Early Convalescent Plasma Therapy for High-risk Patients With COVID-19 in Primary Care (the CoV-Early Study)
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 420
- 试验地点
- 12
- 主要终点
- Highest disease status
研究概览
简要总结
An effective, widely available, and safe treatment that can decrease the duration, severity and fatality of COVID-19 is urgently needed. Also, in the most affected regions the pressure on health care systems including ventilator support capacity can be a limiting factor for survival. Initial studies including from our group indicate that administering convalescent plasma containing high titers of neutralizing antibodies to COVID-19 patients who are already relatively late during the disease course after hospital admission is not effective, which can be explained by high titers of autologous antibodies present in patients. Thus, the antiviral capacity of convalescent plasma is hypothesized to be best positioned early in the disease course and in patients at increased risk for a severe disease course. If effective, any treatment that decreases the need for hospital admission is very valuable but so far, no COVID-19 treatment has been shown to prevent clinical deterioration when given before patients are admitted to the hospital.
Primary objective:
To evaluate the efficacy, feasibility and safety following the administration of convalescent plasma (ConvP) as a therapy for outpatients diagnosed with COVID-19 at increased risk for an unfavourable clinical outcome and within 7 days after symptom onset.
Study design:
This trial is a nationwide multicenter, double blind, randomized controlled trial in the Netherlands. Patients will be randomized between the transfusion of 300mL of convP versus regular fresh frozen plasma (FFP).
Patient population:
Patients with polymerase chain reaction (PCR) confirmed COVID disease with less than 8 days of symptoms, age 70 or older or 50-69 years with at least 1 additional risk factor for severe COVID-19 are eligible.
Intervention:
300mL of convP with a minimum level of neutralizing antibodies.
A total of 690 patients will be included. Expected duration of accrual: 18-24 months Duration of follow up :Day 28 for the primary endpoint
详细描述
Secondary (exploratory) objectives
- To evaluate the impact of 300mL convP on mortality
- To evaluate the impact of 300mL convP on hospital admission
- To evaluate the impact of 300mL convP on admission to ICU
- To evaluate the impact of 300mL convP on duration of symptoms
- To evaluate the impact of 300mL convP in relation to the age and clinical frailty of the patient
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RT-PCR-confirmed COVID-
- •Symptomatic (e.g but not limited to fatigue, fever, cough, dyspnoea, loss of taste or smell, diarrhea, falls or confusion)
- •70 years or older OR 50-69 years and 1 or more of the risk factors described in the protocol
排除标准
- •Life expectancy <28 days in the opinion of the treating physician
- •Patient or legal representative is unable to provide written informed consent
- •Symptomatic for 8 days or more
- •Being admitted to the hospital at the informed consent procedure
- •Known previous history of transfusion-related acute lung injury
- •Known Immunoglobulin A (IgA) deficiency
结局指标
主要结局
Highest disease status
时间窗: 28 days following transfusion of convP or FFP
Highest disease status on the 5-point ordinal disease severity scale in the convP group will be compared with the FFP group.
次要结局
- Disease duration in days of symptoms(28 days following transfusion of convP or FFP)
- Percentage of deaths(28 days following transfusion of convP or FFP)
- Percentage of hospital admissions(28 days following transfusion of convP or FFP)
- Percentage of ICU admissions(28 days following transfusion of convP or FFP)
- Age and clinical frailty score(28 days following transfusion of convP or FFP)
研究者
Bart Rijnders
MD, PhD
Erasmus Medical Center