The percentage of patients with complications of influenza/acute viral URI
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From the time of randomization up to Day 14
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The Area Under the Curve "Modified Jackson Scale Score" During 3-day Therapy
大体时间：From randomization up to 3 days of treatment
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Modified Jackson Scale measures individuals' subjective ratings the severity of 12 respiratory symptoms.
Ranges for each symptom: 0 points (no symptoms) - 3 points (the most severe).
Total score (ranges from 0 to 32 points) is a sum of the point for each symptom.
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From randomization up to 3 days of treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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XC221 100 mg的临床试验
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Valenta Pharm JSC完全的
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PHARMENTERPRISES LLCRSV Therapeutics LLC完全的