FDA approves the first U.S. coronavirus treatment with recovered plasma

Can the blood of coronavirus survivors treat the newly sick

The technique has been around for centuries and was used during the 1918 flu pandemic.

Treatment may be the best hope for COVID-19 patients with serious illnesses, while scientists are working on developing new and specific treatments for the disease and testing experimental drugs such as chloroquine and remdesivir.

The FDA's decision comes a day after New York Gov. Andrew Cuomo announced that the state's health department planned to begin treating the sickest coronavirus patients with antibody-rich plasma extracted from the blood of those who've recovered. Returning travellers are asked to self-isolate for 14 days in case they develop symptoms and to prevent spreading the virus to others. And initial reports from China suggest convalescent plasma might also be effective in dulling the effects of COVID-19.

The FDA is not approving using plasma as a treatment, instead using it as a clinical trial and for the treatment of those who are critically ill.

Most requests will receive a response from the FDA within four to eight hours, according to the agency's statement. For patients who require treatment faster, doctors can call the FDA's Office of Emergency Operations to get approval over the phone.

The procedure, called "convalescent plasma transfusion", extracts blood plasma from survivors of the coronavirus disease and infuses it to now COVID-19 positive patients. The Researchers will then evaluate whether convalescent plasma improves disease outcomes. Therefore, given the public health emergency that the expanding COVID-19 outbreak presents, while clinical trials are being conducted, FDA is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 CFR 312.310.

Health officials are also working on a serological drug that tests whether a person already has the antibodies that prove they've recovered from coronavirus.

On March 23, the NY governor, Andrew Cuomo, said that "We think it shows promise" using convalescent plasma to help with the state's hospitalization response to the outbreak.



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