CTRI/2021/04/032804已完成3 期
A Randomized, Placebo controlled, double blinded, parallel group clinical study to evaluate the efficacy and safety of AEV01 (Kutki) for Mild COVID19 in Elderly patients at risk of complications.
PM Medical Centre3 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月18日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 3
- 主要终点
- 3.Spo2 rate greater than 94%
研究概览
简要总结
| The selected 70 Participants will be randomized into 2 groups with 35 in each group. Placebo Group patients diagnosed as mild SARS-CoV-2 infection will receive Placebo + standard of care treatment(as per hospital regulation) as per the WHO/ICMR guidelines and Test Group patients diagnosed as mild SARS-CoV-2 infection will receiveAEV01+ standard of care treatment (as per hospital regulation) as per the WHO/ICMR guidelines. The primary outcome measures will be to assess the efficacy of the drug as follows; Time for clinical improvement [Time Frame: up to Day 30], which is defined as; 1. Normalization of pyrexia and body pain 2. Respiratory rate less than 24/minute 3.Spo2 rate greater than 94% 4. Relief from cough and maintenance of above for more than 72 hours. The secondary outcome measure will be ; 1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale. 2. Change from baseline in various lab parameters. The results of the Placebo and treatment arm will be analyzed and compared. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Willing and able to provide written informed consent prior to performing study procedures.
- •Adult patients aged more than 50 years with SARS-CoV-2 infection and mild disease.
- •Patients with Mild (uncomplicated) Illness is defined as – a.Diagnosed with COVID-19 by a standardized RT-PCR assay AND b.Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND c.No signs of a more serious lower airway disease AND d.RR<20, HR <90, oxygen saturation (pulse oximetry) > 94% on room air.
排除标准
- •Participants with moderate and severe illness of COVID
- •Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) 3.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR< 30) 4.Immuno-compromised patients on medications.
- •5.Participation in any other clinical trial of an experimental treatment for COVID-19
- •Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment.
结局指标
主要结局
3.Spo2 rate greater than 94%
时间窗: Day 1 to Day 30
Time for clinical improvement , which is defined as;
时间窗: Day 1 to Day 30
1. Normalization of pyrexia and body pain
时间窗: Day 1 to Day 30
2. Respiratory rate less than 24/minute
时间窗: Day 1 to Day 30
4. Relief from cough and maintenance of above for more than 72 hours.
时间窗: Day 1 to Day 30
次要结局
- 1. Percentage of subjects reporting each severity rating on a 8-point ordinal scale.(2. Change from baseline in the following lab parameters namely, CBC, ESR, RBS, CRP, LFT, RFT, Serum electrolytes, serum ferritin, D-dimer, CD4, CD8, TNF-ï¡, IL-6, Covid-19 IgM & IgG and HRLCT scan.)
研究者
研究点 (3)
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