Plasma Trials From Recovered COVID-19 Patients Has Begun
On April 3, the U.S. Food and Drug Administration (FDA) announced that it has approved plans for nationwide trials of two potential treatments for COVID-19.
In this post, we’re going to quickly discuss these plasma trials and what it means for the treatment of COVID-19 moving forward. Let’s dive right in.
What Are The Plasma Trials?
The FDA is taking the lead on facilitating the development of two potential therapies for COVID-19 that will be derived from human blood.
The two plasma studies are:
- Convalescent plasma
- Hyperimmune globulin
Both are antibody-rich blood products that are created from blood that is donated by people who have had and recovered from, the virus. These products/therapies can then be given as treatments to those who are diagnosed with COVID-19.
As we stand today, there is some limited data that suggests that each may be beneficial in the treatment of COVID-19, but further evaluation is needed. That’s why the FDA is spearheading clinical trials for each.
The goal, according to a press release from the FDA announcing the trials, is to develop and “bring blood-related therapies for COVID-19 to market as fast as possible.” In the same release, HHS Secretary Alex Azar says patients will be able to benefit from the new therapies “in the coming weeks,” showing the urgency of the trials and rush to get the therapies to the public.
FDA Commissioner Stephen M. Hahn, M.D. also stressed the speed and collaboration involved in the trials.
“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. 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.”
Where Is The Plasma Coming From?
The FDA has guidelines in place to help health care providers to treat individual patients with plasma. Meanwhile, the FDA is working with academic institutions to test the safety of the convalescent plasma.
As for where this plasma comes from — a collaborative effort is in place to develop and implement a protocol that will deliver convalescent plasma to patients in need in areas of the country that may not have access to any of the institutions that are conducting the clinical trials.
The Mayo Clinic and the American Red Cross are leading the effort to collect and distribute the plasma. Pilot programs to collect plasma in several states have already begun. The FDA anticipates that thousands of units of plasma will be available for patients in need in the coming weeks.
Who Can Donate Plasma?
The FDA is accelerating the development of hyperimmune globulin by collecting convalescent plasma. Donors are those individuals who have fully recovered from COVID-19. This means they have been symptom-free for at least two weeks.
Any individuals who fit these criteria are encouraged to donate as their plasma could potentially help to save lives. In fact, each plasma donation could help save up to four lives. Anyone willing to donate plasma can get more information from the American Red Cross.