FDA Champions Recovered COVID-19 Patients to Consider Donating Plasma for Development of Blood-based Therapies

Apr 17, 2020 | Convalescent Plasma, COVID-19, FDA, Food and Drug Administration, Popular Posts

FDA Champions Recovered COVID-19 Patients Consider Donating Plasma for Development of Blood-based Therapies

The U.S. Food and Drug Administration (FDA), embracing the All-of-America approach to fighting the COVID-19 pandemic, updates the country on a treatment called convalescent plasma, encouraging those who have recovered from COVID-19 to donate plasma to help others fight the disease. Convalescent plasma can be used to manufacture a biological product used to treat patients with COVID-19.

What is Convalescent plasma?

This is an antibody-rich product made from blood donated by people who have recovered from the disease caused by novel coronavirus.

Why is this product important?

Prior experience with respiratory viruses and limited data that have emerged from China suggest that convalescent plasma has the potential to lessen the severity of shorten the length of illness caused by COVID-19.

Is the FDA imposing a controlled approach—involving clinical trials and/or careful emergency use?

Yes. The regulatory agency notes the importance that this potential therapy is evaluated in the context of clinical trials, through expanded access, as well as facilitate emergency access for individual patients as appropriate.

What has the response been like to the FDA’s recently announced national efforts to facilitate the development and access to convalescent plasma via the Mayo Clinic-led expanded access protocol?

Absolutely tremendous. First, TrialSite News reports literally hundreds of individuals contacted us, asking if we could connect them to the National COVID-19 Convalescent Project. Second, the FDA has received positive response and a signed petition from over 1,040 research sites and 950 physician investigators.

As a number of clinical trials are occurring assessing the safety and efficacy of convalescent plasma, has the FDA granted numerous single patient emergency investigational new drug (eIND) applications as well?

Yes.

What is the new FDA webpage to help guide COVID-19 patients to local blood or plasma collection center to discuss their eligibility and potentially schedule an appointment to donate?

See the website Donate COVID-19 Plasma. The website also provides information for those interested in participating in the expanded access protocol, conducting clinical trial or submitting IND applications.

What is the American Red Cross Website?

The American Red Cross has set up a website for interested donors.

How can people give back during this challenge?

If you have recovered, you can potentially donate your blood. This can have the potential to help up to four patients. 

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