Randomized Phase IIa Clinical Trial Of Cyclosporine For The Treatment Of COVID-19(+) Non-ICU Hospital Inpatients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- WHO(World Health Organization) COVID-19 Clinical Severity Scale
研究概览
简要总结
Phase IIa clinical trial in which 75 non-ICU hospital inpatients will be randomized 2:1 to 7 days of an oral formulation of cyclosporine, Neoral (2.5mg/kg PO BID) + standard of care (SOC) or no Neoral + SOC. The primary endpoint is disease severity based on the World Health Organization (WHO) COVID Ordinal Outcomes Scale, on day 14. Secondary endpoints include safety and changes in serum inflammatory markers.
详细描述
- OBJECTIVES
1.1 Primary Objectives
1.1.1 To assess the effect of a 7-day course of oral cyclosporine Neoral on clinical outcome using the World Health Organization (WHO) COVID Ordinal Clinical Outcomes Scale, on day 14.
1.2 Secondary Objectives
1.2.1 To establish the safety of Neoral in this patient population (adverse events).
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •3.1.1 Laboratory-confirmed SARS-CoV-2 infection within the past 10 days.
- •3.1.2 Patients admitted to non-ICU hospital floors or in an emergency department awaiting admission to a non-ICU hospital bed.
- •3.1.3 WHO COVID Scale Score 4 (Oxygen by mask or nasal prongs or WHO COVID Scale Score 5 (non-invasive ventilation or high-flow oxygen).
- •3.1.4 Age 18 to 90 years old.
- •3.1.5 ECOG (Eastern Cooperative Oncology Group) performance status ≤2 (see Appendix A).
- •3.1.6 Patients receiving or who have received standard of care therapy for COVID-19 can be included. This includes Remdesivir, Dexamethasone (or other steroids), and convalescent plasma.
- •3.1.7 Ability to understand and the willingness to sign a written informed consent document.
排除标准
- •3.2.1 Allergy and/or hypersensitivity to CSA.
- •3.2.2 GFR<30 mL/min.
- •3.2.3 ALT (Alanine transaminase) or AST (Aspartate transaminase) >3X upper limits of normal.
- •3.2.4 Resistant hypertension (BP>140/90 mm Hg despite adherence to maximal doses of three antihypertensive agents).
- •3.2.5 Active bacterial or mycobacterial infection.
- •3.2.6 Pregnant and/or nursing patients. 3.2.7 Participation in a COVID-19 therapeutic drug trial.
- •3.2.8 Patients who have received or who are receiving anti-viral medications including hydroxychloroquine will not be excluded.
- •3.2.9 Patients with psychiatric illness/social situations that would limit compliance with study requirements.
- •3.2.10 Total cholesterol is < 100 (increased risk of seizure)
- •3.2.11 Concomitant dosing with Tacrolimus is a relative contraindication (increases overall immunosuppression and decrease seizure threshold
- •3.2.12 Concomitant malignancy is a relative contraindication (Neoral can increase susceptibility to development of neoplasia)
- •3.2.13 Inability to swallow oral medication
- •3.2.14 Treatment with immunomodulators or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors.
- •3.2.15 Investigational Antiviral agents
研究组 & 干预措施
Arm A Cyclosporine
Neoral, N=50 Patients 2.5 mg/kg PO BID 7 days
干预措施: Cyclosporine (Drug)
Arm B Standard of Care
Standard of Care Treatment, N= 25 Patients 7 days
干预措施: Standard of Care Treatment (Other)
结局指标
主要结局
WHO(World Health Organization) COVID-19 Clinical Severity Scale
时间窗: on day 14
WHO(World Health Organization) COVID-19 clinical severity scale. Score 0-9. 0=Uninfected, 8=Death.
次要结局
未报告次要终点
研究者
Bryan Burt, MD
Associate Professor, Surgery General Thoracic
Baylor College of Medicine