An Investigator Initiated, International Multi-Centre, Multi-Arm, Multi-Stage Randomised Double Blind Placebo Controlled Trial of Angiotensin Receptor Blocker (ARB) & Chemokine Receptor Type 2 (CCR2) Antagonist for the Treatment of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 49
- 试验地点
- 10
- 主要终点
- Clinical Health Score at day 14
研究概览
简要总结
CLARITY 2.0 is an investigator-initiated trial that will evaluate the safety and efficacy of dual treatment with repagermanium, a CCR2 antagonist, and candesartan, an ARB, in patients hospitalised with COVID-19 disease.
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
- •Adults aged ≥ 18 years (maximum 65 years old in India).
- •Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation. (Confirmation must be through Reverse Transcription Polymerase Chain Reaction [RT-PCR] method)
- •Intended for hospital admission for management of COVID-
- •Patients with moderate (respiratory rate of ≥ 24/minute or SPO2: 90% to ≤ 93% on room air) or severe (respiratory rate of ≥ 30/minute or SPO2: <90% on room air) COVID-
- •Systolic Blood Pressure (SBP) ≥ 120 mmHg OR SBP ≥ 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased.
- •Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- •Documented informed consent.
排除标准
- •Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi
- •Intolerance of ARBs
- •Serum potassium >5.5 mmol/L
- •An estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.732m
- •Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15)
- •Pregnancy, lactation, or inadequate contraception.
- •Participation in a study of a novel investigational product within 28 days prior to randomisation.
- •Plans to participate in another study of a novel investigational product during this study.
研究组 & 干预措施
Control Arm #1
Titratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
干预措施: Candesartan Cilexetil (Drug)
Interventional Arm
Titratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + fixed dose repagermanium one x 120mg immediate release capsule twice daily (total daily dose 240mg). Treatment will continue for 28 days.
干预措施: Candesartan Cilexetil (Drug)
Interventional Arm
Titratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + fixed dose repagermanium one x 120mg immediate release capsule twice daily (total daily dose 240mg). Treatment will continue for 28 days.
干预措施: Repagermanium (Drug)
Control Arm #1
Titratable candesartan with commencing dose 4mg tablets twice daily (daily dose 8 mg) + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
干预措施: Repagermanium Placebo (Drug)
Control Arm #2
Titratable matched placebo candesartan one tablet twice daily + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
干预措施: Candesartan Placebo (Drug)
Control Arm #2
Titratable matched placebo candesartan one tablet twice daily + matched placebo repagermanium one capsule twice daily. Treatment will continue for 28 days.
干预措施: Repagermanium Placebo (Drug)
结局指标
主要结局
Clinical Health Score at day 14
时间窗: 14 days
The primary objective is to evaluate the safety and efficacy of dual treatment with repagermanium and candesartan in patients hospitalised with COVID-19 disease, assessed by the Clinical Health Score at day 14, which is determined within an 8-point ordinal scale of health status: 1. Not hospitalised, no limitations on activities. 2. Not hospitalised, limitation on activities. 3. Hospitalised, not requiring supplemental oxygen. 4. Hospitalised, requiring supplemental oxygen by mask or nasal prongs. 5. Hospitalised, on non-invasive ventilation or high-flow oxygen devices. 6. Hospitalised, requiring intubation and mechanical ventilation. 7. Hospitalised, on invasive mechanical ventilation and additional organ support (ECMO). 8. Death.
次要结局
- Death(28 days)
- Clinical Health Score at day 28(28 days)
- Time to death(28 days)
- ICU admission(28 days)
- Requirement of dialysis(28 days)
- Clinical Health Score at day 90(90 days)
- Acute Kidney Injury(28 days)
- Length of hospital admission(28 days)
- Length of ICU Admission(28 days)
- Requirement of ventilatory support(28 days)
- Clinical Health Score at day 180(180 days)
- Respiratory Failure(28 days)
- Clinical Health Score at day 60(60 days)