FDA OKs Convalescent Plasma for Treating Critically Ill COVID-19 Patients
The same day that New York Gov. Andrew Cuomo announced the initiation of a clinical trial using blood plasma from patients who have recovered from COVID-19, the U.S. Food and Drug Administration (FDA) announced wider support for the practice.
The FDA said Tuesday that it will allow physicians to use what is referred to as convalescent plasma collected from recovered COVID-19 patients in an attempt to treat patients who are critically ill from the virus that was declared a pandemic. The idea is that the plasma, which contains antibodies against the virus, will be administered into patients who are critically ill. In a guidance announced Tuesday, the FDA said it is possible that the treatment could be effective against the infection, although there is scant evidence to support that as of now. The use of convalescent plasma has been studied in outbreaks of other respiratory infections, including the 2009-2010 H1N1 influenza virus pandemic, 2003 SARS-CoV-1 epidemic, and the 2012 MERS-CoV epidemic.
“Although promising, convalescent plasma has not been shown to be effective in every disease studied. It is therefore important to determine through clinical trials, before routinely administering convalescent plasma to patients with COVID-19, that it is safe and effective to do so,” the FDA said in its guidance.
While the FDA believes that participation through controlled clinical trials is a better option for patients to obtain access to convalescent plasma, in the time of a global pandemic it’s just not feasible. Given the public health emergency of COVID-19, the FDA said it will facilitate access to this treatment option. The regulatory agency said it was allowing doctors to use this procedure through the process of single patient emergency Investigational New Drug Applications under its authority. The FDA said it will expedite emergency requests for this via telephone calls if physicians need an answer within hours. The FDA said this authorization does not include the use of COVID-19 convalescent plasma for the prevention of infection.
The FDA set strict guidelines for the blood to be used in this procedure. The blood can only be taken from a patient who is eligible to donate blood only if a prior diagnosis of COVID-19 has been documented by a laboratory test. The donor must have been symptom-free from their illness for 14 days. Patients who can receive the donated plasma must have severe or immediately life-threatening COVID-19. Severe symptoms include low blood oxygen levels, poor respiratory frequency and other complications. Life-threatening disease includes respiratory and organ failure, as well as other complications.
The state of New York is working with an unnamed pharmaceutical company on its clinical program with convalescent plasma. Takeda Pharmaceutical is known to be working on developing a treatment for COVID-19 from the blood of patients who have recovered. Takeda’s TAK-888 is an anti-SARS-CoV-2 polyclonal hyperimmune globulin currently in development to treat high-risk individuals with COVID-19.