Phase I Trial for the Prevention of Cytokine Release Syndrome (CRS) With Cyclosporine in Patients With Moderate COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Safety-changes in absolute lymphocyte count
研究概览
简要总结
Phase 1 safety study to determine the tolerability, clinical effects, and changes in laboratory parameters of short course oral or IV cyclosporine (CSA) administration in patients with COVID-19 disease requiring oxygen supplementation but not requiring ventilator support.
详细描述
Our overall hypothesis is that CSA is safe in this patient population and that it will have antiviral and anti-cytokine effects as measured in laboratory tests.
The initial dose will be 9 mg/kg/day oral divided q12h or 3 mg/kg/day by continuous IV infusion. Oral administration is generally preferred, however IV administration can be used if oral administration is not feasible or cannot be tolerated, or at the physician-investigator's clinical discretion. The dose will be adjusted to target a trough level of 200 to 300 ng/ml, which is in alignment with common clinical practice. The planned duration of CSA treatment is up to 14 days, with planned discontinuation upon discharge from the hospital. Dose reduction of 25% to 50% can be made for patients who experience adverse events such as hypertension or serum creatinine elevation.
The end of study will be study day 30 for those patients who have been discharged from the hospital. If the patient remains in the hospital, the subject will still complete the end of study visit at day 30 as planned, but will continue to be followed until date of discharge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged >
- •Admitted to hospital with laboratory confirmation of SARS-CoV-2 infection.
- •Estimated creatinine clearance >50 ml/min using standard Cockcroft-Gault formula.
排除标准
- •Are admitted to the ICU at time of enrollment.
- •Have an active uncontrolled infection with a non-COVID-19 agent.
- •Have an active malignancy, not including non-melanoma skin cancer, superficial cervical or bladder cancer, MGUS, or prostate cancer with PSA <1.
- •Are on chronic immune suppressive medications, including
- •corticosteroid therapy at a prednisone equivalent dose of 10 mg per day or higher; therapy with calcineurin inhibitors or mTOR inhibitors.
- •Are pregnant
- •Are lactating
- •Have a known allergic reaction to components of the CSA or its diluents.
- •Are receiving investigational vaccine for SARS-CoV-2.
研究组 & 干预措施
Single Arm
Cyclosporine; oral or IV route of administration, per investigator discretion. Duration of administration up to 14 days, as tolerated.
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Safety-changes in absolute lymphocyte count
时间窗: 3 months
Safety will be assessed: By monitoring changes in absolute lymphocyte counts
Safety-changes in creatinine clearance
时间窗: 3 months
Safety will be assessed: By monitoring changes in creatinine clearance. Creatinine clearance will be estimated using the Cockcroft-Gault formula.
Safety-secondary bacterial infections
时间窗: 3 months
Safety will be assessed: By monitoring the incidence of secondary bacterial infections complicating COVID-19 hospitalization
Safety-oxygen, ICU transfer and ventilation
时间窗: 3 months
Safety will be measured: By assessing the proportion of participants requiring increase in oxygen requirements, transfer to intensive care unit, and/or mechanical ventilation
次要结局
- Laboratory measurements-ferritin(3 months)
- Laboratory measurements- IL-6(3 months)
- Laboratory measurements of safety and antiviral efficacy related to COVID-19-SARS-CoV-2 by measuring the clearance of SARS-CoV-2 from respiratory secretions(3 months)
- Laboratory measurements-D-dimer levels(3 months)