CTRI/2020/06/025803已完成3 期
Efficacy of Convalescent Plasma Therapy in Patients With COVID-19: A Randomized Control Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Recipient Inclusion Criteria:
- •- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-
- •Patients on ventilator (in last 24 hours)
- •Respiratory distress, RR greater than or equal to 30 beats/min
- •Oxygen saturation level less than 90 % in resting state
- •Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg
- •Lung infiltrates > 50% within 24 to 48 hours
- •Donor Inclusion Criteria for Plasmapheresis
- •Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days.
- •Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart.
- •Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- •Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.
排除标准
- •Recipient Exclusion Criteria:
- •Patient/ family members who do not give consent to participate in the study.
- •Patients with age less than 18 years
- •Patients presenting with multi-organ failure
- •Individuals with HIV and Viral Hepatitis and Cancer
- •Extremely moribund patients with an expected life expectancy of less than 24 hours
- •Hemodynamic instability requiring vasopressors
- •Previous history of allergy to plasma
- •Severe renal impairment with GFR < 30ml/min or recipients of RRT, peritoneal dialysis
- •Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable Angina
- •Donors Exclusion Criteria:
- •Do not fulfill all criteria of donor eligibility for donor Plasmapheresis under
- •the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020
- •Females who have been pregnant and have not been tested for HLA antibodies or are HLA antibody positive if tested and previously transfused donors (to prevent TRALI)
- •Donors who have taken steroids during treatment for COVID-19
研究者
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