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

JCI Insight. 2021 Mar 22;6(6):e143196. doi: 10.1172/jci.insight.143196.


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.

Keywords: COVID-19; Immunotherapy.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Aged
  • Antibodies, Neutralizing / blood
  • Antibodies, Neutralizing / therapeutic use*
  • Antibodies, Viral / blood
  • Antibodies, Viral / therapeutic use*
  • COVID-19 / immunology
  • COVID-19 / mortality
  • COVID-19 / therapy*
  • COVID-19 / virology
  • COVID-19 Serotherapy
  • Convalescence
  • Female
  • Humans
  • Immunization, Passive
  • Immunocompromised Host
  • Immunoglobulin G / blood
  • Immunoglobulin G / therapeutic use*
  • Male
  • Middle Aged
  • Plasma*
  • Pneumonia
  • Respiration, Artificial
  • SARS-CoV-2 / immunology*
  • Severity of Illness Index*


  • Antibodies, Neutralizing
  • Antibodies, Viral
  • Immunoglobulin G

Grants and funding

Funding: This work was supported the COVID Emergency Research Fund #61315, Hackensack University Medical Center; by funds provided to the CDI by Activision Publishing Inc, Suez North America, and by NJ Stands Up to COVID. The funders of this study had no role in the study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.