Convalescent plasma compared to standard plasma for treatment of hospitalized non-ICU patients with COVID-19 infections

eiden University Medical Center0 个研究点目标入组 430 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

暂无简介。

•1.Maximal 3 days hospitalized at plasma infusion.
•2.Age = 18 years and = 85 years
•3.SARS-CoV-2 infection: confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) not longer than 7 days before.
•4.Symptoms not expected to lead to IC transfer within 6 hours of study plasma administration
•5.Written informed consent including storing of specimen for future testing

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•1.Accompanying diseases other than COVID-19 with an expected survival time of less than 6 months
•2.Chronic severe pulmonary dysfunction like obstructive lung disease (COPD), Gold stage 4; severe emphysema; or lung fibrosis with usual interstitial pneumonia (IUP) pattern
•3.Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to = 30% for which among others e.g. strict fluid restriction is needed
•4.Clinical diagnosis of circulatory overload for which active therapy (like increased doses of diuretics) is initiated
•5.Clinical judgement of deterioration in oxygenation (e.g. more than 2 L increase in additonal O2 by nose tube), respiratory rates ( e.g. more than 5 / min increase) in the 2 hours before the planned randomisation / plasma infusion
•6.Signs of severe coagulopathy : thrombocytopenia by consumption ( <100 x 10e9/l) or prolongation of the PT (+3 sec) , PTT (+ 5 sec)
•7.Any history of severe adverse reactions to plasma proteins
•8.Known deficiency of immunoglobulin A
•9.Pregnancy
•10.Breastfeeding women
•11.Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance

发起方

eiden University Medical Center