Publications

The researchers and institutions participating in the Expanded Access Program (EAP) for the treatment of COVID-19 are committed to facilitating the growth of medical knowledge in a timely manner. Collectively, they publish articles in peer-reviewed biomedical journals to document the safety and efficacy of convalescent plasma for the treatment of severe or life-threatening COVID-19.

Publishing in medical journals is an expected scholarly activity of professional practice and aligns with the value of sharing expertise and best practices to facilitate the advancement of medical practice.

The links below are publications authored by the EAP team to document their research findings related to convalescent plasma to expedite finding treatments and possibly a cure for COVID-19 during a worldwide pandemic.

Evidence to Support Emergency Use of Convalescent Plasma

The FDA has posted a document summarizing updated evidence to support the emergency use of COVID-19 Convalescent Plasma. The agency continues to review the circumstances and appropriateness of the authorization for emergency use. To make this information accessible to the public, the document presents FDA’s review in relatively plain language.

EAP to EUA Transition

This document compares an Expanded Access Program to Emergency Use Authorization and explains the differences between the two.

Data Collection & Publication

The sponsor of this Expanded Access Program (EAP) will limit the publication of any partial data collected by any participating treating physician or site without prior written authorization.

With rare exceptions, such authorization will likely come after the sponsor has closed program enrollment, completed the data analysis, and evaluated the final data set for the primary safety outcomes.

The rationale for this approach is that the data being collected under the Convalescent Plasma EAP will be used to assess safety and help guide regulatory decision making. Thus, per FDA guidance, the data should not be subdivided until the sponsor has completed key safety (and to the extent possible) efficacy analyses.

Data Safety Monitoring Board Report Summary