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临床试验/NCT04891250
NCT04891250撤回4 期

The Zambia Ivermectin Trial for the Treatment and Prevention of COVID-19

Centre for Infectious Disease Research in Zambia1 个研究点 分布在 1 个国家开始时间: 2021年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
All-cause COVID-19 related mortality

研究概览

简要总结

The study aims to test whether Ivermectin would decrease mortality and reduces chances of getting infected with corona virus, improve management of clinical symptoms and reduce length of stay in ICU and transition probabilities to ICU (ventilator).

详细描述

With the onset of global pandemic of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) and the sharp rise in infection and mortality rates, efficient management of the current medical emergency has become an absolute priority. A lot of resources have been directed to developing a comprehensive therapeutic approach to preventing and curing this disease, and this has mostly been in western countries. However, lack of definite treatment, high number of infected people, limited capacity and the impact of COVID-19 on existing health infrastructure has left biomedical researchers and clinicians faced with the mammoth task of providing appropriate clinical care solutions and strategies with favorable cost-benefit outcomes, which can help in both curbing the disease and treating patients. To meet this challenge, repurposing of available drugs has become vital. Evidence from several recent clinical trials on the effects of available therapeutic clinical drugs and vitamin supplements on mortality rate and other clinical outcomes associated with COVID-19 are promising, however, the efficacy, safety, and appropriate dosing of therapeutic clinical drugs such as ivermectin, remain largely unevaluated in Sub-Saharan Africa. The investigators propose to evaluate and compare the efficacy of ivermectin in the management of Covid-19.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals diagnosed positive for SARS-CoV-2 by real-time reverse transcription PCR (rRT-PCR with presence of a fever, cough, and/or sore throat.

排除标准

  • Patients will be excluded if they report to be allergic to ivermectin or if there is potential for a drug-drug interaction with ivermectin;
  • Have chronic illnesses (e.g., ischemic heart disease, heart failure, documented cardiomyopathy, chronic kidney disease, chronic liver disease);
  • Have received ivermectin in the last 7 days; are pregnant or lactating;
  • Or have participated in any other clinical trial within the last month.

研究组 & 干预措施

Intervention

Experimental

Patients with moderate to severe COVID-19 disease will be randomized to either Ivermectin (Intervention) or Standard of Care (Control arm) in a 1:1 ratio

干预措施: Ivermectin (Drug)

Prophylaxis

Experimental

An additional group of patients will be recruited will be randomized to either Ivermectin as prophylaxis (Intervention) or Standard of Care with no ivermectin (Control arm) in a 1:1 ratio

干预措施: Prophylaxis (Other)

结局指标

主要结局

All-cause COVID-19 related mortality

时间窗: within 28 days of enrollment

All-cause COVID-19 related mortality

COVID-19 Infection

时间窗: Study duration

the proportion of patients on Ivermectin prophylaxis who test positive for COVID 19 using PCR after initially testing negative at enrolment

次要结局

  • Patient cure rate(14- 28 days)
  • Participant Infection Rate(90 days)

研究者

发起方
Centre for Infectious Disease Research in Zambia
申办方类型
Other
责任方
Sponsor

研究点 (1)

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