Integrated COVID-19 Convalescent Plasma Treatment and Antibody Research Program at a Single Academic Medical Center

Background: Convalescent plasma is a potential therapy for COVID-19. Using existing resources at a single academic medical center, we established an integrated convalescent plasma treatment and antibody research program to treat patients with severe COVID-19 and to advance vaccine design.Methods: We redeployed existing hospital infrastructure and personnel to conduct an open label clinical trial to treat hospitalized COVID-19 patients. Confirmed COVID-19 convalescent plasma donors were recruited 28 days following symptom resolution. Whole blood donation occurred at our institution’s blood establishment and plasma was processed in standard fashion. Clinical, cellular and serological characterization of donors and recipients was performed.Findings: 16 days after study initiation, 548 interested convalescent plasma donors were recruited and 10 recipients were transfused. Interested donors were mostly female (61.9%) and commonly first-time blood donors (36.3%). Convalescent plasma transfused into 10 recipients contained variable levels of anti-receptor binding domain (range 1:73 to 1:3892) and anti-spike (range 1:69 to 1:2921) antibody titer. Two recipients were on venovenous extracorporeal membrane oxygenation, one was mechanically ventilated, one was on high-flow nasal cannula and the remainder were on nasal cannula or room air. Five had received anti-viral or anti-inflammatory treatments and two were immunosuppressed after lung and stem cell transplantation. Respiratory support, SOFA scores and C-reactive protein levels variably improved. Nasopharyngeal SARS-CoV-2 remained positive in 8 patients at day 7 post-transfusion. No mortality or toxicity was observed; four recipients were discharged (one was readmitted).Interpretation: Developing a convalescent plasma therapy and translational research program for COVID-19 is feasible and safe within existing hospital infrastructure. The availability of a pre-existing hospital-based blood establishment significantly eased convalescent plasma procurement. Variability among convalescent antibody titers and treatment response exists. No adverse events, including antibody-dependent disease enhancement, were observed. Further studies are needed to determine optimal convalescent plasma donors, timing of therapy and clinical efficacy.Trial Registration: This clinical trial was registered at ClinicalTrials.gov with identifier NCT04340050. Funding Statement: Department of Surgery, University of Chicago; National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Centers (CIVIC) contract 75N93019C00051.Declaration of Interests: All authors declare no competing interests.Ethics Approval Statement: This study was approved by the Institutional Review Board (IRB20-0523). All participants (plasma donors and plasma recipients) gave informed consent.