- This week, a network of roughly five dozen hospitals and clinics spread across five continents began enrolling patients hospitalized with COVID-19 into a randomized and placebo-controlled study aimed at better answering whether a concentrated solution of blood antibodies can help treat the coronavirus disease.
- Originally set up to test drugs for HIV, the U.S. government-funded trial network is now studying a hyperimmune globulin medicine, made from donated blood plasma of recovered COVID-19 patients that's taken and concentrated into a standardized infusion.
- Takeda and CSL Behring banded together to produce the hyperimmune globulin being studied in the trial, recruiting nearly a dozen other companies into an alliance that can draw on a broader pool of donation centers for the treatment's plasma base.
Hyperimmune globulin is different than convalescent plasma, the antibody-rich liquid taken from the donated blood of recovered COVID-19 patients.
Since it's taken from individuals, convalescent plasma can be highly variable, containing more or less of the coronavirus-targeting antibodies that give the infusion its therapeutic punch.
By extracting those antibodies from a wider pool of donated plasma, Takeda and CSL Behring can create a concentrated and, just as importantly, standardized medicine that in theory would more reliably benefit patients.
Each company has extensive experience with these types of medicines and, in April, decided to merge their separate coronavirus research programs, creating the basis of the CoVIg-19 Plasma Alliance.
The trial that got underway Thursday will test the companies' resulting hyperimmune globulin against placebo in 500 hospitalized adults who are risk of serious complications. All participants will get Gilead's COVID-19 drug Veklury as standard of care, reflecting that drug's role after being proven to shorten the time to recovery in hospitalized patients.
After seven days following treatment, researchers will compare participants' clinical status on a 7-point scale that's been used to assess other COVID-19 drugs as well.
The University of Minnesota, as a coordinating center for the HIV trial network, is sponsoring the study, with funding and support from the National Institutes of Health.
The trial, and any results that come from it, could get particular attention due to the Food and Drug Administration's recent — and controversial — emergency clearance for convalescent plasma. The data supporting that conditional authorization were not definitive, coming from an expanded access program run by the Mayo Clinic rather than a randomized, placebo-controlled study that researchers view as more trustworthy.
Concerns were also raised by public health experts about political pressure put on the FDA by the Trump administration to clear convalescent plasma before data supported its widespread use.
A panel of advisers for the National Institutes recently concluded the data for use of convalescent plasma in treating COVID-19 was insufficient, calling for more rigorous studies to be conducted.
Even if those studies are done, progress from other treatments could mean doctors turn to convalescent plasma less frequently than currently.
The hyperimmune globulin developed by Takeda and CSL could be one potential treatment in the future, should data from this trial prove positive. And initial data from synthetic antibodies developed by Regeneron and Eli Lilly appears promising. Those treatments are expected to soon win an emergency authorization from the FDA as well.