An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid 19 caused by SARS-CoV2 (B-CoV).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- 1.Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalgia, malaise from baseline.
研究概览
简要总结
StudyDesign : An Open Label, Prospective, Randomised, Comparative, TwoArm Clinical Study Investigational Product : Nichi Glucan Comparator : None. Conventional Therapy only to be provdied. Indication : Covid19 caused by SARS-COV2 (beta COV) Subject Population : Adult Subjects aged between 18 and 65 years ( bothages all sexes inclusive) who are confirmed to be positive for SARS-COV2 by wayof RT-PCR in a laboratory approved by MoH-FW and the State Government Number of Subjects : 48 Subjects Treatment Arms : Two Treatment Arm I : Nichi Glucan + Conventional Therapy : 24 Subjects Treatment Arm II : Conventional Therapy : 24 Subjects Treatment Duration : Maximum of 30 days per enrolled Subject Assessments 1. Covid19 Clinical Symptoms : Day 1, Day 15, Day 30 2. RT PCR : Day 1, Day 15, Day 30 3. Immunological Parameters : Day 1, Day 15, Day 30 4. Hospitalisation Parameters : Day 1, Day 15, Day 30 5. Blood Parameters : Day 1, Day 15, Day 30 6. Chest Scan : Day 1, Day 15, Day 30 7. Quality of Life Questionnaire : Day 15, Day 30
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
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.Adult subjects between 18 and 65 years (both ages and sexes inclusive) who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government.
- •2.Subjects with co-morbidities can be included.
- •To be analysed as cohort.
- •3.Subjects who are found to be Covid19 positive requiring hospitalization.
- •(symptomatic or asymptomatic) 4.Subject and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
- •5.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects who have previously been infected with SARS-CoV2 (symptomatic or asymptomatic) and recovered.
- •2.Subjects who are known to be HIV, HBV, HCV positive.
- •3.Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study.
- •4.Subjects with complete cancer remission less than 3 years prior to the date of screening.
- •5.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
- •6.Subjects who are on anti-depressants, anti-psychotics.
- •7.Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication.
- •8.Females who are pregnant or nursing or planning to become pregnant during the study period.
结局指标
主要结局
1.Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalgia, malaise from baseline.
时间窗: Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 | RT PCR: Day 1, Day 15, Day 30
2.RT PCR: Time taken for negative RT PCR Result from baseline.
时间窗: Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 | RT PCR: Day 1, Day 15, Day 30
3.RT PCR : Reduction of titer/severity level from baseline.
时间窗: Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 | RT PCR: Day 1, Day 15, Day 30
次要结局
- Immunology : CD4, CD8, CD56, CD13, IgA, IL6(Hospitalisation : Mortality, ICU admission, Oxygen/LifeSupport)