A Post Approval for Restricted Use Under Emergency Situation Study to Evaluate the Efficacy and Safety of DESREMTM in Patients with Moderate to Severe Covid-19 in Indian Population.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 11
- 主要终点
- Mortality rate
研究概览
简要总结
This will be a postapproval for restricted use under emergency situation study,interventional, prospective, multi-center, open-label study to evaluate the safetyand efficacy of DESREMTM in Indian patients with moderate tosevere Covid-19 disease.
Primary objective:
To determine the efficacy of DESREMTMin patients with moderate to severe Covid-19, assessed by two-pointimprovement from baseline in clinical status on the 8-point ordinal scale atDay 14.
To determine the mortality rate in patientswith moderate to severe Covid-19 at Day 28 treated with DESREMTM
Secondaryobjective:
Keysecondary Objective: To assess the safety and tolerability of DESREMTMin patients with moderate to severe Covid-19.
Other secondary objectives: To assess efficacyof DESREMTM in patients with moderate to severe Covid-19, by viralclearance, fever normalization and time toSpO2 ≥ 94% on room air.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 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
- •Admitted to a hospital and has confirmed Covid-19 infection (Moderate to Severe
- •Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures, understand and agrees to comply with planned study procedures
- •Male and non-pregnant female subjects aged 18 years and above
- •Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen, as documented by either or the following: -PCR positive in sample collected < 72 hours prior to enrollment; OR -PCR positive in sample collected ≥ 72 hours prior to enrollment, documented inability to obtain a repeat sample
- •Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare Directorate General of Health Services) Clinical Management Protocol COVID 19(Dated 03 Jul 2020): Clinical severity of moderate to severe.
- •Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 28
- •Agrees to not participate in another clinical trial for the treatment of COVID-19 or any other indications through Day 28.
排除标准
- •1.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 3 times the upper limit of normal.
- •2.Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
- •3.Pregnancy or breast feeding 4.Subjects with <40 kg body weight 5.Subjects who are on mechanical ventilation or ECMO (Extracorporeal membrane oxygenation) 6.Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours 7.Hypersensitivity to any ingredient of DESREMTM 8.Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment 9.Patients who are on or would require any other investigational therapies/products for the treatment of Covid-19 disease.
结局指标
主要结局
Mortality rate
时间窗: Day 14 | Day 28
Percentage of patients with at least two-point improvement from baseline in clinical status on the 8-point Ordinal scale
时间窗: Day 14 | Day 28
次要结局
- Time to Recovery(Day 14)
- Proportion of patients with viral clearance (SARS CoV-2 negativity)(Day 7, Day 14/ Time of Discharge)
- Time to first fever normalization(Day 14 & Day 28)
- Incidence of Treatment Emergent AEs(Day 1 to Day 28)
- Time to SpO2 94 % on room air(Day 14 & Day 28)
- Mean Change from Baseline(Assessment day upto Day 28)