A Randomised Open-Label Trial of Early, Very High-Titre Convalescent Plasma Therapy in Clinically Vulnerable Individuals with Mild COVID-19 - COVIC-19

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 100 人开始时间: 待定最近更新: 2024年8月26日

适应症

试验速览

Trial ended prematurely

•- SARS-CoV-2 RNA detected in a specimen, <= 7 days after onset of symptoms
•- Symptoms of COVID-19
•- Clinical status not requiring admission to hospital for COVID-19 disease and
•oxygen support
•- Ability to transfuse (per randomisation) within 7 days after onset of symptoms
•- Signed written informed consent
•Additional to cohort 1:
•Men or women, 70 years or older OR under 70 years with significant
•comorbidities resulting in a COVID-age of 70 years or more according to the
•ALAMA risk calculator.
•Additional to cohort 2:
•Men or women, >=18 years of age with extremely high risk. Including patients
•with acquired immune deficiencies OR primary lymphoid immune deficiencies OR
•without detectable seroconversion >= 3 weeks after complete vaccination schedule
•with an approved vaccine.

•- Age < 16 years
•- Prior or concurrent treatment for COVID-19 (unless listed as authorized
•specific treatment in protocol)
•- History of documented SARS-CoV-2 infection in the last 90 days prior to
•- Contraindication to receiving convalescent plasma including previous history
•of transfusion-related acute lung injury (TRALI) or moderate or severe allergic
•reaction to blood components
•- Known participant objection to receiving plasma products
•- Refusal to participate expressed by patient or legally authorised
•representative
•- Pregnancy
•Additional to cohort 1:
•- Prior anti-SARS-CoV-2 immunization
•- Primary or acquired immune deficiency listed below (see cohort 2)

发起方