A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of Participants Who Are Virus Free
研究概览
简要总结
To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo.
The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.
详细描述
Hydroxychloroquine (HCQ), which is a less toxic derivative of chloroquine (CQ), has been shown to be effective in inhibiting Covid-19 infection in vitro. The evidence from clinical research trials is sparse and has many flaws. Much of the Chinese experience with Chloroquine comes from a letter to the editor and a news briefing/conference held on February 15, 2020. The letter describes experience with more than 100 patients treated with CQ in multicenter clinical trials but the letter provides no quantitative data to back their claims. At least one non-randomized clinical trial has been performed in Europe. Covid-19 infected patients received 10 days of HCQ daily and underwent daily testing of viral loads from nasopharyngeal swabs. The subjects receiving HCQ were much more likely (P<0.02) to clear their viral load than subjects who did not receive HCQ. The study had many flaws, which make the conclusions less valuable than rigorously designed randomized clinical trial. This study is designed as a randomized, blinded trial to either confirm or refute the efficacy of HCQ in early treatment of Covid19 infection to ameliorate disease severity, and reduce viral load.
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)
盲法说明
Blinded to subject and investigators
入排标准
- 年龄范围
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms occurring within 3 days prior to patient presenting to USA Facility for PCR nasopharyngeal swab
- •Nasopharyngeal swab positive for Covid-19 infection and/or exposure and/or symptoms congruent with fever and cough
- •Male or Female age 19 to 89 years
- •Able to take oral medications
- •Patients not requiring hospitalization
- •Provision of informed consent
排除标准
- •Known history of EKG QTc prolongation abnormality
- •Contraindication or allergy to hydroxychloroquine
- •Retinal eye disease
- •Known glucose-6 phosphate dehydrogenase (G-6-PD) deficiency
- •Known chronic kidney disease, stage 4 or 5 or receiving dialysis
- •Weight < 40 kg
- •Current use of: hydroxychloroquine or cardiac medicines of: flecainide, Tambocor; amiodarone, Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or Procan, Procanbid, propafenone, Rythmal)
- •Known hepatic disease (cirrhosis, hepatitis)
- •Active treatment for cancer (chemotherapy, radiation, surgery within 3 months
- •On immunosuppressive drugs steroids, antirejection medications.
- •Recipient of solid organ transplant
- •Pregnancy/breastfeeding
- •Past medical history Porphyria (may exacerbate disease)
- •PMH Psoariasis (can worsen disease)
- •No access to internet or email
- •Current suicidal thoughts according to Columbia scale
- •In the screening process before signing consent, subjects will be asked if they are suicidal. If this response is yes, patients will be excluded from trial and directed to the National Suicide Prevention Lifeline: 1-800-273-8255.
研究组 & 干预措施
Hydroxychloroquine
Subjects in this arm will receive the study drug
干预措施: Hydroxychloroquine (Drug)
Placebo
Subjects in this arm will take placebo for 6 days
干预措施: Placebo (Other)
结局指标
主要结局
Number of Participants Who Are Virus Free
时间窗: 7 days after initiation of trial
Nasopharyngeal swab PCR measurement of viral load expressed as the % of negative PCR swabs
Disease Severity
时间窗: 6 days
Participants will self-report disease severity status as one of the following 5 options; no COVID19 illness (score of 1), COVID19 illness with no hospitalization (score of 2), or COVID19 illness with hospitalization (score of 3), or Covid 19 with care requiring hospitalization (score of 4), or Covid 19 with death (Score of 5) .
次要结局
- Number of Participants Who Discontinue or Withdraw Medication Use for Any Reason(14 days)
- Number of Participants Who Have Confirmed Covid 19 Infection(14 days)
- Number of Participants Who Are Hospitalized for Covid 19 Infection(14 days)
- Number of Participants Who Die Secondary to Covid 19 Infection(70 Days (10 weeks))
- Immunity to Covid-19(70 days (10 weeks))
研究者
William Richards
Professor and Chair Surgery
University of South Alabama