A National Collaborative Multicenter Phase II Study for Potential Safety Efficacy of Convalescent Plasma to Treat Severe COVID-19 Patients

▪ Introduction Coronavirus disease (COVID-19) pandemic has started to affect Saudi Arabia in the beginning of March 2020 and is expected to cause significant morbidity to many patients, especially to elderly, who might require intensive care unit (ICU) support to survive as its lethality increases with the increasing age. Recent publications suggested the benefit of utilizing convalescent plasma from recovered donors as a therapeutic approach in treating COVID-19 patients. Convalescent plasma could provide our first-line defense for people with COVID-19, especially those who are older and at a much higher risk for complications., therefore, we developed a national protocol to investigate the safety, benefit and applicability at larger scale and at different health care facilities in Saudi Arabia (KSA). Objectives Primary endpoints are 1. ICU (or designated area for critical patients) length of stay 2. Safety of convalescent plasma> Secondary endpoints included: 1. 30 days mortality 2. Number of days on mechanical ventilation 3. Days to clinical recovery Method Eligible convalescent plasma donors will be invited to participate in trial. The arrangement for plasmapheresis will start after obtaining donor informed consent. The collected plasma will be treated with pathogen reduction system. The convalescent plasma units will be labelled, stored and shipped as per the standard transfusion medicine protocols. It will be used only for eligible patients' “recipients” as per the following eligibility criteria: 1. Inclusion criteria: - Confirmed case of SARS-CoV-2 infection with POSITIVE rRT PCR test -18 or older -Must have been requiring ICU care or severe or immediately life-threatening care (any one of the following): 1. Patient requiring ICU care/admission. 2. Severe disease is defined as: a. Dyspnea b. Respiratory frequency ≥ 30/min c. Blood oxygen saturation ≤ 93% d. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300, and/or Lung infiltrates > 50% within 24 to 48 hours 3. Life-threatening disease is defined as: a. Respiratory failure b. Septic shock, and/or c.Multiple organ dysfunction or failure Exclusion criteria: 1. Negative or non-conclusive test COVID-19 rRT PCR test 2. Mild symptoms 3. Hospitalization not requiring ICU care/admission Eligible Patients will be infused with the convalescent plasma (200-400 ml / treatment dose)at least once & if possible, daily, for up to 5 sessions. Other supportive and therapeutic measures sho