April 14, 2020
People who have successfully recovered from COVID-19 potentially may help people who are still struggling with coronavirus infections by donating plasma.
Penn Medicine researchers have set up a donor registry to collect plasma to be used in a clinical trial evaluating the effectiveness of convalescent plasma therapy against COVID-19. Plasma contains the antibodies that recovered patients have built to provide immunity against the coronavirus.
Convalescent plasma therapy has been around for more than 100 years and can be an important line of defense against diseases that don't have a vaccine. It has been used during the H1N1 pandemic and to treat patients with SARS and MERS. Now, it is being considered as a possible treatment option for COVID-19.
The therapy involves plasmapheresis, a process in which a donor's plasma is separated from the blood cells so that it can be transfused into a sick patient, providing them the antibodies needed to fight a particular infection.
The U.S. Food and Drug Administration recently issued recommendations for investigational COVID-19 convalescent plasma. The guidelines identify the pathways for which the COVID-19 convalescent plasma may be used including clinical trials, expanded access programs and single patient emergency use.
A study in the March issue of the Journal of the American Medical Association found some success with this technique in five COVID-19 patients in China. According to the data, viral loads were negative in all five patients by the 12th day after the transfusion.
Penn Medicine has developed two separate protocols to study CVOID-19 convalescent plasma therapy, according to Chief Clinical Research Officer Emma Meagher.
The first is the donor registry. The second is a clinical trial that will involve two sub-studies. One sub-study will investigate outcomes of the treatment in patients hospitalized with severe disease, but who are not in the intensive care unit, while the other will focus on patients in the ICU.
Researchers will being enrolling patients into the clinical trial once the U.S. Food and Drug Administration approves an Investigational New Drug application. The trial will include 50 patients and take for week to four months to complete, depending on the availability of eligible patients.
Donors must have had a confirmed COVID-19 diagnosis made by a nose or throat swab. Anyone currently on immunomodulatory therapy, which suppresses the immune system, is excluded from the trial.
Participants in the first sub-study will be randomly assigned to either plasma therapy plus standard of care or they will just received standard of care. The second sub-study will compare plasma therapy plus standard of care to the results of an National Institutes of Health study on remdesivir.
Research on convalescent plasma therapy also is ongoing nationwide. The National COVID-19 Convalescent Plasma Project, created by physicians and scientists from 57 institutions in 46 states, is organizing research efforts, including a national donor registry, through its website, a hub of information for health care providers, patients and the general public.
Penn has undertaken various studies related to the coronavirus.
A Phase 3 trial on remdesivir, as well as a COVID-19 vaccine DNA trial are underway too. Researchers are also studying how the body learns to fight infections, including COVID-19, in their Blood Donor Protocol trial.