Randomized Open Pilot Study to Evaluate the Efficacy of Subcutaneous Sarilumab in Patients With Moderate-severe COVID-19 Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
The global health emergency created by the rapid spread of the SARS-CoV-2 coronavirus has pushed healthcare services to face unprecedent challenges to properly manage COVID-19 severe and critical manifestations affecting a wide population in a short period of time. Clinicians are committed to do their best with a great uncertainty in this evolving crisis. Off label use of plenty of drugs has arisen the need for clinical trials to demonstrate their true role in the therapy. Based in unpublished experiences in China, Italy and Spain, intravenous IL-6 receptor inhibitors are now being tested in several trials but no data on subcutaneous formulations are available yet. Sarilumab is a human monoclonal antibody that binds membrane-bound and soluble IL-6 receptors to inhibit IL-6 signalling, licensed in a subcutaneous route administration.
详细描述
SARCOVID is an investigator-initiated monocentric randomised proof of concept study that aims to evaluate the efficacy and safety of a single dose of sarilumab, in subcutaneous administration, in hospitalised patients with moderate to early severe COVID-19 infection, compared to the current standard of care.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age> 18 years
- •Laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other validated commercial or public health assay
- •Documented interstitial pneumonia requiring admission and at least two of the following:
- •Fever ≥ 37.8ºC (tympanic)
- •IL-6 in serum ≥ 25 ng / mL (in the absence of a previous dose of prednisone or equivalent> 1 mg / kg) or PCR> 5mg / dL
- •Lymphocytes <600 mm3
- •Ferritin> 300 mcg / L that doubles in 24 hours
- •Ferritin> 600 mcg / L in the first determination and LDH> 250 U / L
- •D-dimer (> 1 mg / L)
- •Informed verbal or administration consent under urgent conditions, documented in the electronic medical record.
排除标准
- •Patients who require mechanical ventilation at the time of inclusion.
- •AST / ALT values > 5 folds upper normal limit.
- •Neutrophil count below 500 cells / mm3
- •Platelet count below 50,000 cells / mm3
- •Documented sepsis or high suspicion by pathogens other than COVID-
- •Presence of comorbidities that according to clinical judgment could lead to an unfavorable result.
- •Complicated diverticulitis or intestinal perforation.
- •Current skin infection (eg, uncontrolled dermopiodermitis).
- •Immunosuppressive anti-rejection therapy.
- •Pregnancy or lactation.
- •Previous treatment with tocilizumab or sarilumab.
- •Patients participating in some other clinical trial for SARS-CoV-2 infection.
- •Patients with known hypersensitivity or contraindication to sarilumab or excipients.
研究组 & 干预措施
Sarilumab plus standard of care
Sarilumab 200 mg, 2 sc injections in pre-filled syringe or pen, single dose. Treatment with drugs or procedures in routine clinical practice that the clinician responsible for the patient deems necessary is allowed
干预措施: Sarilumab (Drug)
Standard of care
Treatment with drugs or procedures in routine clinical practice
干预措施: Standar of care (Other)
结局指标
主要结局
Death
时间窗: 30 days from enrolment
Number of deaths
Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation
时间窗: 7 days from enrolment
Score ranges 1-7 1. Death; 2. Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen devices; 4. Hospitalized, requiring supplemental oxygen; 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7. Not hospitalized
Duration of hospitalisation (days)
时间窗: 30 days from enrolment
Days from the date of enrolment to the date of discharge
次要结局
- Mean change in clinical status assessment using the 7-point ordinal scale at day 14 after randomisation(14 days from enrolment)
- Time to non-invasive mechanical ventilation (days)(30 days from enrolment)
- Time to independence from supplementary oxygen therapy (days)(30 days from enrolment)
- Time to become afebrile (days)(30 days from enrolment)
- Time to invasive mechanical ventilation (days)(30 days from enrolment)
研究者
Maria del Rosario Garcia de Vicuña Pinedo
MD, PhD
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa