NCT04312009已完成2 期
Randomized Controlled Trial of Losartan for Patients With COVID-19 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
- 205
- 试验地点
- 13
- 主要终点
- Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days
研究概览
简要总结
This is a multi-center, double-blinded study of COVID-19 infected patients requiring inpatient hospital admission randomized 1:1 to daily Losartan or placebo for 7 days or hospital discharge.
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
- •Presumptive positive laboratory test for Covid-19 based on local laboratory standard
- •Age greater than or equal to 18 years of age
- •Admission to the hospital with a respiratory SOFA >=1 and increased oxygen requirement compared to baseline among those on home O2
- •Randomization within 48 hours of presentation of hospital admission or within 48 hours of a positive test result, whichever is later
排除标准
- •Randomization > 48 hours of admission order or positive test result, whichever is later
- •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
- •Lack of negative urine or serum pregnancy test
- •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 period; use of condoms or agree to abstain from sexual intercourse during the study. All women of child bearing age enrolled in this fashion will be informed of the teratogenic risks. If enrolled under LAR, they will be informed of the risks after regaining capacity.
- •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 at the time of randomization
- •Severe dehydration at the time of enrollment in the opinion of the investigator or bedside clinician
- •Most recent mean arterial blood pressure prior to enrollment <65 mmHg
- •Patient reported history or electronic medical record history of severe liver disease, defined as:
- •History of hepatitis B or C
- •Documented AST or ALT > 3 times the upper limit of normal measured within 24 hours prior to randomization
- •Potassium >5.0 within 24 hours prior to randomization unless a repeat value was <=5.0
- •Treatment with aliskiren
- •Inability to obtain informed consent from participant or legally authorized representative
- •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
Difference in Estimated (PEEP Adjusted) P/F Ratio at 7 Days
时间窗: 7 days
Outcome calculated from the partial pressure of oxygen or peripheral saturation of oxygen by pulse oximetry divided by the fraction of inspired oxygen (PaO2 or SaO2 : FiO2 ratio). PaO2 is preferentially used if available. A correction is applied for endotracheal intubation and/or positive end-expiratory pressure. Patients discharged prior to day 7 will have a home pulse oximeter send home for measurement of the day 7 value, and will be adjusted for home O2 use, if applicable. Patients who died will be applied a penalty with a P/F ratio of 0.
次要结局
- Daily Hypotensive Episodes(10 days)
- Proportion of Participants Requiring Vasopressors for Hypotension(10 days)
- Proportion of Participants Experiencing Acute Kidney Injury(10 days)
- Oxygen Saturation / Fractional Inhaled Oxygen (S/F)(7 days)
- 90-Day Mortality(90 days)
- Number of Therapeutic Oxygen-Free Days(28 days)
- 28-Day Mortality(28 days)
- ICU Admission(10 days)
- Number of Ventilator-Free Days(28 days)
- Number of Vasopressor-Free Days(10 days)
- Length of Hospital Stay(90 days)
- Change in Viral Load by Nasopharyngeal Swab Day 15(15 days)
- Disease Severity Rating(28 days)
研究者
研究点 (13)
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