Randomized Placebo-controlled Trial of Hydroxychloroquine With or Without Azithromycin for Virologic Cure of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Proportion of virologically cured (PCR-negative status) as assessed on day six
研究概览
简要总结
Q-PROTECT is a placebo controlled randomized trial (RCT) to ascertain the efficacy of hydroxychloroquine (HC) alone or, in combination with azithromycin (AZ), in reducing viral load in patients with COVID 19.
详细描述
Reducing viral load is potentially key to reducing viral transmission between humans. Observational data suggests HC and AZ may reduce the viral load. In this study we will randomise ambulatory patients with Covid 19 (confirmed by PCR in combination with clinical symptoms) to receive HC/AZ or HC/placebo or placebo for 7 days. On days 2-14, participants will be reviewed by a member of the research team and samples will be obtained for viral load, an ECG recorded and physical examination performed. On days 15-20, participants will be reviewed by telephone using a semi structured questionnaire. On day 21 participants will be examined in person and an oronasopharyngeal swabs obtained for PCR analysis. Participants will be followed for 6 months via their medical records.
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
Double-blinded trial
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is in HMC facility for low-acuity, Covid-positive patients being quarantined.
- •Positive Covid test on qualitative assay used during routine care (i.e. not as part of Q-PROTECT)
- •Age at least 18
排除标准
- •Treating physician judges patient not appropriate for study participation for any reason
- •Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient)
- •Hypersensitivity to chloroquine or HC or AZ
- •History of or known QT prolongation
- •EKG required before study entry and on each visit during the subject's first seven days on pro-tocol, during the time period HC is being taken
- •Baseline QTc >480 if QRS width normal; QTc >510 if QRS >120
- •Known G6PD deficiency, porphyria, or retinopathy (eye exam prior to study entry)
- •Known hepatic or renal disease (or abnormality on liver or renal function testing at study day 1)
- •Low magnesium or low potassium (by testing on day 1)
- •Current (pre-study) therapy with antimalarial or dapsone
- •Current (pre-study) therapy with antiviral agents (e.g. oseltamivir)
- •Tisdale36 score exceeding 6 as tallied below (based on ACC recommendations)*
- •1 point each: age>67, female sex, or being on loop diuretic
- •2 points each: serum potassium <3.6, QTc>449, acute myocardial infarction
- •3 points each: sepsis, heart failure, QT-prolonging drugs
研究组 & 干预措施
Combination therapy group
hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
干预措施: Hydroxychloroquine (Drug)
Combination therapy group
hydroxychloroquine 200mg TID for 7 days plus Azithromycin 500mg OD 1st day and 250 from day 2 to 5
干预措施: Azithromycin (Drug)
Monotherapy therapy group
hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
干预措施: Hydroxychloroquine (Drug)
Monotherapy therapy group
hydroxychloroquine 200mg TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
干预措施: Placebo capsules (Other)
Control group
Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
干预措施: Placebo Tablet (Other)
Control group
Placebo Cap TID for 7 days plus Placebo 1 tab OD 1st day and 1 tab from day 2 to 5
干预措施: Placebo capsules (Other)
结局指标
主要结局
Proportion of virologically cured (PCR-negative status) as assessed on day six
时间窗: Day 6
Days
次要结局
- virologic cure on other study days(Day14 and Day 21)
- virologic semiquantitative analysis of changing viral load(Day 1 to Day 21)
- proportion of initially symtomatic subjects with disappearance of clinical symptoms(Day14 and Day 21)
- proportion of initially asymtomatic subjects with appearance of new clinical symptoms(Day14 and Day 21)
- proportions of subjects with potentially medication- related adverse events(7 day)
研究者
Tim Richard Edmund Harris
Professor Tim Richard Edmund Harris
Hamad Medical Corporation