Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Clinical status on a 7-point ordinal scale
研究概览
简要总结
Plasma from donors who have recovered from coronavirus disease 2019 (COVID-19) contain antibodies to SARS-CoV-2 and may be a potential therapy for hospitalized patients with COVID-19. The efficacy of high-titer convalescent plasma for COVID-19, however, still unclear. The present study aims to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19.
详细描述
This is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19. Participants must be adult hospitalized patients with a confirmed diagnosis of COVID-19 and time Between symptom onset and inclusion ≤ 7 days. Two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 mL of high-titer COVID-19 convalescent plasma or standard care. The primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the World Health Organization. Safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. Study visits will occur on Day 1, Day 3, Day 7, and Day 14 or until hospital discharge, whichever comes first.
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
- •Hospitalized patients aged ≥18 years.
- •Confirmed diagnosis of COVID-19 by RT-PCR or antigen test in respiratory samples.
- •Time between symptom onset and inclusion ≤ 7 days.
- •Enrolled within 5 days of hospitalization.
- •Sign the consent form.
排除标准
- •Contraindication to transfusion due to inability to tolerate additional fluid, such as due to decompensated congestive heart failure.
- •History of previous severe allergic reactions to transfused blood products.
- •Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.
- •Not currently enrolled another interventional clinical trial of COVID-19 treatment.
- •Critically ill patient with COVID-19 being treated in intensive care.
研究组 & 干预措施
Convalescent Plasma
The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Centro de Hematologia e Hemoterapia do Paraná - Hemepar following national blood donation guidelines and Brazilian Health Regulatory Agency (ANVISA) criteria. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined. Participants will receive the standard of care treatment and a single unit of convalescent plasma (volume=200 mL or 400 mL).
干预措施: Convalescent plasma (Biological)
Standard of care
Standard of care treatment according to the institutional protocol.
干预措施: Standard of care (Drug)
结局指标
主要结局
Clinical status on a 7-point ordinal scale
时间窗: From randomization to end of study at Day 14
Patients' clinical status over time assessed by a 7-point ordinal scale from World Health Organization (WHO). Lower scores are seen with better clinical outcomes. The scale categories are as follows: (1), not hospitalized with resumption of normal activities; (2), not hospitalized, but unable to resume normal activities; (3), hospitalized, not requiring supplemental oxygen; (4), hospitalized, requiring supplemental oxygen; (5), hospitalized, requiring high-flow oxygen therapy or noninvasive mechanical ventilation; (6), hospitalized, requiring ECMO (extracorporeal membrane oxygenation), IMV (intermittent mandatory ventilation), or both; (7), death. Proportion of patients with clinical improvement, defined by an increase of two points in the ordinal scale of seven WHO categories.
次要结局
- Percentage of participants at each clinical status on a 7-point ordinal scale(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Oxygen saturation(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Respiratory rate(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Ventilator free days(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Time until independence from oxygen therapy in days(Day 1, Day 3, Day 7, and Day 14 after randomization)
- In patients who needed mechanical ventilation, time to initiate mechanical ventilation (calculated in days, from entry into the protocol until orotracheal intubation)(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Percentage of participants who develop serious adverse events and adverse events considered as definitely or probably associated with plasma transfusion(Daily, until Day 14 after randomization)
- The PaO2 / FiO2 ratio (for patients on mechanical mechanisms)(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Number and /or extension of affected lung areas on chest computed tomography(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Length of hospital stay(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Rate of transfusion reactions to convalescent plasma infusion(Daily, until Day 14 after randomization)
- Prevalence of oxygen-intake methods(Day 1, Day 3, Day 7, and Day 14 after randomization)
- Length of stay in intensive care(Day 1, Day 3, Day 7, and Day 14 after randomization)
研究者
Tânia Portella Costa
Tânia Portella Costa - Maternidade e Cirurgia Nossa Senhora do Rocio/ SA - Hospital do Rocio
Science Valley Research Institute