Ivermectin Reproposing for COVID-19 Treatment in Outpatients With Mild Stage
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Proportion test
研究概览
简要总结
Background:
The emergency of COVID-19, along with the current difficulties in responding to the high demand for vaccines, requests to the scientific community to find alternative treatments based on reuse of drugs as a strategy to prevent the progression of the disease in patients infected with SARS COV 2.
Objetive This study aims to evaluate the use of ivermectin in mild-stage patients to increase outpatient discharge and prevent the progression to moderate or severe stages of the disease.
Added value of this study We found that an intervention with ivermectin has impacted on the PPS in a population of outpatients care, between the 5th and 9th day. Also, the treatment increased the probability to obtain outpatient discharge, even in the presence of comorbidities.
Implications of all available evidence.
Research in Context According to the COVID-19 Treatment Guidelines by the NIH, most trials have several limitations. It needs results from adequately powered and well-designed clinical trials to provide evidence-based guidance on the role of ivermectin in the treatment of COVID- 19. However, our study shows overlaps in benefits with other authors, and taking together, these results are encouraging for further study about repurposing ivermectin for the treatment of COVID-19.
详细描述
Technical Design:
Cluster Randomised Trials in outpatients care, n = 254. The subjects were divided into experimental (EG: n = 110) and control groups (CG: n = 144). The criteria for this choice were based on the geographical distribution of Health Services, locomotion, and logistics in current times of pandemic.
Sample Size:
Sample size was determined by the test comparing two proportions. It considered the following parameters to the bilateral test: n = 30,000 Total operating area population for services network to Primary Care; 95% confidence level, 3% precision, 5% proportion, n = 201 sample size without loss, 20% expected proportion of losses. The sample size calculated was n= 252 participants.
Participants:
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
盲法说明
Each of the health centers (cluster of health centers) was randomly assigned to receive or not the intervention under study. The conglomerate of outpatients randomly assigned to the Experimental Group (EG) and Control Group (CG) belongs to the urban and peri-urban areas from Tucumán, and the selection of the centers was carried out considering a homogeneous socioeconomic profile in relation to the operating areas in which it is organized the Public Health Systems. Participants were recruited prior to cluster randomisation. Staff of each assistance center knew what intervention was being implemented as well as patients. Data processing group was blind to analyze the database.
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
- 否
入选标准
- •Outpatients infected by SARSCoV-2 confirmed either by RT-PCR test, Neo Kit or rapid test authorized by ANMAT or by close contact or epidemiological link;
- •Women of childbearing age with a negative pregnancy test;
- •Mild disease-patients with two or more of the following symptoms: fever less than 38·5°C and higher than 37.5°C according to Ministry of Health, Argentina(16), isolated diarrheal episodes, hyposmia or hypogeusia, mild desaturation (between 96 and 93%), dyspnea, polyarthralgia, persistent headache, abdominal pain, erythema of the kidney, nonspecific rash.
排除标准
- •Hypersensitivity or allergy to Ivermectin;
- •Pregnant or lactating;
- •Children or adolescents under 18 years of age;
- •Patients with Neurological Pathology, Renal Insufficiency, Hepatic Insufficiency;
- •Weight less than 40kg;
- •Patients with concomitant use of drugs that act on GABA, barbiturate and benzodiazepine receptors;
- •Patients who have not completed / signed the informed consent.
研究组 & 干预措施
Experimental Group
The EG received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.
All participants were evaluated by physical examination COVID-19 diagnosed with positive RT-PCR at the beginning, and final of the protocol
干预措施: Ivermectin (Drug)
结局指标
主要结局
Proportion test
时间窗: from 10th to 14th day.
Proportion of patientts with symptoms (fever, diarrhea, taste and/or smell disturbance, SpO2, polyarthralgia, headache, body pain, abdominal pain, ALRI symptoms and signs)
次要结局
- Odd Ratio(28 days after enrollment)
- Odd Ratio and logistic regression test(28 days after enrollment)
研究者
Maria de los Angeles Peral de Bruno
Director of Research - Ministry of Health of Tucumán
Ministry of Public Health, Argentina