Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 4
- 主要终点
- World Health Organization (WHO) Ordinal Scale Measured at 14 Days After Enrollment
研究概览
简要总结
This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens:
Arm 1: Standard of care alone
Arm 2: Standard of care plus hydroxychloroquine
Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups:
- Standard of care alone
- Standard of care plus hydroxychloroquine
- Standard of care plus azithromycin
- Standard of care plus hydroxychloroquine plus azithromycin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to participating hospital with symptoms suggestive of COVID-19 infection OR develop symptoms of COVID-19 during hospitalization
- •Subject (or legally authorized representative) can provide written informed consent (in English or Spanish) affirming intention to comply with planned study procedures prior to enrollment
- •Male or female adult aged 12 years or older at the time of enrollment
- •Has laboratory-confirmed SARS-CoV-2 infection determined by a validated nucleic acid amplification assay (public health or commercial) in any respiratory specimen collected within 14 days of randomization
- •Illness of any duration that includes
- •Radiographic evidence of pulmonary infiltrates (chest X-ray or CT scan) OR
- •Clinical documentation of lower respiratory symptoms (cough, shortness of breath, wheezing) OR
- •Any documented SpO2 ≤ 94% on room air OR
- •Any inpatient initiation or supplemental oxygen regardless of documented cause
排除标准
- •Participating in any other clinical trial of an experimental agent for COVID-19
- •On hydroxychloroquine at any time during hospitalization, or within 180 days of hospitalization for COVID-19 regardless of indication
- •History of G6PD deficiency, cirrhosis, long QT syndrome or porphyria of any classification
- •Most recent ECG prior to time of screening with QTc of ≥500 msec
- •Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
- •Death anticipated within 48 hours of enrollment
- •Inability to obtain informed consent from the patient or designated medical decision maker
研究组 & 干预措施
Standard of care
干预措施: Standard of care (Other)
Standard of care plus hydroxychloroquine
Standard of care plus hydroxychloroquine for 5 days
干预措施: Standard of care (Other)
Standard of care plus hydroxychloroquine
Standard of care plus hydroxychloroquine for 5 days
干预措施: Hydroxychloroquine (Drug)
Standard of care plus azithromycin
Standard of care plus azithromycin for 5 days
干预措施: Standard of care (Other)
Standard of care plus azithromycin
Standard of care plus azithromycin for 5 days
干预措施: Azithromycin (Drug)
Standard of care plus hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine plus azithromycin for 5 days
干预措施: Standard of care (Other)
Standard of care plus hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine plus azithromycin for 5 days
干预措施: Hydroxychloroquine (Drug)
Standard of care plus hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine plus azithromycin for 5 days
干预措施: Azithromycin (Drug)
结局指标
主要结局
World Health Organization (WHO) Ordinal Scale Measured at 14 Days After Enrollment
时间窗: Day 14
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
次要结局
- Number of Patients Not Receiving Mechanical Ventilation at Baseline Who Progress to Requiring Mechanical Ventilation During the Index Hospitalization(Index hospitalization, up to 46 days)
- Number of Participants With Severe Adverse Events(Day 14)
- Number of Participants Who Died During the Index Hospitalization(Index hospitalization, up to 46 days)
- Number of Days on Mechanical Ventilation(Baseline)
- Hospital Length of Stay in Days for the Index Hospitalization(Index hospitalization, up to 46 days)
- WHO Ordinal Scale Measured at 28 Days After Enrollment(Day 28)
- Number of Participants With All-cause Study Medication Discontinuation(Index hospitalization, up to 46 days)