Evaluation and Characterization of SARS-CoV-2 Antibody in Convalescent Volunteer Plasma Donors for Potential Therapeutic Use

Therapeutic Candidate or Device

The therapeutic candidate is COVID-19 convalescent plasma (CCP)

Indication

The target indication is treatment of severe COVID-19 infection

Therapeutic Mechanism

Neutralizing antibodies are part of the humoral response of the adaptive immune system against viruses, and can be detected in plasma of convalescent individuals. Transfusion of COVID-19 convalescent plasma can provide neutralizing antibodies that inhibit SARS-CoV-2 infection in COVID-19 patients.

Unmet Medical Need

There currently is no approved treatment of COVID-19 infection, and CCP is available now to use in severely ill patients.

Project Objective

Prospective observational study completed

Major Proposed Activities

  • Development of a screening program in California to identify potential CCP donors
  • Characterization of the titer and neutralizing properties of anti-SARS-CoV-2 antibodies in CCP
  • Prospective analysis in CCP recipients based on the clinical course of the disease and the CCP immunogenic profile

This proposal provides support for an ongoing state-wide effort to use COVID-19 convalescent plasma (CCP) to treat severely ill patients. It will identify CCP that contains high levels of potent anti-SARS-CoV-2 antibodies, and compare against clinical outcome in patients. In addition to providing a needed service at this critical time, the information on the safety and effectiveness of CCP may be of significant value for patient management in epidemic seasons that could occur in the future.