The Therapeutic Potential of Convalescent Plasma Therapy on Treating Critically-ill COVID-19 Patients Residing in Respiratory Care Units in Hospitals in Baghdad, Iraq
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Death versus survival of treated patients
研究概览
简要总结
Out of 49 early-stage critically-ill COVID-19 patients, 21 patients are the experimental group who take convalescent plasma compared to 28 patients receive only conventional therapy without taking Convalescent plasma. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease are monitored in relation to monitoring through severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) RNA detection via poly chain reaction (PCR), and SARS-CoV-2 immunoglobulin G (IgG) and immunoglobulin M (IgM) serological monitoring.
详细描述
Objectives: The current COVID-19 pandemic needs unconventional therapies to tackle the resulted high morbidity and mortality. Convalescent plasma is one of the therapeutic approaches that might be of benefit. Methods: Forty nine early-stage critically-ill COVID-19 patients residing in respiratory care units (RCU) of three hospitals in Baghdad, Iraq were included, 21 received convalescent plasma while 28 did not receive, namely control group. Recovery or death, length of stay in hospital, and improvement in the clinical course of the disease were monitored clinically along with laboratory monitoring through SARS-CoV-2 RNA detection via PCR, and SARS-CoV-2 IgG and IgM serological monitoring.
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
- •49 critically-ill COVID-19 patients are included.
- •All of the patients were with pneumonia and residing in RCU
- •Age ≥ 18 y
- •With dyspnea and oxygen saturation less than 90% in resting state.
- •At their first 3 days in RCU either receiving O2 therapy, c-pap, or on ventilators.
- •All of the patients were residing in infectious diseases wards before being transferred to RCU.
排除标准
- •The exclusion criteria of the COVID-19 patients were:
- •Previous allergic history to plasma or its ingredients such as sodium citrate.
- •Cases with serious general conditions, such as severe organ dysfunction, that are not suitable for transfusion.
- •Very late stage of the acute respiratory distress (ARDS) where Convalescent plasma (CP) has proved to be of low therapeutic benefit
研究组 & 干预措施
Convalescent plasma group
21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.
干预措施: Convalescent plasma (Biological)
Convalescent plasma group
21 critically-ill COVID-19 patients were given convalescent plasma: 400 ml of convalescent plasma from COVID-19 recovered subjects. The plasma infusion lasts for one hour.
干预措施: Hydroxychloroquin with Azithromycin (Drug)
Control group
This group is 28 critically-ill COVID-19 patients who are at the same disease stage to those of experimental group that were treated with conventional therapy without taking convalescent plasma.
The conventional therapy: 400 mg once PO Hydroxychloroquine/day with 250mg once PO Azithromycin.
干预措施: Hydroxychloroquin with Azithromycin (Drug)
结局指标
主要结局
Death versus survival of treated patients
时间窗: Up to 8 weeks
evaluate the role of convalescent plasma in saving life of treated patients by measuring the final outcome whether treated patients survived or died
次要结局
- The length of stay in hospitals(Up to 8 weeks)
研究者
Ahmed Sahib Abdulamir
Professor in Virology and infectious diseases
Alkarkh Health Directorate-Baghdad