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临床试验/NCT04753619
NCT04753619Unknown2 期

Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)

University of Baghdad1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
150
试验地点
1
主要终点
Time to recovery

研究概览

简要总结

Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial

详细描述

Protocol of therapy Niclosamaide Add on group

  • NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days]
  • If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.

Control group The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient:

  • Acetaminophen 500mg on need
  • Vitamin C 1000mg twice/ day
  • Zinc 75-125 mg/day
  • Vitamin D3 5000IU/day
  • Azithromycin 250mg/day for 5 days
  • Oxygen therapy/ C-Pap if needed
  • Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
  • Mechanical ventilation, if needed

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with age above 18 years and of any gender.
  • Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18).
  • Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases.
  • Understands and agrees to comply with planned study procedures.

排除标准

  • Patients refuse to enrol in the study
  • Patients with hypersensitivity or severe adverse effects to niclosamide
  • Renal impairment
  • Hepatic impairment
  • Pregnancy or a desire to become pregnant
  • Breast feeding

研究组 & 干预措施

Niclosamide group: NCS group

Experimental

NCL + standard therapy

干预措施: Niclosamide Oral Tablet (Drug)

结局指标

主要结局

Time to recovery

时间窗: 7 days

- to study the time to recovery ( stay days in hospital)

Percentage of Cure of the patient

时间窗: 7 days

To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging.

次要结局

  • The percentage of Progressive patients(7 days)
  • Rate of mortality(7 days)
  • Side effects(7 days)

研究者

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

Faiq Gorial

Professor

University of Baghdad

研究点 (1)

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