FDA Expands On 2 Coronavirus Treatment Trials

The FDA announced expansions of clinical trials and potential for expanded access programs for two treatments for COVID-19. The FDA announced this latest national effort to bring blood-related therapies for the novel coronavirus (COVID-19) global pandemic this afternoon. The two potential treatment products are called convalescent plasma and hyperimmune globulin.

The U.S. Food and Drug Administration is "taking the lead on a national effort to facilitate the development of, and access to," two new potential treatments for COVID-19. These treatments are, at the moment, investigational therapies. Both of these therapies are derived from human blood.

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These products are made from blood donated by people who've had COVID-19 and recovered from the virus. The FDA suggested that there are some "limited data to suggest" that these two products, convalescent plasma and hyperimmune globulin, "may have benefit in the COVID-19 illness." But there is much testing that still needs doing.

"This is an important area of research — the use of products made from a recovered patient's blood to potentially treat COVID-19 in those affected by this illness," said FDA Commissioner Stephen M. Hahn, M.D. "The FDA remains actively engaged with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to prevent and treat this novel virus – both evaluating the safety and efficacy of potential therapies and facilitating emergency access for patients, as appropriate."

Those people that have tested positive for COVID-19 and have recovered are encouraged to read about and potentially donate to the American Red Cross plasma drive. You can see a Plasma Donations from Recovered COVID-19 Patients page at the American Red Cross online right this minute.

If you wish to donate convalescent plasma, the Red Cross notes that you will not be using the regular appointment scheduling tool on their website or mobile app. There is a special form on the website linked above which must be filled out and submitted before any donation can take place. You will then be contacted by Red Cross for "special scheduling."

Per the FDA's site on Convalescent Plasma, the following considerations for donor eligibility should be addressed:

- Prior diagnosis of COVID-19 documented by a laboratory test

- Complete resolution of symptoms at least 14 days prior to donation

- Female donors negative for HLA antibodies or male donors

- Negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from blood.*

- Defined SARS-CoV-2 neutralizing antibody titers, if testing can be conducted (e.g., optimally greater than 1:320)

*The FDA notes that negative results for COVID-19 must be shown before an individual (who has had positive results for COVID-19 before) can donate plasma. Per the FDA, "a partial list of available lists can be accessed at the FDA's Emergency Situations Medical Devices EUA site. EUA stands for Emergency Use Authorizations – this is the same page we pointed to for the big 2-minute test FDA approval "misunderstanding" situation from earlier this week.