The U.S. Food and Drug Administration (FDA) issued guidance on Wednesday for health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 during the public health emergency.
Convalescent plasma that contains antibodies to the novel coronavirus is possibly effective against the infection, according to the FDA.
Since COVID-19 convalescent plasma has not yet been approved for use by the FDA, it is regulated as an investigational product, said the agency in a release.
A health care provider must participate in one of the three pathways for use of investigational convalescent plasma, which are clinical trials, expanded access and single patient emergency IND, according to the FDA.
The FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma. Health care providers or acute care facilities would instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment, said the agency.
Health care providers are required to maintain records for the COVID-19 convalescent plasma unit(s) administered to the COVID-19 patient, said the FDA.
