The U.S. Department of Defense (DOD) Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) awarded Johns Hopkins researchers $35 million for clinical trials to test a convalescent blood plasma outpatient treatment to fight COVID-19.
The treatment is a transfusion of a blood product from COVID-19 survivors that contains antibodies that may help the patient’s immune system fight the virus.
The randomized, double-blind trials will include 1,100 people and be conducted at over 20 ambulatory clinics in medical centers across the U.S. It will help researchers determine whether convalescent blood plasma therapy can effectively be used to treat people in the early stage of COVID-19 illness or prevent the infection in those at high risk of exposure to the virus.
“This is a story of great synergy between researchers and institutions to carry out important studies that will inform our nation and the world on how effective plasma can be to prevent COVID-19 and to treat early disease,” Arturo Casadevall, a Bloomberg Distinguished Professor who holds joint appointments in the Johns Hopkins Bloomberg School of Public Health and the Johns Hopkins University School of Medicine, said.
Currently, there are no FDA-approved vaccines to prevent infection with the SARS-CoV-2 virus, which causes COVID-19 disease. There are also no outpatient therapies to prevent hospitalization or death.
“Blood plasma therapy may have the most potential in providing immediate immunity to people at high risk of COVID-19 exposure and treating COVID-19 early to prevent hospitalization or death,” cine, David Sullivan, professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, said. “For definitive proof of this, we need a rigorous randomized clinical study to evaluate it.”
The prevention trial will include 500 people who have been exposed to COVID-19 in their homes or at work as health care providers. The companion trial will have another 600 participants who have early COVID-19 disease, meaning they are within eight days of their first symptoms but are not sick enough to be in a hospital. From the trials, the researchers hope to learn if blood plasma can prevent infection or squash it where it begins.
“There are also biological implications,” Shmuel Shoham, associate professor of medicine at the Johns Hopkins University School of Medicine, said. “We’re reviving an old approach to fight pathogens, and it may be useful for other viruses or parasites such as malaria.”