Safety And Efficacy Of Hydroxychloroquine For At Risk Population (SHARP) Against COVID-19- A Cluster Randomized Controlled Trial (SHARP COVID-19 RCT)
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 主要终点
- positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.
研究概览
简要总结
The Coronavirus Disease 2019 (COVID-19) pandemic has placed tremendous stress on the global economy since its outbreak in December 2019. Currently, with nearly 1.3 million confirmed cases, there is still no effective way to contain the disease. The transmission of COVID-19 occurs via direct (prolonged close interaction, within 2 meters for more than 30 minutes) and indirect (fomites) contacts. Locally, the risk of COVID-19 infection in household contacts of confirmed cases is about 4%. These at-risk individuals are identified through contact tracing and infectious may be preventable using post-exposure-prophylaxis (PEP). However, there has yet to be a single effective, safe, and affordable pharmacological agent with such capabilities. Hydroxychloroquine (HCQ) is a cheap anti-malarial and immunomodulatory agent which may potentially be used as PEP against COVID-19. HCQ is capable of blocking the invasion and intracellular replication of the virus. Existing studies have reported efficacy of HCQ in treating COVID-19, with reduced time to clinical recovery and few reports of patients suffering from significant side effects. However, existing studies are largely limited by their small sample sizes. Furthermore, there has yet to be a published trial on HCQ's role in PEP. This cluster randomized trial will evaluate the safety and efficacy of oral HCQ PEP, taken over for 5 days, in reducing the number of infected household contacts of confirmed COVID-19 patients under home quarantine. Comparison will be made between HCQ PEP (treatment group) and no treatment (control group). Subjects will be followed up over a course of 28 days, with daily symptom monitoring conducted over phone calls. Positive outcomes from this study will provide a means for us to battle the COVID-19 pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Person diagnosed with COVID-19 infection.
- •Pregnant at the time of screening or breastfeeding.
- •Known allergy or hypersensitivity to HCQ or other aminoquinoline compounds.
- •Already on HCQ for different indications (e.g., rheumatological diseases, malaria prophylaxis)
- •Diagnosis of other systemic viral or bacterial infection.
- •Use of systemic immunosuppressant agents within 90 days of enrollment (e.g., corticosteroids and immunomodulatory therapy)
- •History of immunocompromised state.
- •History of psychiatric illness.
- •History of psoriasis or porphyria.
- •History of cardiac disease.
- •Other major comorbidities that contraindicate the use of HCQ: i. Hematologic malignancy, ii. Stage 4-5 chronic kidney disease or end-stage renal failure, iii. history of ventricular arrhythmias, iv. current use of drugs that prolong the QT interval
- •History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.
- •Bradycardia <50beats/min.
- •Uncorrected hypokalemia
- •Uncorrected hypomagnesemia.
- •Unwillingness to practice acceptable methods of birth control (both males who have partners of childbearing potential and females of childbearing potential) while on study and for at least 30 days after last dose.
研究组 & 干预措施
Intervention
Treatment arm will be given Hydroxychloroquine sulfate. Dose: 800 milligrams (mg) (4 pills of 200mg) in two divided doses on day 1 followed by 400mg (2 pills of 200mg) in two divided doses on day 2, 3,4, 5.
Mode of administration: Oral pills of 200mg of HCQ; Supply: The total supply of all the pills (12 pills of 200mg per subject in the study group) will be given to the recruited subject from day 1.
干预措施: Hydroxychloroquine Sulfate 200 milligram (mg) Tab (Drug)
Standard Preventive Measures
No intervention. Standard recommended preventive measures by the ministry of health.
干预措施: Hydroxychloroquine Sulfate 200 milligram (mg) Tab (Drug)
结局指标
主要结局
positive serology or reverse transcriptase (RT-PCR) for COVID-19 up until day 28.
时间窗: Until day 28
COVID-19 infection
次要结局
- Positive serology at day 28.(28 days)
- Symptoms of COVID-19.(Until day 28)