CTRI/2021/03/032446招募中2/3 期
An Open-label, Randomized, Three Arm, comparative, standard control Clinical Study to evaluate the safety and efficacy of HAVR-122008 in the Treatment of uncomplicated respiratory viral infection.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Improvement in clinical symptoms (based on 0 -10 Numeric rating scale).
研究概览
简要总结
Subject will be screened on the basis of apparent clinical symptoms of respiratory viral infection. Once the subject is eligible for the study, the subject will be randomized either of the treatment arms i.e, Arm I & Arm II in 1:1 ratio. Subjects randomized to Arm 1 will receive standard of care treatment. Subjects randomized to Arm 2 will receive Investigational product (Anti-Viral capsule).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects of either gender aged more than >18 – <65 years.
- •2.Subjects suffering from acute respiratory illness with one or more signs and symptoms consistent with a viral infection (eg.
- •fever, headache, nasal discharge, fatigue, sore throat, sneezing, cough, sleep disturbance, muscle or body aches etc) 3.Onset of symptoms within 3 days from the anticipated time of randomization.
- •Onset of symptoms is defined as the time the subject becomes aware of the first sign and/or symptom consistent with a viral infection.
- •4.Subject must be medically stable on the basis of physical examination, medical history and vital signs performed at screening.
- •5.Ability to understand and willing to give a written informed consent prior to any study-related procedures and ready to follow and in agreement to visits as per the study assessment visits 6.Women of child-bearing potential and men with partners of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 15 days following completion of therapy.
排除标准
- •1.Subjects with opportunistic infections / severe infections requiring of Anti-viral / Anti-Bacterial medication at screening.
- •Hospitalized subjects or subjects expected to be hospitalized during the study duration.
- •3.Individuals with acute respiratory distress.
- •4.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/renal/liver diseases 5.Subjects with known hypersensitivity to any of the test materials or related compounds.
- •Subjects who had major surgery within the 28 days prior to randomization or have planned major surgery through the course of the study
- •Subject with a history of known or suspected chronic or acute hepatitis B or C infection 8.Women who are pregnant or breastfeeding 9.Pre-existing systemic disease necessitating long-term medications.
- •10.Genetic and endocrinal disorders.
结局指标
主要结局
Improvement in clinical symptoms (based on 0 -10 Numeric rating scale).
时间窗: 7 -10 days
Time taken in resolution of clinical symptoms.
时间窗: 7 -10 days
Decrease in viral load from baseline visit to end of study.
时间窗: 7 -10 days
Number of people having secondary infection / complications.
时间窗: 7 -10 days
次要结局
- any incidence of drug related adverse events.(7 - 10 days)
研究者
研究点 (3)
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