CTRI/2021/12/038637进行中（未招募）4 期
A post approval for restricted use under emergency situation study to evaluate the Safety and Efficacy of DESREM LQTM in patients with Moderate to Severe Covid-19 in Indian population.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 13
- 主要终点
- Incidence of treatment emergent AEs and SAEs
研究概览
简要总结
This will be a post approval for restricted use under emergency situation study, interventional, prospective, multi-center, open-label study to evaluate the safety and efficacy of DESREM LQTM in Indian patients with moderate to severe Covid-19 disease.
Primary objective is to assess the Safety and Tolerability of DESREM LQ TMin patients with moderate to severe Covid 19, by determining incidence of Adverse events during
DESREM LQ TM treatment and upto Day 28 from enrollment.
Secondary objective is to determine mortality at day 28
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 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed Covid-19 infection
- •Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures
- •Subject (or legally authorized representative) understands and agrees to comply with planned study procedures
- •Male or non-pregnant female adult ≥ 18 years of age at time of enrollment
- •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 (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) AND progressive disease suggestive of ongoing SARS-CoV-2 infection
- •Illness of any duration, and at least one of the following: Meeting the updated MoHFW (Ministry of Health and Family welfare, Government of India) Clinical Guidance For Management of Adult COVID-19 Patients (Dated 22 Apr 2021): 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
- •Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 3 times the upper limit of normal
- •Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration)
- •Pregnancy or breast feeding
- •Subjects with <40 kg body weight
- •Subjects who are on mechanical ventilation or ECMO (Extracorporeal membrane oxygenation)
- •Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours
- •Hypersensitivity to any ingredient of DESREM LQTM
- •Any other condition as per the physician’s discretion which would make the patient unsuitable for enrollment in the study
- •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
Incidence of treatment emergent AEs and SAEs
时间窗: Day 1 to Day 28
次要结局
- Mortality(Percentage of patients with atleast Two point improvement from baseline in clinical status on the 8 Point ordinal scale)
研究者
研究点 (13)
Loading locations...
相似试验
尚未招募
4 期
A Clinical Trial to study the safety and efficacy of a drug, DESREM TM in patients with Moderate to Severe Covid-19.Coronavirus as the cause of diseases classified elsewhere,CTRI/2022/02/040649Mylan Laboratories Limited130
No Longer Available
不适用
Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver CancerCarcinoma, HepatocellularNeoplasm MetastasisNCT00701168Leo W. Jenkins Cancer Center
已完成
不适用
Feasibility of Community Psychosocial Intervention for WomenPsychological DistressCoping SkillsMental Health Wellness 1StressNCT05130944Columbia University275
Enrolling By Invitation
不适用
Examining the Effectiveness and Implementation of the Emergency Department Patient-Activated Transition to Care At Home ToolEmergency Department Discharge CommunicationNCT06668636IWK Health Centre12,000
已完成
不适用
Clinical Study to Prove Safety in Use (Irritability and Sensitization in Genital Mucosa) of an Intimate Lubricating GelFemale Dry Genital MucosaNCT02441647Kley Hertz S/A33