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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
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-
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Izhevsk、ロシア連邦、426063
- City Clinical Hospital №9
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Krasnodar、ロシア連邦、350063
- Kuban State Medical University
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Rostov-on-Don、ロシア連邦、344000
- City Clinical Hospital №1 n.a. Semashko
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Ryazan'、ロシア連邦、390026
- Ryazan State Medical University n.a. Pavlov
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Saint Petersburg、ロシア連邦、190103
- The Center for Prevention and Fight about AIDS and Infectious Diseases
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Saint Petersburg、ロシア連邦、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、ロシア連邦、197376
- Research Institute of Influenza
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Saint Petersburg、ロシア連邦、197706
- City Clinical Hospital №40 of Kurortny District
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Saransk、ロシア連邦、430024
- Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
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Volgograd、ロシア連邦、400131
- Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
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Yaroslavl、ロシア連邦、150007
- Сlinical Hospital №3
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：XC221 200 mg
XC221 200 mg orally. 2 tablets of XC221 100 mg once daily during 3 days of treatment period
|
once daily during 3 days.
|
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プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
時間枠：From the time of randomization up to Day 14
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Body Temperature Normalization
時間枠：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
時間枠：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
時間枠：From randomization up to 3 days of treatment
|
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 randomization up to 3 days of treatment
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ARI-XC221-02
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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XC221 100 mgの臨床試験
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