Convalescent Plasma Treatment Is Green-Lit
The U.S. Food and Drug Administration (FDA) issued new guidance to provide recommendations to healthcare providers on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 disease.
Announced on August 19, 2020, the FDA stated, ‘Convalescent plasma is being investigated for the treatment of COVID-19 because there is no approved treatment for this new disease. There is some information that suggests convalescent plasma might help some patients recover from COVID-19, says the U.S. CDC.’
‘Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product.’
Convalescent plasma is the liquid part of blood collected from patients who have recovered from the COVID-19 disease. COVID-19 patients develop antibodies in the blood against the virus. Antibodies are proteins that might help fight the infection, says the CDC.
The use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic, and the 2012 MERS-CoV epidemic.
However, the FDA does not collect COVID-19 convalescent plasma or provide COVID-19 convalescent plasma.
Healthcare providers or acute care facilities should instead obtain COVID-19 convalescent plasma from an FDA-registered blood establishment.
To increase awareness of the need for donations, the FDA launched a PSA in August 2020.
‘If you have fully recovered from COVID-19, you may be able to help patients currently fighting the infection by donating your plasma. Because you fought the infection, your plasma now contains COVID-19 antibodies,’ said FDA Commissioner Stephen Hahn, M.D., in a video message.
‘These antibodies provided one way for your immune system to fight the virus when you were sick, so your plasma may be able to help others fight off the disease.’
‘People who have fully recovered from COVID-19 for at least 2-weeks are encouraged to consider donating plasma, which may help save the lives of other patients. COVID-19 convalescent plasma must only be collected from recovered individuals if they are eligible to donate blood.’
‘Individuals must have had a prior diagnosis of COVID-19 documented by a laboratory test and meet other donor criteria. Individuals must have complete resolution of symptoms for at least 14-days before donation.’
‘A negative lab test for active COVID-19 disease is not necessary to qualify for donation,’ concluded Dr. Hahn.
Further investigation is still necessary to determine if a convalescent plasma is safe and effective as a treatment for COVID-19, and whether it might shorten the duration of illness, reduce morbidity, or prevent death associated with COVID-19.
The U.S. Government is supporting a national effort to collect and provide convalescent plasma to patients in need across the country.
The protocol requires the patient or their healthcare proxy to consent to receive convalescent plasma from someone who has recovered from COVID-19.
Only hospitalized COVID-19 patients who meet specific criteria and who are referred by their healthcare provider will participate in this protocol.
Additional COVID-19 treatments are listed at CoronavirusToday.
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