The Use of Desferal and Adjuvants for Prevention of ARDS in Hospitalised Cases Documented With Covid 19 Infection: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Mortality rate
研究概览
简要总结
To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images
详细描述
COVID-19 is a condition caused by a coronavirus (called SARS-CoV-2) that was first identified in late 2019. In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. Recent theory showed that the severe respiratory manifestations could be due to iron toxicity which cause intense inflammation in the alveoli and hence the ground glass appearance that was seen in ragdiology imaging
Objective :
To evaluate the efficacy of using Desferal injections for prevention of ARDS in moderate cases with fever , chest tightness and relevant chest images
Randomisation:
Participants are randomly allocated to either standard care or standard care plus Desferal injection. Randomization will be done through computer generated list by principal investigator. Allocation will be determined by block randomisation, stratified by hospital. This will be carried out by an independent statistician, prior to the trial commencement, using Stata (StataCorp, College Station, TX, USA) to generate the allocation sequence. Allocations will be concealed within sequentially numbered, sealed opaque envelopes, prepared by two research assistants who are independent of the trial Blinding This study will be single blind. Doctors will not be blinded to intervention allocation due to lack of feasibility
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Placebo group Will receive glucose 5% over 4 hrs infusion
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients positive for Covid 19 admitted to hospital with chest tightness
排除标准
- •Pregnancy
- •Breastfeeding
- •Known severe hepatic impairment
- •Known severe renal impairment
- •Known porphyrias
- •Diabetes mellitus
- •Known G6PD deficiency
- •Known myasthenia gravis
- •Known severe psoriasis
- •Known severe neurological disorders (especially those with a history of epilepsy - may lower seizure threshold)
研究组 & 干预措施
Desferal
An initial dose of 1000 mg should be administered at a rate NOT TO EXCEED 15 mg/kg/hr. This may be followed by 500 mg over 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered over 4-12 hours
干预措施: Desferal 500 MG Injection (Drug)
control group
Will receive glucose 5% over 4 hrs infusion
干预措施: Desferal 500 MG Injection (Drug)
结局指标
主要结局
Mortality rate
时间窗: two weeks
patient dies from ARDS
次要结局
- Duration of severe symptoms(two weeks)
研究者
Hesham Al-Inany
Prof
Cairo University