#12: The Safety and antibody kinetics of COVID-19 Convalescent Plasma for the Treatment of Moderate to Severe Cases of SARS-CoV-2 Infection in Pediatric Patients

Abstract Introduction A novel Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was identified as the pathogen responsible for a serious, life threatening respiratory infection (COVID-19) initially reported in Wuhan, China which rapidly spread worldwide resulting in global pandemic. Multiple immunological and pharmacological therapies have been evaluated with variable results. Convalescent plasma has been used in previous outbreaks such as Influenza 1918 and 2009, Ebola, MERS and SARS with good efficacy and safety reported. There have been multiple large reports on the safety of COVID-19 convalescent plasma (CCP) for the treatment of this serious infection in the adults; controversy has ensued regarding its efficacy. Pediatric data on CCP use are limited. Methods We conducted a prospective, open label treatment trial using CCP (10 ml/kg up to 1 unit) for the treatment of COVID-19 in pediatric patients with moderate to severe disease or high risk for serious illness. Safety and antibody kinetics and outcome data were collected. Results Eighteen moderate to severe COVID19 pediatric patients were enrolled and received CCP early in their illness (median days of symptoms XX). We observed no infusion related adverse events, no hematological or metabolic adverse events were noted during the hospitalization and at 3 weeks after infusion follow up. Sixteen patients demonstrated significant clinical improvement by day seven post infusion, as measured by the WHO eight-category ordinal severity scale for COVID-19. Presence of SARS-COV-2 anti-nucleocapsid IgG was demonstrated in all CCP specimens, a significant increase in antibodies was demonstrated in CCP recipients 24 hours after receiving CCP. Sustained high levels of anti- SARS-COV-2 anti-nucleocapsid IgG was demonstrated at 7- and 21-days post-transfusion. A transient IgM response not associated with CCP was noted. Eleven (61.1%) patients were discharge to home by day 7 post CCP infusion. One patient remained on invasive ventilatory support 21 days after CCP infusion and was eventually discharged to an intermediate care facility, one patient died retrospectively confirmed to have been brain death before receiving CCP. Conclusion We conclude that CCP was well tolerated in pediatric patients. CCP resulted in rapid increase of antibodies and sustained levels 21 days after infusion suggesting that CCP did not interfere with patients own immune response. More data are necessary to establish efficacy of this intervention in children, but our patients clinical course suggests benefit of CCP. Pediatric patients with moderate to severe COVID-19 may benefit of CCP when used early in the course of illness in conjunction with other immunological or antiviral interventions as needed.