Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A struc
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Convalescent plasma transfusion therapy in severe COVID-19 patients- a safety, efficacy and dose response study: A structured summary of a study protocol of a phase II randomized controlled trial Fazle Rabbi Chowdhury1*† , Ashraful Hoque2†, Forhad Uddin Hasan Chowdhury3, Md. Ruhul Amin4, Abdur Rahim5, M. Mujibur Rahman3, Rubina Yasmin6, Md. Robed Amin3, Md. Titu Miah6, Md. Abul Kalam2 and Md. Sayedur Rahman1,7
Abstract Objectives: General: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patients Specific: a. To identify the appropriate effective dose of CP therapy in severe patients b. To identify the efficacy of the therapy with their end point based on clinical improvement within seven days of treatment or until discharge whichever is later and in-hospital mortality c. To assess the clinical improvement after CP transfusion in severe COVID-19 patients d. To assess the laboratory improvement after CP transfusion in severe COVID-19 patients Trial Design: This is a multicentre, multi-arm phase II Randomised Controlled Trial. Participants: Age and sex matched COVID-19 positive (by RT-PCR) severe cases will be enrolled in this trial. Severe case is defined by the World Health Organization (W.H.O) clinical case definition. The inclusion criteria are 1. Respiratory rate > 30 breaths/min; PLUS 2. Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS 3. Radiological (X-ray or CT scan) evidence of bilateral lung infiltrate, AND OR 4. Systolic BP < 90 mm of Hg or diastolic BP
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