Phase II, Randomized, Double-blind, Controlled Clinical Trial Evaluating the Efficacy and Safety of Plasma From Patients Cured of COVID-19 Compared to the Best Available Therapy in Subjects With SARS-CoV-2 Pneumonia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Early all-cause mortality
研究概览
简要总结
In early December 2019, cases of pneumonia of unknown origin were identified in Wuhan, China. The causative virus was called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The World Health Organization (WHO) has recently declared coronavirus disease 2019 (COVID-19) a public health emergency of international concern.
According to the World Health Organization (WHO), the management of COVID-19 has focused primarily on infection prevention, detection and patient monitoring. However, there is no vaccine or specific treatment for SARS-CoV-2 due to the lack of evidence. Treatment options currently include broad-spectrum antiviral drugs but the efficacy and safety of these drugs is still unknown.
Convalescent plasma has previously been used to treat various outbreaks of other respiratory infections; however, it has not been shown to be effective in all the diseases studied. Therefore, clinical trials are required to demonstrate its safety and efficacy in patients with VIDOC-19.
The present work seeks to determine the mortality from any cause up to 14 days after plasma randomization of patients cured of COVID-19 compared to the Best Available Therapy in subjects with SARS-CoV-2 pneumonia. This is a 2:1 randomized, double-blind, single-center, phase 2, controlled clinical trial (plasma: best available therapy) for the treatment of SARS-CoV-2 pneumonia.
详细描述
Randomized clinical trial comparing convalescent plasma to best available therapy (BAT) for the treatment of severely ill and critically ill patient with COVID-19: Patients will be electronically randomized 2:1 (plasma vs BAT) in a double blind fashion. Patients with SARS-CoV-2 PCR confirmed infection with pulmonary infiltrates and hypoxemia will be screened and invited to participate. Primary outcomes will be early all-cause mortality, and secondary outcomes will include all cause in hospital mortality, length of mechanical ventilation and hospital stay, time to PAO2 >200, progression of pulmonary infiltrates, antibody titers and time to negative PCR detection
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)
盲法说明
double blind
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
- •Men or women ≥18 years. If you are a woman of childbearing age, you must agree to practice abstinence or to use an effective method of contraception during the study period.
- •Vascular access suitable for administration of hemocomponents.
- •SARS-CoV-2 positive RT-PCR.
- •Negative pregnancy test in case of a woman of reproductive age
- •Signing of evidentiary document of informed consent.
- •Hospital admission for SARS-CoV-2 pneumonia with supplemental oxygen requirements.
- •Subjects who access the storage of biological samples for future examination.
排除标准
- •Respiratory rate >30 RPM, SO2 <93%, PaO2/FiO2 <200 despite intervention with oxygen therapy after 60 minutes of hospitalization.
- •New alteration of the state of alert that does not revert after interventions 60 minutes after admission to hospital.
- •PAM ≤ 65mmHg despite initial resuscitation on arrival at the centre.
- •Pregnant or breastfeeding patients.
- •Patients that the investigators consider inappropriate to participate in the clinical trial
- •Contraindication to transfusion or history of previous severe reaction to blood products.
- •Have received any blood products in the last 120 days.
结局指标
主要结局
Early all-cause mortality
时间窗: 14 days
any cause mortality during the first 14 days of treatment
次要结局
- Time in days for SARS-CoV-2 RT-PCR negatives(90 days)
- Detection of serum antibodies(days 0, 3, 7, 14 and 90.)
- The serum anti-SARS-CoV-2 antibody titres(90 days)
研究者
Dr. Adrian Camacho-Ortiz
Head of the Infectious Disease Department
Hospital Universitario Dr. Jose E. Gonzalez