Open Label, parallel arm, phase I/II clinical trial to evaluate Safety and efficacy of Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease

International Stemcell Services Ltd0 个研究点目标入组 24 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•18 years and older (male or female)
•-Laboratory confirmation of COVID â?? 19
•-CT image is characteristic of 2019 novel corona virus pneumonia (optional)
•-Sign a consent form and follow the test plan and follow-up process.
•Inclusion criteria for donors of plasma
•-18 years and older (male or female)
•-Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge.
•-COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors. The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample.
•-The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis).
•-Sign a consent form and follow the test plan and follow-up process.

•-Patients with autoimmune disease in the past or screening
•-Those who have serious disease that affect their overall survival as decided by the treating clinican
•-Self reports HIV or syphilis infected persons
•-Pregnant or lactating women
•-Continuous use of immunosuppressive agents or organ transplants in the past 6 months.
•Exclusion criteria for donors
•-Patients who become sick again after getting discharged
•-RNA positive for COVID or TTI positive.

发起方

International Stemcell Services Ltd