Emergent BioSolutions Inc. is conducting phase clinical 3 trials of its plasma-derived therapy for outpatient treatment of COVID-19, the company announced this week.
The randomized clinical trial will assign participants to receive infusions of either a placebo or the plasma treatment. Emergent is one of two companies providing hyperimmune globulin products for the trial, which plans to enroll 820 patients across the U.S. and abroad.
Researchers will evaluate the effectiveness of hyperimmune globulin products taken from plasma donations of people who have recovered from the coronavirus and developed the disease-fighting antibodies.
The treatment targets COVID-19 patients who are at risk of becoming severely ill, including immunocompromised adults and anyone 55 or over.
“This earlier intervention has the potential to improve patient outcomes and keep people out of the hospital,” said Laura Saward, senior vice president and therapeutics business unit head at Emergent BioSolutions, according to a statement.
The news comes a month after federal regulators allowed the company’s East Baltimore plant to resume production of the Johnson & Johnson vaccine. In April, the U.S. Food and Drug Administration ordered the plant to pause production after ingredient mix-ups ruined 75 million doses.
Like monoclonal antibody therapy, Emergent’s plasma-derived treatment is meant as an outpatient treatment for people who are at risk of developing severe illness from COVID-19 but who haven’t yet needed to be hospitalized.
Monoclonal antibodies are the therapy used to treat then-President Donald Trump’s infection last October. Maryland has been working to promote and expand access to the lab-made immune system builder, currently the only therapy for those who are not hospitalized, The Baltimore Sun reported in March.
Researchers say monoclonal antibodies don’t necessarily work against variants, such as the delta strain now dominating in Maryland and elsewhere. Antibodies in blood plasma don’t need to be adapted for variants, since they’re taken from people who are infected with whatever strain is circulating.
Researchers at Johns Hopkins University, in Chinese labs and elsewhere have been exploring plasma-based treatments for COVID-19. Emergent is also looking into a potential treatment made from the plasma of immunized horses.
The new treatment will use an Emergent platform established in partnership with The Biomedical Advanced Research and Development Authority, a federal health agency, for anthrax and smallpox vaccine complications. BARDA awarded Emergent a $14.5 million grant for the plasma research, The Sun reported last year.
The National Institute of Allergy and Infectious Disease, part of the National Institutes of Health, is sponsoring the clinical study, called “Outpatient Treatment with Anti-Coronavirus Immunoglobulin.” The study is set to complete by August 2023.