Clinical and laboratory evaluation of patients with SARS-CoV-2 pneumonia treated with high-titer convalescent plasma

Donato, Michele L.; Park, Steven; Baker, Melissa; Korngold, Robert; Morawski, Alison; Geng, Xue; Tan, Ming; Ip, Andrew; Goldberg, Stuart; Rowley, Scott; Chow, Kar; Brown, Emily; Zenreich, Joshua; McKiernan, Phyllis; Buttner, Kathryn; Ullrich, Anna; Long, Laura; Feinman, Rena; Ricourt, Andrea; Kemp, Marlo; Vendivil, Mariefel; Suh, Hyung; Balani, Bindu; Cicogna, Cristina; Sebti, Rani; Al-Khan, Abdulla; Sperber, Steven; Desai, Samit; Fanning, Stacey; Arad, Danit; Go, Ronaldo; Tam, Elizabeth; Rose, Keith; Sadikot, Sean; Siegel, David; Gutierrez, Martin; Feldman, Tatyana; Goy, Andre; Pecora, Andrew; Biran, Noa; Leslie, Lori; Gillio, Alfred; Timmapuri, Sarah; Boonstra, Michele; Singer, Sam; Kaur, Sukhdeep; Richards, Ernest; Perlin, David S.

Here, we report on a phase IIa study to determine the intubation rate, survival, viral clearance, and development of endogenous Abs in patients with COVID-19 pneumonia treated with convalescent plasma (CCP) containing high levels of neutralizing anti–SARS-CoV-2 Abs. Radiographic and laboratory evaluation confirmed all 51 treated patients had COVID-19 pneumonia. Fresh or frozen CCP from donors with high titers of neutralizing Abs was administered. The nonmechanically ventilated patients (n = 36) had an intubation rate of 13.9% and a 30-day survival rate of 88.9%, and the overall survival rate for a comparative group based on network data was 72.5% (1625/2241). Patients had negative nasopharyngeal swab rates of 43.8% and 73.0% on days 10 and 30, respectively. Patients mechanically ventilated had a day-30 mortality rate of 46.7%; the mortality rate for a comparative group based on network data was 71.0% (369/520). All evaluable patients were found to have neutralizing Abs on day 3 (n = 47), and all but 1 patient had Abs on days 30 and 60. The only adverse event was a mild rash. In this study on patients with COVID-19 disease, we show therapeutic use of CCP was safe and conferred transfer of Abs, while preserving endogenous immune response.