Comparative Efficacy of Various Doses of Hydroxychloroquine in Pre-Exposure Prophylaxis for COVID 19 in Healthcare Personnel
试验速览
- 阶段
- 2 期
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- COVID-19-free survival in experimental arms compared to placebo
研究概览
简要总结
Hydroxychloroquine has been approved by FDA as one of the treatment options for COVID 19.Healthcare personnel are amongst those at highest risk to contract the disease. Several health authorities are now recommending the use of hydroxychloroquine as pre-exposure prophylaxis is in health care personnel. Several studies are on going in this context. However there is a controversy regarding the dosage regimen. This drug has a half life of 22.4 days. In this study we will be comparing three different doses of Hydroxychloroquine and additionally have a control group in order to determine the efficacy of hydroxychloroquine as pre- exposure prophylaxis in healthcare personnel in various doses.
详细描述
Study design:
Phase 2 proof of concept study Study Type: Interventional (Clinical Trial) Estimated Enrollment : at least 200 participants Since the investigators have no current data on pre-exposure prophylaxis to calculate sample size statistically, so a minimum of 50 participants in each arm will be recruited including 20% attrition rate. The investigators will be recruiting a minimum of 200 participants in the study , that is at least 50 in each of the four arms.
Allocation: Randomized Intervention Model: Parallel Assignment Study model: Parallel group interventional study Location: SZABMU/PIMS Study duration: a minimum of 12 weeks from recruitment
Materials and Methods:
Participants will be recruited after approval from Ethical Review Board .A written informed consent will be taken from all participants. Participants fulfilling the eligibility criteria will be randomized to 4 arms.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Active COVID-19 disease;
- •Confirmed prior COVID-19 disease;
- •Current fever, cough, shortness of breath;
- •Contraindication or hypersensitivity to chloroquine or hydroxychloroquine ad hypersensitivity to 4-aminoquinoline compounds;
- •Pregnancy;
- •Lactation;
- •Prior retinal eye disease;
- •Known Chronic Kidney disease, Stage 4 or 5 or dialysis;
- •Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency ;
- •Weight <40 kg;
- •Current use of chloroquine,hydroxychloroquine or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone;
- •Current use of medications with known significant drug-drug interactions: artemether, lumefantrine, mefloquine, tamoxifen or methotrexate;
- •Current use of medications causing QT interval prolongation like: macrolides,antipsychotics,quinolones,antihistamines,SSRIs,tricyclic antidepressants, antifungals;
- •Recent Myocardial Infarction;
- •History of Epilepsy
研究组 & 干预措施
Arm 1
Hydroxychloroquine Sulphate will be administered at a dose of 400mg twice a day on day 1 followed by 400 mg once a week for a total of 12 weeks
干预措施: Hydroxychloroquine Sulfate 200 MG (Drug)
Arm 2
Hydroxychloroquine Sulphate will be admoinistered at a dose of 400 mg on day 1 followed by 400mg once every 3 weeks for at total of 12 weeks
干预措施: Hydroxychloroquine Sulfate 200 MG (Drug)
Arm 3
Hydroxychloroquine Sulphate will be administered at a dose of 200 mg on day 1 followed by 200 mg once every 3 weeks for a total of 12 weeks
干预措施: Hydroxychloroquine Sulfate 200 MG (Drug)
Arm 4
Control group will recieve Placebo 200mg on day 1 followed by Placebo 200mg every three weeks for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
COVID-19-free survival in experimental arms compared to placebo
时间窗: 12 weeks
Outcome reported as the percentage of participants in each arm who are COVID-19-free at the end of study treatment
次要结局
- Ordinal Scale of COVID-19 Disease maximum severity if COVID-19 diagnosed at study end(12 weeks)
- Incidence of confirmed SARS-COV-2 detection(12 weeks)
- Incidence of Hospitalization for COVID-19 or death(12 weeks)
- Incidence of possible COVID-19 symptoms(12 weeks)
- Incidence of all-cause study medicine discontinuation(12 weeks)
- Incidence of study medication-related adverse events(12 weeks)
研究者
Fibhaa Syed
Assistan Professor Medicine
Shaheed Zulfiqar Ali Bhutto Medical University