CTRI/2020/05/025483已完成Phase 3 4
A Randomized, Multicentric, Open label, Parallel group Clinical study to Evaluate the EFFICACY and SAFETY of CLEVIRA in mild to moderate COVID19 POSITIVE Patients
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- a.Time taken for clinical recovery, which is defined as;
研究概览
简要总结
| A total of 100 patients confirmed with COVID19 infection(mil to moderate cases) by RT-PCR will be included in the study. The selection of the patients will be based on initial screening and study criteria. Participants will be randomized into 2 groups with 50 patients in each group. |
- Group 1(Control arm) – Patients diagnosed as SARS-CoV-2 infection will receive standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines.All key co-interventions will be documented.
- Group 2(Treatment arm)- Patients diagnosed as SARS-CoV-2 infection will receive standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines. In addition tablet CLEVIRA will be given twice daily for 14 days.
- The mentioned Primary & secondary outcomes will be assessed.
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 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent prior to performing study procedures.
- •Males and females between the age of 18-50 years.
- •Mild to moderate COVID-19 associated disease as defined by the WHO.
- •Hospitalized patient.
- •6.Illness of any duration and febrile/afebrile.
- •Febrile-defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal documented within 48 hours of consent.
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-19 2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation 3.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) 4.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) 5.Pregnant women or women who are breastfeeding 6.Immunocompromised patients taking medication upon screening 7.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment.
结局指标
主要结局
a.Time taken for clinical recovery, which is defined as;
时间窗: At day 5, day 10 and day 15
1. Normalization of pyrexia and body pain
时间窗: At day 5, day 10 and day 15
3.Spo2 rate greater than 94%
时间窗: At day 5, day 10 and day 15
2. Respiratory rate less than 24/minute
时间窗: At day 5, day 10 and day 15
b.Proportion of patients with swabs negative for COVID19 in RT PCR at day 5, 10 and 15
时间窗: At day 5, day 10 and day 15
c.Reduction of Viral Load.
时间窗: At day 5, day 10 and day 15
4. Relief from cough and maintenance of above for more than 72 hours.
时间窗: At day 5, day 10 and day 15
次要结局
- a.Clinical status of subject (on a 6 point ordinal scale).(1.Discharged having reached clinical recovery criteria)
研究者
研究点 (1)
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