Component 3: Clinical Trials

Introduction

The FDA welcomes IND submissions to authorize further trials, as per the wording in the FDA website: “Investigators wishing to study the use of convalescent plasma in a clinical trial should submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR Part 312). CBER’s Office of Blood Research and Review is committed to engaging with sponsors and reviewing such requests expeditiously.”

On this site, we will post protocols clinical trials only related to convalescent plasma. For a comprehensive list of all clinical trials related to COVID-19 (including those outside of convalescent plasma), you can visit the COVID-19 Collaboration Platform.

Several new IND submissions have been given to the FDA. We hope to learn of all submissions and list them here.