To Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications - COVID PLASMA STUDY

Apollo Hospitals Enterprise Limited0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1. Tested positive for COVID 19 by RT-PCR
•2. Age > 18 years
•3. Written and informed consent
•4. Severe or Life threatening disease.
•1. Severe disease is defined as: (one or more are present)
•i. Dyspnea with oxygen saturation <= 93%,
•ii. Respiratory frequency >= 30/min and oxygen saturation <= 93%,
•iii.Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300
•iv.Infiltrates on chest X-ray > 50% within 24 to 48 hours
•2. Life-threatening disease is defined as: (one or more are present)
•i. Respiratory failure needing invasive support
•ii. Sepsis,
•iii. Multiple organ dysfunction or failure

•1. Known hypersensitivity to blood products
•2. Receipt of Pooled Immunoglobulin in last 30 days
•3. Participating in any other clinical trial
•4. Contraindications to blood products
•5. Pregnant or Breast feeding women
•6. In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours.
•7.On mechanical ventilation for more than 7 days
•8.Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g. stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.)
•9. Respiratory failure caused by illness other than SARS-CoV-2.
•10 . Other documented uncontrolled infection
•11. Severe DIC,TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate.
•12. Active intracranial bleeding.
•13. Clinically significant myocardial ischemia.

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