PHASE II Clinical Trial Randomized And Controlled To Assess Need Of Oxygen On Day 14 After Administration Of Passive Immunotherapy In Patients Infected By SARS-CoV-2 With Risks Factors For Severe Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Requirement for oxygen therapy to maintain saturation >93%
研究概览
简要总结
Plasma from convalescent individuals (convalescent plasma, CP) has been used for more than a hundred years for the treatment of infectious diseases. Among patients with COVID-19, it has been used first, in patients with severe infection. Although it is a safe treatment, it has not been possible to demonstrate a reduction in mortality in cases of acute respiratory distress syndrome.
The objective of the clinical trial is to evaluate the efficacy and safety of the early use (less than 5 days of symptoms) of CP in patients infected with SARS-CoV-2 with risk factors for severe disease.
The primary efficacy endpoint was the proportion of patients requiring oxygen therapy to maintain saturation >93% on day 14. Secondary objectives included, evaluation of the safety of the treatment, measured as the appearance of some adverse event related to the CP infusion; the evolution of COVID-19 symptoms and WHO progression scale status at day 14 and 28 after inclusion; the need for hospitalization due to progression of COVID-19. COVID-19 progression was considered as worsening of respiratory symptoms requiring oxygen therapy at some point. Finally, death from any cause was evaluated at 28 days, after inclusion in the study.
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
- •Patients with SARS-CoV-2 infection, confirmed by any validated microbiological technique, and with one or more symptoms associated with COVID-19 with ≤5 days of evolution and with an oxygen saturation ≥93% breathing room air.
- •In addition, the patients had to present some risk factor for severe disease:
- •Chronic heart failure (NYHA ≥ 2)
- •Arterial hypertension under pharmacological treatment
- •Chronic lung disease: COPD (bronchitis, emphysema or chronic obstruction) with dyspnoea at least on moderate exertion, or moderate-severe asthma (that required inhaled corticosteroids to control symptoms or had received systemic corticosteroids during the last year due to decompensation)
- •Chronic renal failure (glomerular filtration rate <60 ml/min/1.73 m², by CKD- ILD)
- •Diabetes mellitus requiring pharmacological treatment or obesity grade ≥ I (BMI ≥30 Kg/m2).
- •Patients ≥65 years were included, regardless of other risk factors.
排除标准
- •Duration of symptoms >5 days
- •Dyspnoea at rest
- •Need for supplemental oxygen to maintain O2 saturation >93%
- •Solid neoplastic or haematologic disease (except skin cancer) with active treatment in the last 3 months before the onset of symptoms
- •Patients under chronic corticosteroid treatment (equivalent to prednisone 10 mg/d for at least 28 days) or immunosuppressive treatment
- •Decompensated liver cirrhosis
- •Participation in another clinical trial
- •History of hypersensitivity to haematological derivatives
- •Pregnancy or lactation,
- •AST/ALT >5 times the upper limit of normal or at baseline in patients with chronic liver disease
- •Any condition that in the opinion of the investigator limits participation in the study.
- •Patients who had received monoclonal antibodies against SARS-CoV-2
结局指标
主要结局
Requirement for oxygen therapy to maintain saturation >93%
时间窗: Day 14
Proportion of patients that need oxygen to achieve a saturation \>93%
次要结局
- Safety of the treatment with CP(Day 1)
- Evolution of COVID-19 symptoms(Day 14 and 28)
- Requirement for hospitalization due to worsening of symptoms(Until day 28)