Safety and Therapeutic Efficacy of Cyclosporine Plus Standard of Care Treatment on ARDS in COVID -19 Patients at Alexandria University Hospitals in 2021: a Comparative Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Percentage of subjects with a 6-point ordinal scale showing each severity level
研究概览
简要总结
The study to evaluate the effect of cyclosporine ( IL2 inhibitor and antiviral) verse standard care treatment on decrease ADRS, hyper inflammation, hypercytokinemia, and the mortality rate
详细描述
To test the efficacy of IL-2 inhibitors (Cyclosporine) compared to the Standard of care according to hospital protocol on COVID-19 patients concerning the clinical outcome (cytokines level, clinical improvement, and PCR of SARS-CoV-2 through the study period).
AIM:
The slow progression of the disease, improving survival among COVID-19 patients, and Standard assessment of patient improvement.
- Standard assessment of patient improvement:
- PCR-SARS-CoV-2 negative
- No fever
- No cytopenia (Hb ≥90 g/L, ANC ≥0.5x109/L, platelets ≥100x109/L) •
- No hyperferritinemia ≥500 μg/L
- (Decrease of IL2)
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current infection with COVID-19
- •written informed consent
- •Confirmed diagnosis of COVID-19 by PCR (polymerase chain reaction) tests and/or Positive Serology or any existing and validated diagnostic COVID-19 parameters during this time.
- •18yrs ≥ Age <66 yrs
- •Chest X-ray showing suggestive of COVID-19 disease.
- •Both gender
- •The presence of Pulmonary fibrosis or hyper inflammation signs or A syndrome of cytokine release defined as any of the following::
- •Leukopenia or lymphopenia,
- •Ferritin > 500ng/mL or D-dimers ≥ 500 ng/mL
排除标准
- •Lactation and Pregnancy women
- •unlikely to survive beyond 48h
- •Need for mechanical ventilation.
- •cases of multiorgan failure or abnormal renal function and shock.
- •malignancies, autoimmune disease, Perforation of the bowels or diverticulitis.
- •active bacterial or fungal infection.
- •We define impairment of cardiac function as poorly controlled heart diseases, cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia needs treatment or intervention, Uncontrolled hypertension (>180/110 mmHg.
- •Levels of serum transaminase >5 upper references rang
- •Symptoms of active tuberculosis or human immunodeficiency virus (HIV) positivity
- •the patient receiving Vaccines: Live, attenuated vaccines
- •Subjects received monoclonal antibodies within one week before admission.
- •Patients receiving high-dose systemic steroids (> 20 mg methylprednisolone or equivalent), immunosuppressant or immunomodulatory drugs
- •Contraindications for use in people with psoriasis include concomitant treatment with methotrexate, other immunosuppressant agents, coal tar, or radiation therapy.
研究组 & 干预措施
cyclosporine
patients will receive cyclosporine + (standard care treatment (± anticoagulant± antibiotic± antipyretic± steroid) according to Alexandria university hospitals protocol )
干预措施: cyclosporine (Drug)
Standard of care treatment
patients will receive standard treatment (antiviral ± anticoagulant± antibiotic± antipyretic± steroid± interleukin ) according to Alexandria university hospitals protocol.
干预措施: cyclosporine (Drug)
结局指标
主要结局
Percentage of subjects with a 6-point ordinal scale showing each severity level
时间窗: 7-14 days after randomization
i. Death ii. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation iii. Hospitalized, on non-invasive ventilation or high flow oxygen devices iv. Hospitalized, requiring supplemental oxygen v. Hospitalized, not requiring supplemental oxygen vi. Not hospitalized
次要结局
- all-cause mortality will be measured.(At 28, 30, and 90 days,)
- Incidence of (Adverse Events) and Incidence of nosocomial bacterial or invasive fungal infection(during hospital admission (up to 28 days)])
- Rate of decline OF Soluble interleukin-2 (IL-2) receptor alpha. (sCD25)(Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks))
- Rate of decline OF interleukin-1(Days 1, 8, 15 or at hospital discharge(through study completion, an average of 6 weeks))
- Rate of decline OF Interleukin-6,( IL-6)(Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks))
- Rate of decline OF Tumour necrosis factor α (TNFα)(Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks))
- Time to improvement in oxygenation(up to 28 days) from hospitalization)
- Mean change of SOFA score in ICU patients(between 1, 15 days) hospital discharge)
- Duration of hospital admission(through study completion, an average of 4 weeks)
- Rate of decline OF interleukin-10(IL-10)(Days 1, 8, 15 or at hospital discharge(through study completion, an average of 4 weeks))
- Time to 50% a decrease of ferritin levels compared to peak value during trial(up to 28 days)
- Number of days safe from ventilators(during hospital admission (up to 28 days))
- Number of days in the intensive care unit after randomization(during hospital admission (up to 28 days)])
- Lung imaging improvement time(up to 28 days)
- Time for non-invasive or invasive initial use(during hospital admission (up to 28 days)])
- Number of days on mechanical ventilation(during hospital admission (up to 28 days))
- Mean improvement in Clinical Deterioration Changed Early Warning Score (MEWS) between 1, 15 days)(between 1, 15 days) hospital discharge)
- rate of Mortality(throughout 30 and 90 days)