Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 40
- 主要终点
- COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization)
研究概览
简要总结
ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.
详细描述
Effective therapies for COVID-19 are urgently needed. Hydroxychloroquine is an antimicrobial agent with immunomodulatory and antiviral properties that has demonstrated in vitro activity against SARS-CoV-2, the virus that causes COVID-19. Preliminary reports suggest potential efficacy in small human studies. Clinical trial data are needed to determine whether hydroxychloroquine is effective in treating COVID-19.
Study Aim: To compare the effect of hydroxychloroquine versus placebo on clinical outcomes, measured using the COVID Ordinal Outcomes Scale at Day 15, among adults with COVID-19 requiring hospitalization.
Study Hypothesis: Among adults hospitalized with COVID-19, administration of hydroxychloroquine will improve clinical outcomes at Day 15.
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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
Patients, treating clinicians, trial personnel, and outcome assessors will be blinded to group assignment.
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
- •Age ≥18 years
- •Currently hospitalized or in an emergency department with anticipated hospitalization.
- •Symptoms of acute respiratory infection, defined as one or more of the following:
- •fever (> 37.5° C / 99.5° F)
- •shortness of breath (operationalized as any of the following: subjective shortness of breath reported by patient or surrogate; tachypnea with respiratory rate ≥22 /minute; hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy).
- •sore throat
- •Laboratory-confirmed SARS-CoV-2 infection within the past 10 days prior to randomization.
排除标准
- •Breast feeding
- •Symptoms of acute respiratory infection for >10 days before randomization
- •>48 hours between meeting inclusion criteria and randomization
- •Seizure disorder
- •Porphyria cutanea tarda
- •Diagnosis of Long QT syndrome
- •QTc >500 ms on electrocardiogram within 72 hours prior to enrollment
- •Known allergy to hydroxychloroquine, chloroquine, or amodiaquine
- •Receipt in the 12 hours prior to enrollment, or planned administration during the 5-day study period that treating clinicians feel cannot be substituted for another medication, of any of the following: amiodarone; cimetidine; dofetilide; phenobarbital; phenytoin; sotalol
- •Receipt of >1 dose of hydroxychloroquine or chloroquine in the 10 days prior to enrollment
- •Inability to receive enteral medications
- •Refusal or inability to be contacted on Day 15 for clinical outcome assessment if discharged prior to day 15
- •Previous enrollment in this trial
- •The treating clinical team does not believe equipoise exists regarding the use of hydroxychloroquine for the treatment of this patient
研究组 & 干预措施
Hydroxychlorquine
Participants assigned to the hydroxychloroquine arm will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.
干预措施: Hydroxychloroquine (Drug)
Placebo
Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.
干预措施: Placebo (Drug)
结局指标
主要结局
COVID Outcomes Scale Score on Study Day 15 (14 Days After Randomization)
时间窗: Assessed on study day 15
We will determine the COVID Ordinal Scale for all patients on study day 15 COVID Ordinal Scale defined as: 1. Death 2. Hospitalized on invasive mechanical ventilation or ECMO ( extracorporeal membrane oxygenation) 3. Hospitalized on non-invasive ventilation or high flow nasal cannula 4. Hospitalized on supplemental oxygen 5. Hospitalized not on supplemental oxygen 6. Not hospitalized with limitation in activity (continued symptoms) 7. Not hospitalized without limitation in activity (no symptoms)
次要结局
- COVID Ordinal Outcomes Scale on Study Day 29 (28 Days After Randomization)(assessed on study day 29)
- All-location, All-cause Mortality Assessed on Study Day 15 (14 Days After Randomization)(assessed on study day 15)
- Oxygen-free Days Through Day 28(28 days after randomization)
- COVID Ordinal Outcomes Scale on Study Day 3 (2 Days After Randomization)(assessed on study day 3)
- COVID Ordinal Outcomes Scale on Study Day 8 (7 Days After Randomization)(assessed on study day 8)
- All-location, All-cause Mortality Assessed on Study Day 29 (28 Days After Randomization)(assessed on study day 29)
- Number of Patients Dead or With Receipt of ECMO Between Enrollment and Day 28(Enrollment to Day 28)
- Ventilator-free Days Through Day 28(28 days after randomization)
- Vasopressor-free Days Through Day 28(28 days after randomization)
- ICU-free Days to Day 28(28 days after randomization)
- Hospital-free Days to Day 28(28 days after randomization)
研究者
Boyd Taylor Thompson
Co-Prinicipal Investigator PETAL CCC
Massachusetts General Hospital