Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Percent of Participants With Grade 3 or 4 AEs Through Day 30
研究概览
简要总结
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
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
Double-blind
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
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Hospitalized adult (≥18 years old) with symptoms consistent with COVID-19 including but not limited to any of the following: fever (documented or subjective), cough, dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
- •Informed consent signed by patient
- •Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or bronchoalveolar lavage) o The testing may:
- •Occur up to ≤72h prior to informed consent of participation in the study
- •Be undertaken either on-site or in an external laboratory certified by New York State to run testing for SARS-CoV-2
- •Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or vasopressor requirement) at time of randomization.
- •Treatment with CQ or HCQ within the 30 days prior to the start of the study drug treatment.
- •Participation in a clinical trial to investigate a non-FDA approved drug with the intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug treatment.
- •Unable to take oral medications.
- •History of allergic reaction or intolerance to CQ or HCQ.
- •Baseline corrected qT interval >470 milliseconds (male) or >480 milliseconds (female), history of congenital qT prolongation, and/or history of cardiac arrest.
- •Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone, thioridazine, or pimozide
- •History of retinal disease including a documented history of diabetic retinopathy.
- •Known history of G6PD deficiency.
排除标准
- 未提供
研究组 & 干预措施
Hydroxychloroquine
干预措施: Hydroxychloroquine (HCQ) (Drug)
结局指标
主要结局
Percent of Participants With Grade 3 or 4 AEs Through Day 30
时间窗: 30 days
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Percent of Participants With Discontinuation of Therapy (for Any Reason)
时间窗: 30 days
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Percent of Participants With SAE Through Day 30
时间窗: 30 days
The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100)
Percent of Participants Showing a Severe Disease Progression Composite Outcome
时间窗: 14 days
Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE). The measure value is reported as a percentage (# of patients with outcome/ # of patients \* 100).
次要结局
- Days of Non-rebreather Mask Oxygen Supplementation(14 days)
- Hospital Length of Stay(30 days)
- Percent of Subjects With Q-T Interval, Corrected (qTC) Prolongation at End of Treatment (EOT)(6 Days)
- Percent of Participants Who Required Invasive Mechanical Ventilation(30 Days)
- Change in Platelet Count(Baseline, 6 days)
- Change in White Blood Cell (WBC) Count(Baseline, 6 days)
- Change in Lactate Dehydrogenase (LDH) Levels(Baseline, 6 days)
- Change in C-Reactive Protein (CRP) Levels(Baseline, 6 days)
- Days of Non-invasive Ventilator Use(14 days)
- Days of Fever(14 days)
- Percent of Patients Who Resulted in Mortality(30 days)
- Percent of Participants Who Required ICU Admission(30 Days)
- Change in Aspartate Aminotransferase (AST) Levels(Baseline, 6 days)
- Change in Creatinine Levels(Baseline, 6 days)
- Number of Participants With Mild, Moderate, and Severe Scores on Cytokine Release Syndrome (CRS) Grading Scale(Day 1)
- Percent of Participants Who Required Extracorporeal Membrane Oxygenation (ECMO)(30 Days)
- Percent of Participants With Hypotension Requiring Vasopressor Support(30 Days)
- Percent of Participants With SARS-CoV-2 Viral Eradication From Nasopharyngeal Specimens at EOT(6 days)
- Change in Alanine Aminotransferase (ALT) Levels(Baseline, 6 days)
- Change in Glucose Levels(Baseline, 6 days)
- Change in Interleukin 6 (IL-6) Levels(Baseline, 6 days)
- Change in Hemoglobin Levels(Baseline, 6 days)
- Change in Total Bilirubin Levels(Baseline, 6 days)