Randomized Phase IIA Clinical Trial to Evaluate the Efficacy of Ivermectin to Obtain Negative PCR Results in Patients With Early Phase COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 186
- 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-PERU is a triple-blinded, randomized placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.
详细描述
SAINT is a triple-blinded, randomized placebo-controlled trial with two parallel arms to evaluate the efficacy of ivermectin in negativizing nasopharyngeal PCR in patients with SARS-CoV-2 infection. The trial is conducted in two national hospitals at Lima-Peru.
The planned sample size is 186 SARS-CoV-2 PCR positive patients: 93 patients to treatment and 93 to the placebo group. Participants will be randomized to receive one dose of 300 mcg/kg ivermectin or placebo daily for three consecutive days. The epidemiologist will generate a list of correlative numbers, in randomized blocks of size 4, with the assignment to the treatment groups (a and b). The randomization list will be kept in an encrypted file accessible only to the trial statistician. This list will be handed directly to the pharmacist. Independently, the principal investigator will randomly assign the intervention (ivermectin) to one of the two groups (a or b) by tossing a coin, and will inform the pharmacist of the result of this process. The pharmacist will prepare and label the treatment vials according to the randomization list prepared by the epidemiologist and the treatment assignment given by the principal investigator. Eligible patients will be allocated in a 1:1 ratio using this randomization list.
Participants are expected to remain in the trial for a period of 21 days.
In the interests of public health and containing transmission of infection, follow-up visits will be conducted by the trial medical staff at the participant's home or at a hospital in case of hospitalization.
Follow-up visits will assess clinical and laboratory parameters of the patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The Ivermectin presentation will be an oral drop solution in a flasks containing 5ml. The placebo presentation will also be an oral drop solution, undistinguishable from ivermectin, but without this device pharmaceutical ingredient. The pharmacist will prepare the treatment flasks (three 5ml flasks per participant), labelling them according to the randomization list in blocks of four (a, b) previously prepared by the epidemiologist, and according to the randomized treatment allocation previously notified by the principal investigator. The participant, investigator and outcomes assessor will be blinded to the study intervention.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours.
- •18 years or older.
- •No use of ivermectin prior to the study.
- •No known history of ivermectin allergy.
- •The patient can give his consent to take part in the study.
- •Not 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.
排除标准
- •COVID-19 pneumonia
- •Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles)
- •Positive pregnancy test for women of childbearing age*
- •Positive IgG against SARS-CoV-2 by rapid diagnostic test.
- •Negative SARS-CoV-2 PCR from a nasopharyngeal swab.
- •Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study. 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)
研究组 & 干预措施
Ivermectin
Participants on this arm will receive orally one (1) daily dose of ivermectin 300 mcg/kg for three (3) consecutive days, starting at the enrolment visit.
干预措施: Ivermectin (Drug)
Placebo
Participants on this arm will receive orally one (1) daily dose of placebo for three (3) consecutive days, starting at the enrolment 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
次要结局
- Seroconversion at day 21(Up to and including day 21)
- Proportion of drug-related adverse events(7 days post treatment)
- Levels of IgG, IgM and IgA(Up to and including day 21)
- Mean viral load(Baseline and on days 4, 7, 14 and 21)
- Fever and cough progression(Up to and including day 21)
- Presence of intestinal helminths(Baseline and on day 14.)
- Frequency of innate immune cells(Up to and including day 7)
- Frequency SARS-CoV-2-specific CD4+ T and and CD8+ T cells(Up to and including day 7)
- Results from cytokine Human Magnetic 30-Plex Panel(Up to and including day 21)