Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 77
- 试验地点
- 1
- 主要终点
- Incidence of severe complications due COVID-19 infection
研究概览
简要总结
Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
详细描述
This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19.
The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan.
We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.
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, Care Provider)
盲法说明
doubled-blind and placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age greater than or equal to 18 years of age
- •Ability to understand and sign informed consent
- •Biopsy-proven diagnosis of previous cancer (solid or hematologic disease)
- •Participants must be diagnosed with active malignancy, defined as the presence of metastatic disease; or patient undergoing curative treatment during cancer treatment, regardless of the therapeutic modality.
- •Confirmed diagnosis of COVID-19 by the presence of a positive PCR test or positive serological test and / or diagnosis presumed by the presence of flu-like symptoms associated to suggestive findings on CT scan.
- •ECOG performance status 0 to 2
- •Patients must have an assessment of adequate organ function within 28 days prior to enrollment, evidenced by:
- •Hemoglobin ≥ 9.0 g / dL
- •Leukometry> 2,000 / mm3
- •Absolute neutrophil count ≥ 1,500 / mm3
- •Platelet count ≥ 100,000 / mm3
- •Creatinine clearance ≥ 30 mL / min. Creatinine clearance (CrCl) should be calculated according to the Cockcroft-Gault formula.
- •Total bilirubin <3 x the upper limit of normal (ULN), except for patients with known Gilbert's syndrome.
- •Aspartate aminotransaminase (AST) <3.0 x LSN.
- •Alanine aminotransaminase (ALT) <3.0 x ULN.
排除标准
- •Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB).
- •Patients who presents with severe conditions at the time of diagnosis requiring ICU admission.
- •Prior reaction or intolerance to an ARB or ACE inhibitor.
- •Blood pressure less than 110/70 mmHg at presentation
- •Potassium greater than 5.0 mEq / L
- •Pregnancy or breastfeeding
- •Prior reaction to Ivermectin.
- •Patient currently enrolled in another research protocol
研究组 & 干预措施
ARM A: Placebo
Patients will receive ivermectin-placebo single dose on the day of confirmed diagnosis of COVID-19, followed by losartan-placebo daily for 15 days.
干预措施: Placebo (Drug)
ARM B: Ivermectin plus losartan
Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days
干预措施: Ivermectin (Drug)
ARM B: Ivermectin plus losartan
Patients will receive a single dose of 12mg of ivermectin on the day of the confirmed diagnosis of COVID-19, followed by losartan 50mg orally once daily for 15 consecutive days
干预措施: Losartan (Drug)
结局指标
主要结局
Incidence of severe complications due COVID-19 infection
时间窗: 28 days
Incidence of severe complications due COVID-19 infection defined as need for ICU admission, need for mechanical ventilation, or death
次要结局
- Incidence of Severe Acute Respiratory Syndrome(28 days)
- Adverse events(28 days)
- Overall survival(28 days)