Could a century-old medical technique prove valuable in the fight against the coronavirus? New evidence suggests that this well-established therapeutic tool known as convalescent plasma therapy may indeed have the power to save lives.
What Is COVID-19 Blood Plasma Therapy?
Known as convalescent plasma therapy, this treatment was first used in 1892 to treat diphtheria. It’s a relatively simple therapy that treats infected patients with blood plasma from previous patients who developed antibodies to a specific virus. This makes it possible to boost the immune systems of infected patients and create passive immunity.
“It’s using someone else’s pre-formed immunity when the patient does not have immunity,” explained Dr. Rebecca Haley of Bloodworks Northwest, one of the blood centers participating in a national study on convalescent plasma for the treatment of COVID-19.
Convalescent plasma therapy was used in the 1920s to battle scarlet fever and in the 1960s to treat pertussis. More recently, doctors used convalescent serum to treat Ebola virus, SARS, and MERS. The FDA believes that convalescent plasma is “promising”, but its safety and efficacy must be thoroughly studied specifically for COVID-19 treatment.
FDA Guidance on COVID-19 Convalescent Plasma
On May 1, the FDA issued guidance on investigational COVID-19 convalescent plasma. According to these guidelines, doctors are permitted to administer or study the use of COVID-19 convalescent plasma in the following ways:
- Clinical trials
- Expanded access
- Single patient emergency Investigational New Drug Applications (IND) request
Many hospitals, such as Medical University of South Carolina (MUSC), have joined Mayo Clinic’s Expanded Access Program (EAP) to provide convalescent plasma therapy to infected patients. Physicians are encouraging people who recovered from COVID-19 at least 28 days ago to donate plasma and potentially save another life.
“I’m hoping that some of my plasma ends up in another patient who is suffering from COVID-19, and this could potentially save their life,” explained bioengineer Elizabeth Schneider, a former coronavirus patient from Seattle, Washington.
Current Convalescent Plasma Therapy Clinical Trials
More than 75 clinical trials are currently pending to explore the effects of convalescent plasma therapy on COVID-19 patients. These are just a few of the clinical trial studies in progress:
- COVID-19 Convalescent Plasma for Mechanically Ventilated Population
- Convalescent Plasma for COVID-19 Clost Contacts
- Convalescent Plasma vs Placebo in Emergency Room Patients with COVID-19
- Convalescent Plasma for the Treatment of COVID-19
Of the more than 75 studies in progress, 15 of them have reached Phase 3 or 4. For example, the clinical trial titled “Convalescent Plasma Collection and Treatment in Pediatrics and Adults” is sponsored by West Virginia University.
“This is a prospective study, involving contacting potential plasma donors and the use of their plasma to help fight off infections of those suffering from COVID19,” the clinical trial summary states. “This study will include up to 240 participants potentially receiving convalescent plasma and up to 1000 potential donors.”
Until these clinical trials conclude and report official results, doctors and patients can continue using the FDA’s expanded access and emergency use programs to capitalize on this promising treatment.
Sources
- https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma
- https://clinicaltrials.gov/ct2/show/NCT04376034?term=convalescent+plasma&cond=COVID-19&phase=23&draw=3&rank=12
- https://clinicaltrials.gov/ct2/results?term=convalescent+plasma&cond=COVID-19&age_v=&gndr=&type=&rslt=&Search=Apply
- https://www.sciencedirect.com/science/article/pii/S1473050220300793
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4781783/
- https://web.musc.edu/about/news-center/2020/04/24/musc-health-provides-plasma-transfusion-to-covid-19-patients