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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Izhevsk, 러시아 연방, 426063
- City Clinical Hospital №9
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Krasnodar, 러시아 연방, 350063
- Kuban State Medical University
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Rostov-on-Don, 러시아 연방, 344000
- City Clinical Hospital №1 n.a. Semashko
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Ryazan', 러시아 연방, 390026
- Ryazan State Medical University n.a. Pavlov
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Saint Petersburg, 러시아 연방, 190103
- The Center for Prevention and Fight about AIDS and Infectious Diseases
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Saint Petersburg, 러시아 연방, 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, 러시아 연방, 197376
- Research Institute of Influenza
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Saint Petersburg, 러시아 연방, 197706
- City Clinical Hospital №40 of Kurortny District
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Saransk, 러시아 연방, 430024
- Mordovia State Medical University n.a. N.P.Ogarev, Clinical site - Republic Infectious Clinical Hospital
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Volgograd, 러시아 연방, 400131
- Volgograd State Medical University, Clinical site - Infectious Regional Clinical Hospital № 1
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Yaroslavl, 러시아 연방, 150007
- Сlinical Hospital №3
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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실험적: 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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위약 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Sustained Improvement in Clinical Symptoms Based on Modified Jackson Scale for ARVI
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Body Temperature Normalization
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ARI-XC221-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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XC221 100 mg에 대한 임상 시험
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Valenta Pharm JSC완전한
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Valenta Pharm JSC완전한인플루엔자 | 바이러스성 호흡기 감염 | 급성 바이러스성 상부 호흡기 감염러시아 연방
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PHARMENTERPRISES LLCRSV Therapeutics LLC완전한
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Biomea Fusion Inc.모병