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

AbstractObjectivesGeneral: To assess the safety, efficacy and dose response of convalescent plasma (CP) transfusion in severe COVID-19 patientsSpecific:a. To identify the appropriate effective dose of CP therapy in severe patientsb. 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 mortalityc. To assess the clinical improvement after CP transfusion in severe COVID-19 patientsd. To assess the laboratory improvement after CP transfusion in severe COVID-19 patientsTrial DesignThis is a multicentre, multi-arm phase II Randomised Controlled Trial.ParticipantsAge 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 are1. Respiratory rate> 30 breaths/min; PLUS2. Severe respiratory distress; or SpO2 ≤ 88% on room air or PaO2/FiO2≤ 300 mm of Hg, PLUS3. Radiological (X-ray or CT scan) evidence of bilateral lung infiltrate, AND OR4. Systolic BP< 90 mm of Hg or diastolic BP<60 mm of Hg.AND/OR5. Criteria 1 to 4 AND or patient in ventilator supportPatients ’ below18 years, pregnant and lactating women, previous history of allergic reaction to plasma, patients who have already received plasma from a different source will be excluded. Patients will be enrolled at Bangabandhu Sheikh Mujib Medical Universit...
Source: Trials - Category: Research Source Type: clinical trials