Use and Dosage of Hydroxychloroquine and Chloroquine to Convert Symptomatic 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
- 137
- 试验地点
- 4
- 主要终点
- RT-PCR result
研究概览
简要总结
To treat Pakistani patients with non-life threatening symptomatic SARS-CoV-2 infection with an intent to reduce burden on institutional healthcare services by determining efficacy of different chloroquine and hydroxychloroquine dosing regimens in controlling SARS-CoV-2 infection.
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
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic patients: defined as fever (temperature greater than 100 degree F), cough, or shortness of breath (respiratory rate >22 per minute).
- •Nasopharyngeal RT-PCR positive SARS-CoV-2
- •Age 20-50 years
- •BMI 18-28 kg/m2
- •Informed consent
排除标准
- •O2 saturation by pulse-oximeter below 93%
- •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 antiobiotics within 1 week
- •RT-PCR performed >7 days prior to enrollment
研究组 & 干预措施
HCQ Regular dose
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)
HCQ Loading dose
Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care
干预措施: Hydroxychloroquine Sulfate Loading Dose (Drug)
CQ regular dose
Cholorquine 500 mg BID for 5 days plus standard of care
干预措施: Chloroquine (Drug)
Placebo
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 result
时间窗: 6th and 7th day
Percentage of patients who become RT-PCR negative with two RT-PCR tests performed at day 6 and day 7
次要结局
- Mortality(30 days)
- Progression of symptoms(7 days)
研究者
Ammar Sarwar
Assistant Professor, Harvard Medical School
Beth Israel Deaconess Medical Center