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临床试验/NCT05311813
NCT05311813已完成不适用

Evaluation of Safety and Efficacy of Monotherapy Versus Polytherapy of Enoxaparin and Hydroxychloroquine for the Treatment of Covid-19

Beni-Suef University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Assessment of efficacy

研究概览

简要总结

In this randomized controlled study, two hundred patients with positive PCR and laboratory confirmed COVID-19 will be classified randomly into four groups. The first group is the control group and will be given the conventional treatment of covid-19 only. The second group will be given enoxaparin plus the conventional treatment of Covid-19. The third group will be given hydroxychloroquine (HCQ 400 mg/day) for five days plus the conventional treatment of covid-19. The last group will be given combined therapy of HCQ 400 mg/day and enoxaparin plus the conventional therapy of covid-19

The efficacy will be assessed by the time of undetectable viral RNA, duration of treatment and length of hospital stay. The safety will be assessed by measuring the severity of side effects by following up the patients after treatment.

详细描述

Although numerous therapeutic agents for COVID-19 are under investigation, an effective therapy remains a challenge among researchers. To date, hydroxychloroquine has been widely used for covid-19 treatment, despite that its efficacy and safety need further investigations. Coagulopathies are major complications of covid-19 infection, hence prophylactic anticoagulation has been recommended in all hospitalized patients. This study aims to assess the efficacy and safety of Enoxaparin and hydroxychloroquine used separately or combined and added to standard care versus standard care alone in Covid-19 infected patients. An observational study including two hundred patients (98 males, 102 females) with laboratory confirmed covid-19 infection was conducted. Patients admitted to hospital were randomly allocated into four equal treatment groups. The first group received standard Covid-19 therapy, second group received enoxaparin 40mg/day SC for 14 days plus standard Covid-19 therapy, third group received 400 mg/day HCQ for five days plus standard Covid-19 therapy. The fourth group received a combination of 400 mg/day HCQ and enoxaparin plus standard Covid-19 therapy. The clinical disease course progression was evaluated by duration to a negative PCR, length of hospital or ICU stay, and mortality rate. The safety of treatments was evaluated by measuring liver biochemistries (ALT, AST), random blood glucose levels and adverse effects during the 28 days of treatment. Patients on Enoxaparin plus standard Covid-19 therapy significantly showed a decrease in length of hospital stay, ICU admission and mortality compared to all other treatments. However, the duration to both negative PCR and clinical improvement did not find any significance. These findings suggest that enoxaparin treatment was safe, effective, and well tolerated and has a role in decreasing the progression of the disease and its complications while HCQ did not discover any evidence of extra therapeutic benefits over other treatments.

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Laboratory confirmed COVID-19 infection by PCR test within 7 days prior to admission or during admission to hospital, CT or radiographic findings of pneumonia. Clinically suspected infection by symptoms like loss of smell and taste. No medical history that may interfere with treatment or with this clinical trial.

排除标准

  • Patient who had allergy or contraindication to HCQ, pregnant and lactating females, and patients with immune diseases, cardiac problem, had history of acute kidney injury or who received multiple cycles of anticoagulants were excluded from the study. Written informed consent was obtained from each participant. All study risks and benefits were thoroughly explained to patients' prior participation

研究组 & 干预措施

Control group

Placebo Comparator

The control group including 50 patients (n=50) receiving the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days.

干预措施: Enoxaparin, Hydroxychloroquine (Drug)

Enaxoprin group

Active Comparator

The enoxaparin group (n=50) which received 40mg/day SC for 14 days (for patients with normal renal function and body weight between 50 and 100kg) plus the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days.

干预措施: Enoxaparin, Hydroxychloroquine (Drug)

Hydroxychloroquine group

Active Comparator

The HCQ group which received 400 mg/day HCQ for five days plus the conventional therapy of Covid-19 adopted by the Egyptian ministry of health for 15 days(n=50).

干预措施: Enoxaparin, Hydroxychloroquine (Drug)

Enoxaparin plus Hydroxychloroquine group

Active Comparator

The HCQ plus Enoxaparin combination group including 50 patients receiving combined therapy of 400 mg/day HCQ for five days and 40mg/day enoxaparin for 14 days plus the conventional therapy of COVID-19 adopted by the Egyptian ministry of health for 15 days

干预措施: Enoxaparin, Hydroxychloroquine (Drug)

结局指标

主要结局

Assessment of efficacy

时间窗: 6 monthes

The hospital stay of COVID-19 patients

次要结局

  • Assessment of Safety(6 monthes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raghda R.S. Hussein

Assistant Professor of Clinical Pharmacy

Beni-Suef University

研究点 (1)

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