Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Real Time Polymerase Chain Reaction (RT-PCR) Positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Coronavirus Infectious Disease 2019 (COVID-19) Patients to RT- PCR-Negative as a Means to Reduce Hospitalization Rate
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 125
- 试验地点
- 3
- 主要终点
- RT-PCR negative status
研究概览
简要总结
To create a protocol for treatment of Pakistani patients with SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different quinone drug dosing regimens in controlling SARS-CoV-2 infection for asymptomatic patients.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nasopharyngeal RT-PCR positive SARS-CoV-2 patient
- •Age 20-50 years
- •BMI 18-28 kg/m2
- •Informed consent
排除标准
- •Symptoms: Cough, fever, shortness of breath
- •O2 saturation by pulse-oximeter below 94%
- •Co-morbidities: any pre-existing cardiac disease, pulmonary disease, diabetes
- •Arrhythmias and/or history of arrythmia
- •Psoriasis and/or history of psoriasis
- •Neuropathy or myopathy and/or history of these
- •Hypoglycemia and/or history of hypoglycemia
- •Pre-existing hepatic disease
- •Pre-existing renal disease
- •Use of antacids within 1 week
- •Use of antibiotics within 1 week
- •RT-PCR performed >3 days prior to enrollment
研究组 & 干预措施
Arm 1
Hydroxychloroquine loading dose (400 mg BID for 2 days) followed by 200 mg BID for 4 days plus standard of care
干预措施: Hydroxychloroquine Sulfate Regular dose (Drug)
Arm 2
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
干预措施: Hydroxychloroquine Sulfate Loading Dose (Drug)
Arm 3
Chloroquine 500 mg BID for 5 days plus standard of care
干预措施: Chloroquine (Drug)
Arm 4
Standard of care plus placebo (cannot be treated with hydroxychloroquine or chloroquine)
干预措施: Placebo (Drug)
结局指标
主要结局
RT-PCR negative status
时间窗: 6-7 days
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
次要结局
- Progression of symptoms(7 days)
- Development of Symptoms(7 days)
- Adverse events(7 days)
研究者
Ammar Sarwar
Assistant Professor of Radiology
Beth Israel Deaconess Medical Center