An aDaptive, multicEnter, rAndomized, Open-Label, Controlled Trial to Assess Effectiveness and Safety of Quinine Sulfate for COVID-19 in Hospitalized Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The clinical condition of the subjects assessed on a 7-point ordinal scale
研究概览
简要总结
This is a multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of Quinine Sulfate as an add-on therapy in hospitalized adults with COVID-19.
The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for safety and effectiveness. Any changes would be accompanied by an updated sample size.
Subjects will be assessed while hospitalized. All subjects will undergo a series of laboratory tests (CBC, SGOT, SGPT, Ureum, Creatinine, EKG, and PCR), clinical examination (clinical assessment, vital signs, accompanying drugs, and other medical conditions) and safety assessment (serious adverse events/ SAE)
Randomization will be performed 1:1 for each arm. Arm 1 = Standard of Care (SoC) alone, arm 2 = SoC + Quinine Sulfate
详细描述
This is an adaptive, multicenter, randomized, open-label, controlled trial to evaluate the effectiveness and safety of quinine sulfate in mild to moderate COVID-19 hospitalized adults with confirmed positive Rapid Test or PCR.
The study is a multi-center trial that will be conducted in up to approximately 2 sites nationally. New sites may be added as needed after appropriate assessment. Interim monitoring will be conducted to evaluate the arms and for effectiveness and safety. Any change would be accompanied by an updated sample size.
Eligible patients are male and female patients aged ≥ 18 years to < 60 years old who are hospitalized with Covid-19 based on clinical symptoms determined by physician and confirmed by Rapid Test or PCR test with mild to moderate symptoms that fulfill the inclusion and exclusion criteria stated in the protocol. Total Subjects: 100
Subjects with any of these conditions will be excluded:
- Received quinine sulfate, hydroxychloroquine, chloroquine, lumefantrine, or mefloquine within 30 days prior to this research;
- Having receive any treatment for COVID-19 prior to this research;
- Any contraindication to quinine sulfate
- Inability to swallow pills or any other reason that compliance with the medical regimen is not likely;
- Pregnant and breastfeeding;
- Severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgement (e.g. retinopathy, cardiovascular disease (QTc > 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine > 2x normal value), liver disease (SGOT/SGPT > 2x normal value), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia;
- Platelet count less than 150,000 and more than 450,000 cells/μL;
- Possibility of being transferred to a non-study-hospital within 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥ 18 years to 50 years old who are hospitalized with Covid-19 based on clinical symptoms determined by physician and confirmed by Rapid Test or PCR test with mild to moderate symptoms
- •Female subjects of child-bearing age agree to take effective contraceptive measures during the study until seven days of the last oral medication
- •Willing to receive a random assignment to any designated treatment group and not participating in another study at the same time
- •Not participating in other research at the same time.
- •Subjects agreed to participate in the study and signed an information sheet and informed consent.
排除标准
- •Received quinine sulfate, hydroxychloroquine, chloroquine, lumefantrine, or mefloquine within 30 days prior to this research;
- •Having receive any treatment for COVID-19 prior to this research;
- •Any contraindication to quinine sulfate
- •Inability to swallow pills or any other reason that compliance with the medical regimen is not likely;
- •Pregnant and breastfeeding;
- •Severe underlying disease where treatment and follow up is not likely to be beneficial to the patient based on physician judgement (e.g. retinopathy, cardiovascular disease (QTc > 500 mdet (narrow QRS); QTc ≥ 550 mdet (wide QRS)), heart arrythmia, uncontrolled diabetes mellitus, hypertension, chronic pulmonary disease, asthma, chronic kidney disease (Creatinine > 2x normal value), liver disease (SGOT/SGPT > 2x normal value), chronic neurological disease, or etc.). This includes people requiring care in designated supported living facilities and severe dementia;
- •Platelet count less than 150,000 and more than 450,000 cells/μL;
- •Possibility of being transferred to a non-study-hospital within 72 hours.
研究组 & 干预措施
Control Group
Standard of Care alone
干预措施: Standard of Care (Drug)
Experimental Group
Standard of Care + Quinine Sulfate
干预措施: Standard of Care + Quinine Sulfate (Drug)
结局指标
主要结局
The clinical condition of the subjects assessed on a 7-point ordinal scale
时间窗: From the date of randomization until the date of first documented subject discharge or death from any cause, assessed up to 10 days
The clinical condition of the subjects was assessed until day 10 using a 7-point ordinal scale, as follows: 1. Death 2. Hospitalization, with invasive mechanical ventilation or ECMO 3. Hospitalization, with non-invasive ventilation or high-flow oxygen device; 4. Hospitalized, requires additional oxygen; 5. Hospitalized, does not require additional oxygen; 6. Not hospitalized, activity restrictions; 7. No hospitalization, no activity restrictions
次要结局
- Length of stay(From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days)
- Duration of ventilation(From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days)
- Duration of oxygenation(From the date of randomization until the date of first documented subject discharge or death from anycause, assessed up to 10 days)
研究者
Keri Lestari
Prof. Dr. Keri Lestari, M.Si, S.Si, Apt.
Universitas Padjadjaran