COVID-19 Wave II Study for Assessing the Early Use of Hyperimmune Plasma for the Treatment of COVID-19 Patients Needing Non-invasive or Invasive Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Clinical improvement (efficacy)
研究概览
简要总结
The study assesses the efficacy of early administration of hyperimmune plasma in covid-19 patients who are on CPAP or intubated. Efficacy is measured as a 2 point decrease in the WHO scale
详细描述
Patients who satisfy eligibility criteria and in particular have started positive pressure respiratory support not more than no more than 48 hours are administered 200 to 300 ml in 2 or 3 times administered over a time window of 5 days. . Plasma titration will depend on the availability in the local Plasma Bank; any titre ≥ 1:80 will be acceptable. primary endpoint will be assessed at 28 days; vital status will be further investigated at 3 and 6 months.
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
- •Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or representatives will be obtained as soon as possible.
- •Male or female adult patient ≥18 years of age at time of enrolment.
- •Laboratory-confirmed SARS-CoV-2 infection as determined by real-time RT-PCR in naso/oropharyngeal swabs or any other relevant specimen..
- •Patient is hospitalized for COVID-19, is severely hypoxic with a P/F ≤ 200 while breathing room air or supplemental oxygen and requires positive pressure respiratory support, either non-invasive (helmet/mask CPAP or NIV) or invasive (endotracheal intubation and mechanical ventilation)
- •No more than 48 hours between the onset of positive pressure respiratory support and treatment administration day
- •Evidence of pulmonary infiltrates at chest imaging (chest x-ray, CT scan or LUS)
- •The patient is not eligible in the Tsunami trial.
排除标准
- •Participation in any other clinical trial of an experimental treatment for COVID-
- •In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments.
- •Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30).
- •Current documented and uncontrolled bacterial infection.
研究组 & 干预措施
Single
hyperimmune plasma with titre 1:80 or more
干预措施: hyperimmune plasma (Other)
结局指标
主要结局
Clinical improvement (efficacy)
时间窗: 28 days
Clinical improvement is obtained when a patient decreases his/her score by 2 points on the ten-category ordinal WHO scale or is discharged alive from the hospital, whichever comes first. The WHO scale is chosen in accordance with the "Clinical Characterisation and Management Working Group of the WHO Research and Development Blueprint programme" recently published in Lancet Infectious Diseases (WHO, 2020).
次要结局
- ecmo(28 days)
- hospitalization(28 days)
- WHO (World Health Organization) scale(From day 0 to 28 days)
- P/F(Days: from 0 to 7, 14 and 28)
- thrombosis(Days: from 0 to 7, 14 and 28)
- C-reactive protein(Days: from 0 to 7, 14 and 28)
- ventilation(Days: from 0 to 7, 14 and 28)
- SOFA (Sequential Organ Failure Assessment) score(Days: from 0 to 7, 14 and 28)
- naso-pharyngeal swab(Days: from 0 to 7, 14 and 28)
- Ferritin(Days: from 0 to 7, 14 and 28)
- Lung Function tests(6 months)
- High resolution computed tomography (HRCT)(6 months)
- Lymphocytes(Days: from 0 to 7, 14 and 28)
- SARS-CoV2(28 days)
- complication kidney(Days: from 0 to 7, 14 and 28)
- complication lung(Days: from 0 to 7, 14 and 28)
- Leucocytes(Days: from 0 to 7, 14 and 28)
- curarization(Days: from 0 to 7, 14 and 28)
- D-dimer(Days: from 0 to 7, 14 and 28)
- Troponin I (TnI)(Days: from 0 to 7, 14 and 28)
- PCTI (Procalcitonin) (ng/mL)(Days: from 0 to 7, 14 and 28)
- Albumin(Days: from 0 to 7, 14 and 28)
- Lung Ultrasound Score (LUS)(Days: from 0 to 7, 14 , 28 and 6 months)
- death(28 days, 3 and 6 months)
- LDH(Days: from 0 to 7, 14 and 28)
- Improvement mortality(28 days)
研究者
Catherine Klersy
Study Statistician
Fondazione IRCCS Policlinico San Matteo di Pavia