The Food and Drug Administration (FDA) plays an important role in helping protect the United States from from public health care threats like Coronavirus Disease 2019 (COVID-19) pandemic.
In its effort to protect the public, the FDA has recently approved clinical trials to use convalescent plasma of individuals who have recovered from COVID-19 as a form of treatment. The hope is that the antibodies developed by recovered patients might help fight the virus in patients who are still struggling with the disease.
The use of convalescent plasma has been studied for other respiratory infectious outbreaks like the 2009-2010 H1N1 virus pandemic, 2003 SARS-COV-1 epidemic and 2012 MER-CoV epidemic.
Although promising, convalescent plasma hasn’t yet been proven effective to treat COVID-19. Therefore, the FDA is allowing testing through clinical trials first before administering convalescent plasma to patients with COVID-19.
Once treatment has shown to be effective in clinical trials, the FDA can approve it to be used in the general public.
Investigators wishing to study the effectiveness of convalescent plasma on COVID-19 patients are encouraged to submit a request to the FDA for the investigational use under the traditional IND regulatory pathway (21 CFR 321).
Due to the pandemic, the FDA is also working with several federal partners and academia to offer an extended access for patients with severe or life-threating COVID-19 disease who might not be able to participate in other clinical trials and who would like to receive the convalescent plasma experimental treatment.
Given the public health emergency, the FDA is also expanding its access to this experimental treatment to treat serious or life-threating COVID-19 patients with convalescent plasma through a request by their doctors to form part of the Single Patient Emergency IND.
Requesting physicians may contact the FDA by completing the 3926 form and emailing it to CBER_eIND_Covid-19@FDA.HHS.gov. For severe emergency cases, where approval is needed in less than 4 hours or in cases where physicians can’t submit forms electronically, physicians can call the FDA’s Office of Emergency Operations at 1-866-300-4373 to seek verbal authorization. For more information click here.
