Study Design of the Diacerein Effect on Inflammatory Response in Patients With Covid-19: a Randomized, Placebo-controlled, Double-blind Trial.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Serum levels of cytokines, troponin-T and D-dimer
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind trial pilot study. This study will include individuals over 18 years of age who have been hospitalized with a confirmed diagnosis of COVID-19 to assess whether DIACEREIN treatment is safe and effective in controlling or decreasing inflammation in the body and viral load (amount of virus in the body in these patients).
详细描述
Study Design This is a randomized, placebo-controlled, double-blind trial pilot study designed to verify whether diacerein attenuates systemic inflammatory response in hospitalized patients with COVID-19. This study has been reviewed and approved by the Ethics Committee of the State University of Campinas (CAAE: 50440921.6.0000.5404).
Study Population Forty patients with a confirmed diagnosis of COVID-19 will be enrolled in the study. The patients will be identified as those admitted to either Hospital Estadual Sumaré (Sumaré, Brazil) and Unicamp Clinical Hospital (Campinas, Brazil). After enrolment, patients will be randomized (n=20 per group) in a 1:1 fashion to receive either diacerein 50mg or placebo treatment every 12 hours for 10 days.
Recruitment All patients admitted with COVID-19 who meet the inclusion and exclusion criteria will be invited to participate in the study. After reading and signing the informed consent form, the patient will be randomly allocated to two treatment arms.
Randomization and Blinding After enrolment, patients will be randomized (n=20 per group) 1:1 to receive either diacerein 50 mg or placebo treatment every 12 hours for 10 days. The research electronic data capture (REDCap) platform will be used as a randomization system. Patients, investigators and other support staff will be blinded to the experimental therapy. The study drug, diacerein (Artrodar®-capsules 50mg) and placebo capsules (lactose and magnesium stearate), will be similar in size and appearance to maintain blinding. All laboratory analyses will be performed blinded to the treatment. Identification of the study drug will only occur after locking the dataset.
Trial Intervention After randomization, patients allocated to the active treatment will receive 1 capsule of diacerein (Artrodar®, 50mg) orally every 12 hours for 10 days. Patients randomized to the placebo group will receive 1 capsule (lactose and magnesium stearate) orally every 12 hours for 10 days. There will be a dose adjustment of study medication (diacerein or placebo) to 1 capsule every 24 hours (decreased diacerein to 50 mg every 24 hours instead of every 12 hours) in participants who experience acute kidney injury with a rate of estimated glomerular filtration rate <30mL/min or requiring renal replacement therapy. If renal replacement therapy is required, the study drug will be administered immediately after dialysis.
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)
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
- •Adult patients of either sex (≥18 years of age) with a diagnosis of COVID-19 infection, confirmed by positive polymerase chain reaction PCR reaction.
- •Patient or his/her legal representative provide written informed consent prior to the start of the study.
排除标准
- •Patients already hospitalized and on mechanical ventilation for over 48 hours;
- •Pregnant or breastfeeding women;
- •Contraindication for the use of diacerein or history of diacerein hypersensitivity;
- •End-stage renal disease requiring renal replacement therapy;
- •Chronic liver disease and/or ALT and AST ≥5 times the normal upper reference limit;
- •Any active underlying malignancy;
- •Currently enrolled in another research study;
- •Peripheral capillary oxygen saturation/fraction of inspired oxygen ratio <100;
- •Use of high dose of >1.0 mcg/kg/min of norepinephrine or need for rescue therapy with vasopressin;
- •Bacterial or fungal infection, except for mild cutaneous infection or sinus infection.
- •Any condition which, in the opinion of the Investigator, places the patient at unacceptable risk if they were to participate in the study;
- •Clinically relevant serious co-morbid medical conditions including, but not limited to, unstable angina, symptomatic congestive heart failure, uncontrolled hypertension, uncontrolled cardiac arrhythmias, severe hepatic impairment, active central nervous system (CNS) disease uncontrolled by standard of care, known positive status for human immunodeficiency virus (HIV), active hepatitis B or C, cirrhosis, or psychiatric illness/social situations that would limit compliance with study requirements;
- •Treatment with any immunosuppressive therapy other than corticosteroids within 30 days prior to Screening;
研究组 & 干预措施
GROUP B
placebo capsules (lactose and magnesium stearate)
干预措施: placebo capsules (Drug)
GROUP A
diacerein 50 mg (capsules) every 12 hours for 10 days
干预措施: Diacerein (Drug)
结局指标
主要结局
Serum levels of cytokines, troponin-T and D-dimer
时间窗: Day 0, Day 2, Day 5, Day 10
The endpoints are the change in the serum levels of cytokines, troponin-T and D-dimer from Day 0 to Day 5 of hospitalization, and from Day 0 to Day 10, as well as the area under the curve considering all measurements from Day 0 to Day 10.
次要结局
- Time to clinical deterioration(Day 0 to Day 10)
- Adverse events(Day 0 to Day 10)
- Severe adverse events(Day 0 to Day 10)
研究者
Andrei Carvalho Sposito
Director, Brazilian Heart Study Group
University of Campinas, Brazil