CTRI/2020/04/024706已完成2 期
Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients: A Pilot Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
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
- •Severe COVID -19 infections defined as WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria-
- •1.Respiratory distress, RR >=30 beats/min
- •2.Oxygen saturation level less than 93% in resting state
- •3.Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) <= 300 mmHg.
- •4.Lung infiltrates > 50% within 24 to 48 hours
- •5. Very sick (on ventilator) and patients with co-morbidities such as patients with known co-
- •morbid diseases (COPD, CAD, CLD, CKD, cardiopulmonary disease-structural or valvular heart
- •6. Patient presenting with multi organ failure or requiring mechanical ventilation.
- •7. Minimum age: 18 yrs to maximum age- no limit as per recent protocol amendment.
- •Known case of recovered COVID-19 Infection, and
- •Complete resolution of symptoms at least 28 days prior to donation or
- •Complete resolution of symptoms at least 14 days prior to donation and negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from the blood,
- •Negative RT-PCR for COVID-19 on two sequential paired nasopharyngeal and throat specimens > 24 hrs apart (WHO-CDC guideline).
- •Donor Plasma after 2 negative tests and 2 weeks of remaining asymptomatic, without antibody titre & presence of IgG/IgM antibodies to COVID-19 by serological as per manufacturers instructions. Donors negative for these will be deferred).
- •Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020.
排除标准
- •Patients with age less than 18 years.
- •Pregnancy
- •Individual with HIV and Hepatitis
- •Morbid Obesity BMI >35 kg/m2
- •Extremely moribund patients with an expected life expectancy of less than
- •Failure to give informed consent from the patient or family members.
- •Hemodynamic instability requiring vasopressors.
- •Previous allergic history to plasma.
- •Donors age < 18 and >=60 years old
- •Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under
- •the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020.
- •Females who have been pregnant and previously transfused donors (to
- •prevent TRALI).
- •Donors who have taken steroids during treatment for COVID-19.
研究者
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