NCT04311177已完成2 期
Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 4
- 主要终点
- Percentage of Participants Admitted to the Hospital
研究概览
简要总结
This is a multi-center, double-blinded study of COVID-19 infected patients randomized 1:1 to daily losartan or placebo for 10 days or treatment failure (hospital admission).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Positive laboratory test for COVID-19 based on local laboratory standard
- •Age greater than or equal to 18 years of age
- •One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (>101.5) or loss of taste / smell
排除标准
- •Randomization > 72 hours of meeting inclusion criteria
- •Randomization > 7 days of symptom onset
- •Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB)
- •Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to angioedema
- •Pregnant or breastfeeding women
- •Females able to have children not currently taking a protocol allowed version of contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g. medroxyprogesterone acetate/Depo-Provera), subcutaneous contraceptive (e.g. Nexplanon), daily oral contraceptives with verbalized commitment to taking daily throughout the study, condom use or abstinence during the study. All participants of child bearing potential enrolled in this fashion will be informed of the teratogenic risks.
- •Patient reported history or electronic medical record history of kidney disease, defined as:
- •Any history of dialysis
- •History of chronic kidney disease stage IV
- •Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 (must be have been measured within 1 month of enrollment)
- •Other kidney disease that in the opinion of the investigator, would affect losartan clearance
- •Patient reported dehydration and significantly decreased urine output in the past 72 hours
- •Most recent systolic blood pressure prior to enrollment <110 mmHg
- •Patient reported history or electronic medical record history of severe liver disease, defined as:
- •History of hepatitis B or C
- •Other liver disease that in the opinion of the investigator, would affect losartan clearance
- •Documented AST or ALT > 3 times the upper limit of normal within 3 months of randomization (if available in electronic medical record)
- •Potassium >5.0 mmol/L (must have been measured within 1 month) of enrollment
- •Concurrent treatment with aliskiren
- •Inability to obtain informed consent
- •Enrollment in another blinded randomized clinical trial for COVID
研究组 & 干预措施
Losartan
Experimental
Participants in this arm will receive the study drug, Losartan.
干预措施: Losartan (Drug)
Placebo
Placebo Comparator
Participants in this arm will receive a placebo treatment.
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Admitted to the Hospital
时间窗: 15 days
Outcome reported as the percentage of participants per arm admitted to inpatient hospital care due to COVID-19-related disease within 15 days of randomization. Currently, there is a pre-planned pooled analysis with a national trial network under development.
次要结局
- Change in PROMIS Dyspnea Scale(10 days)
- Change in SF-12 Physical Composite Score(10 days)
- Change in SF-12 Mental Composite Score(10 days)
- Count of Participants With an Emergency Department or Clinic Presentation(28 days)
- Disease Severity Rating Day 15(15 days)
- Daily Maximum Temperature(10 days)
- Change in Viral Load by Nasopharyngeal Swab at Day 9(9 days)
- Change in Viral Load by Nasopharyngeal Swab at Day 15(15 days)
- Percentage of Patients Admitted to the Intensive Care Unit Within 15 Days(15 days)
- Need for Oxygen Therapy at 15 Days(15 days)
研究者
研究点 (4)
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