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临床试验/NCT04351191
NCT04351191终止4 期

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

Government of Punjab, Specialized Healthcare and Medical Education Department4 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2020年4月15日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Experimental

Hydroxychloroquine loading dose (400 mg BID) alone plus standard of care

干预措施: Hydroxychloroquine Sulfate Loading Dose (Drug)

CQ regular dose

Active Comparator

Cholorquine 500 mg BID for 5 days plus standard of care

干预措施: Chloroquine (Drug)

Placebo

Placebo Comparator

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

发起方
Government of Punjab, Specialized Healthcare and Medical Education Department
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Ammar Sarwar

Assistant Professor, Harvard Medical School

Beth Israel Deaconess Medical Center

研究点 (4)

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