COVID-19 Convalescent Plasma Treatment in SARS-CoV-2 Infected Patients: Multicenter Interventional Study
试验速览
- 阶段
- 1 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Time to clinical improvement
研究概览
简要总结
Due to the limitations of COVID-19 treatment and in the absence of licensed antiviral for COVID-19, the historical choice of therapeutic convalescent plasma (CP) is considered especially against RNA viruses .It was known that convalescent plasma does not only neutralize the pathogens but provide passive immunomodulatory properties that allows the recipient to control the exaggerated inflammatory cascade. However, still there is a lack of understanding of the mechanism of action of CCP therapeutic components. Reports from open label trials and case series show that CCP is safe and might be effective in severe cases with COVID-19 . Therefore, the World health organisation (WHO) and Food and Drug Administration (FDA) issued guidelines for the CCP usage and standardised the donor selection , which was further supported by Emergency use Authorisation (EUA) .
Therefore, the aim in the current study is to assess the effect of CCP on time to clinical improvement, hospital mortality and to evaluate the changes on oxygen saturation and laboratory markers (lymphocyte counts and C-reactive protein) compared with standard treatment alone in patients with moderate or severe COVID-19 disease.
详细描述
This is a prospective multicenter interventional observational study will be conducted in 4 major tertiary hospitals (Al-Sabah, Farwaniya , Mubarak Al-Kabeer and Jahra) in Kuwait .
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥18 years old ( those who are younger are involved after case based discussion)
- •Confirmed laboratory diagnosis with SARS-CoV-2 ,and admission diagnosis of SARS-CoV-
- •Patients with moderate or severe COVID-19 (moderate COVID-19 disease defined as the presence of any signs of pneumonia (fever, cough, dyspnoea fast breathing) including SpO2 >90 on room air , but no signs of severe pneumonia (severe pneumonia have the above plus one of the following: respiratory rates >30 breaths/minutes or SpO2<90% on room air), or admission to intensive care unit (ICU) for respiratory support (i.e.high flow nasal cannula, non-invasive mechanical ventilation and intubation).
排除标准
- •Contraindication to transfusion (volume overload, history of anaphylaxis to blood products).
- •Patients presenting with acute severe multiorgan failure, hemodynamic instability.
- •3- Severe disseminated coagulopathy (DIC), septic shock and those with expected survival of less than 48 hours.
研究组 & 干预措施
CCP patients
- Patient has to fulfil the inclusion/exclusion criteria of the ward or the ICU
- Valid consent.
- Request the CCP from the central blood bank (200-250 ml/dose - can be repeated again in 12 hours) this is through the local hospital blood bank.
How to transfuse CCP:
- Dose required is 200-250 ml/hr (one dose, can be repeated in 12 hrs), max total 500ml.
- Premedication prior to administration of CCP (Acetaminophen, diphenhydramine,steriods) or according to hospital guidelines.
干预措施: COVID-19 Convalscent Plasma (Drug)
结局指标
主要结局
Time to clinical improvement
时间窗: 30 days
Time to clinical improvement is defined as a time frame from CCP administration till 30 days or discharge, defined as a 2-grade decrease on an ordinal WHO clinical scale . The WHO clinical scale based on the following 7-grade ordinal levels: 1= ambulatory, independent; 2= ambulatory with assistance; 3=hospitalised, not requiring supplemental oxygen; 4= hospitalised, requiring supplemental oxygen; 5= hospitalised, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6= hospitalised, requiring extracorporeal membrane oxygenation, invasive mechanical ventilation, or both; and 7= death.
次要结局
- All cause mortality(30 days)
研究者
Sondus AlSharidah
Sondus Alsharidah
Ministry of Health, Kuwait