Pilot Study to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Proportion of Patients With a Positive SARS-CoV-2 PCR
研究概览
简要总结
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
详细描述
SAINT is a double-blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing nasal viral carriage at seven days after treatment in SARS-CoV-2 infected patients who are at low risk of progression to severe disease. The trial is currently planned at a single center in Navarra.
Participants will be randomized to receive a single dose of 400 mcg/kg ivermectin or a placebo. The randomization code will be generated by the trial statistician using blocks that ensure balance between the groups.
The allocation will be made by the investigator after obtaining informed consent, and confirmation of fulfillment of all inclusion and none of the exclusion criteria. The investigational product will be administered by a researcher not involved in patient care or participant follow up.
Participants will remain in the trial for a period of 28 days.
In the interests of public health and containing transmission of infection, trial visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members.
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
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.
- •Residents of the Pamplona basin ("Cuenca de Pamplona")
- •The patient should be aged 18 to 59 years
- •Negative pregnancy test for women of child bearing age*
- •The patient or his/her representative, have given consent to participate in the study.
- •The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)
- •Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study)
排除标准
- •Known history of Ivermectin allergy
- •Hypersensitivity to any component of Stromectol®
- •COVID-19 Pneumonia
- •Diagnosed by the attending physician
- •Identified in a chest X-ray
- •Fever or cough present for more than 48 hours
- •Positive IgG against SARS-CoV-2 by rapid test
- •Age under 18 or over 60 years
- •The following co-morbidities (or any other disease that might interfere with the study in the eyes of the investigator):
- •Immunosuppression
- •Chronic Obstructive Pulmonary Disease
- •Hypertension
- •Acute or chronic renal failure
- •History of coronary disease
- •History of cerebrovascular disease
- •Current neoplasm
- •Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)
- •Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.
研究组 & 干预措施
Ivermectin
Participants on this arm will receive a single, oral dose of ivermectin 400 mcg/kg at the enrolment visit.
干预措施: Ivermectin (Drug)
Placebo
Participants on the arm will receive a single, oral dose of placebo tablets at the enrollment visit.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Patients With a Positive SARS-CoV-2 PCR
时间窗: 7 days post-treatment
Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. PCRs were performed using two target genes (E and N).
次要结局
- Results From Cytokine Human Magnetic 30-Plex Panel(Up to and including day 28)
- Seroconversion at Day 21(Up to and including day 21)
- Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T Cells(Up to and including day 7)
- Fever and Cough Progression(Days 4, 7, 14 and 21)
- Median Viral Load(Baseline and on days 4, 7, 14 and 21)
- Frequency of Innate Immune Cells(Up to and including day 7)
- Proportion of Drug-related Adverse Events(7 days post treatment)
- Levels of IgG, IgM and IgA(Up to and including day 28)