19 May 2020 | News
Convalescent plasma donation helps in evaluating potential COVID-19 therapy in the context of clinical trials and might also assist in the development of Blood-Related Therapies
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As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration has been working with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to treat this novel virus.
On 16 May 2020, FDA provided an update on a potential treatment called convalescent plasma and encouraging those who have recovered from COVID-19 to donate plasma to help others fight this disease.
Convalescent plasma is an antibody-rich product made from blood donated by people who have recovered from the disease caused by the virus. Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity or shorten the length of illness caused by COVID-19. It is important to evaluate this potential therapy in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients, as appropriate.
The response to the agency’s recently announced national efforts to facilitate the development of and access to convalescent plasma has been tremendous. More than 1,040 sites and 950 physician-investigators nationwide have signed on to participate in the Mayo Clinic-ledExternal Link Disclaimer expanded access protocol. A number of clinical trials are also taking place to evaluate the safety and efficacy of convalescent plasma and the FDA has granted numerous single patient emergency investigational new drug (eIND) applications as well.
As this work moves forward, the key to ensuring the availability of convalescent plasma to those in greatest need is getting recovered COVID-19 patients to donate plasma. The FDA has launched a new webpage to guide recovered COVID-19 patients to local blood or plasma collection centers to discuss their eligibility and potentially schedule an appointment to donate. The webpage also provides information for those interested in participating in the expanded access protocol, conducting clinical trials or submitting eIND applications. The American Red Cross has also set up a website for interested donors (www.redcross.org/plasma4covidExternal Link Disclaimer) and the FDA continues to work with others in this area to help encourage additional donations.
FDA notes that one donation has the potential to help up to four COVID-19 patients. Convalescent plasma can also be used to manufacture a biological product called hyperimmune globulin, which can similarly be used to treat patients with COVID-19.
FDA encourages people who have fully recovered from COVID-19 for at least two weeks to contact their local blood or plasma collection center today to schedule an appointment.