Although promising as an investigational treatment being explored for combating COVID-19, the use of convalescent plasma collected from individuals who have recovered from COVID-19 has not yet been shown to be safe and effective as a treatment for the virus, the U.S. Food and Drug Administration (FDA) says.
“It is important to study the safety and efficacy of COVID-19 convalescent plasma in clinical trials,” FDA says in a new guidance. It provides recommendations to healthcare providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.
Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product. Therefore, use of COVID-19 convalescent plasma by a healthcare provider must be under an Investigational New Drug application (IND) under the traditional IND regulatory pathway, an expanded access IND, or a single-patient emergency IND application.
Convalescent plasma that contains antibodies to severe acute respiratory syndrome coronavirus 2 or SARS-CoV-2 (the virus that causes COVID-19) is being studied for administration to patients with COVID-19. Use of convalescent plasma has been studied in outbreaks of other respiratory infections (e.g., the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic), FDA notes.
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 in the Code of Federal Regulations). The Center for Biologics Evaluation and Research’s Office of Blood Research and Review “is committed to engaging with sponsors and reviewing such requests expeditiously,” FDA says in the guidance.
Edited by Michael Causey
