The U.S. Food and Drug Administration recently issued an emergency use authorization for the use of convalescent plasma to treat COVID-19 patients. COVID-19 convalescent plasma therapy is a promising therapy doctors are using to treat certain hospitalized COVID-19 patients. Here’s a look at what COVID-19 convalescent plasma is and how it’s used to treat patients currently battling the virus.
Recently, results from the FDA-sponsored Mayo Clinic expanded access program confirmed that, like other plasma transfusions, COVID-19 convalescent plasma is safe and doesn’t appear to have significant side effects. Results from this program also suggest that patients who receive convalescent plasma from donors with high levels of virus-neutralizing antibodies have better outcomes than recipients of CCP from donors with low levels of antibodies. The amount of antibodies can vary dramatically from donor to donor.
It is important to note that the Mayo Clinic program did not have a placebo-control group, so randomized controlled trials are still needed to determine whether high-neutralizing antibody CCP truly benefits patients. This is especially important in the context of other available treatments, like remdesivir or dexamethasone, which have been shown in clinical trials to be effective. Several randomized controlled trials of CCP are underway at this time.
Under the emergency use authorization, we don’t expect access to COVID-19 convalescent plasma to change dramatically in most places where the FDA/Mayo program was already available. Convalescent plasma will still be available through the same blood providers and will remain dependent on the supply of plasma donations.
As is currently the case with all other types of blood products, patients being treated with convalescent plasma under the emergency use authorization will still need to consent to this treatment.
Under emergency use authorization status, entering safety monitoring data for each patient into the Mayo program will no longer be required; at many centers nationally safety monitoring will not be performed. Intermountain Healthcare will continue to closely monitor convalescent plasma transfusions.
The emergency use authorization status does not guarantee that patients will receive plasma with high levels of neutralizing antibody.
Randomized, controlled trials remain critical for determining whether COVID-19 convalescent plasma is effective and in which patients it’s most likely to help. Patients who choose to participate in these trials may actually have greater probability of receiving plasma with high levels of antibody than those who receive it through the emergency use authorization pathway.
If you have fully recovered from a confirmed COVID-19 diagnosis, you may be able to donate plasma to help other currently ill COVID-19 patients. To find out if you qualify or locate a donation center, contact one of these community plasma donation resources:
- The Red Cross – COVID-19 Convalescent Plasma Donation
- Intermountain Healthcare Joins National Protocol to Give COVID-19 Patients Access to Plasma Donations; Performs Utah’s First COVID-19 Transfusion
- First COVID-19 Patient in Utah to Receive Convalescent Plasma Transfusion as Part of New National Protocol for Virus Leaves Intermountain Medical Center