I think I can speak for most people when I say that viable treatments and vaccines are desperately needed at this point to overcome the COVID-19 global pandemic. Not only that COVID-19 has taken so many lives across the globe, the societal, public health and financial ramifications will be with us for years to come. Thus far, for patients who have been exposed to SARS-CoV-2, there are no proven options for prophylaxis, and an FDA approved therapy for those who actually develop COVID-19 does not exist.1 Convalescent plasma is the “plasma that is collected from individuals following resolution of infection and development of antibodies”.1 According to Bloch, et al. (2020), the administration of antibodies through transfusion of convalescent plasma may in reality be the only short-term option for immediate immunity.
Given the lack of approved treatments, some doctors are leveraging convalescent plasma therapy as an experimental treatment.2 To that extent, FDA issued guidance with recommendations to health care practitioners and clinical investigators on the handling of convalescent plasma.3 Since this is considered an investigational product at this point, as it has not been approved by the agency, health care providers are to obtain “COVID-19 convalescent plasma from an FDA-registered blood establishment”.3 It is worth noting that studying the safety and efficacy of COVID-19 convalescent plasma in clinical trials is a worthwhile endeavor given the promising potential for this as a possible treatment.3
In spite of the promising results, and the low risk associated with convalescent plasmas a potential treatment, such therapies still carry some risks including:
- Allergic reactions
- Lung damage and difficulty breathing
- Transmission of infections, including HIV and hepatitis B and C2
However, the Mayo Clinic notes that the risk is very low due to the fact that “donated blood must meet certain requirements outlined by the FDA. Before donated blood can be used, it must be tested for safety. It then goes through a process to separate out blood cells so that all that’s left is plasma with antibodies”.2
From the regulatory standpoint, FDA’s guidance document for investigational COVID-19 convalescent plasma outlines three pathways for access to convalescent plasma as follows:
- Under an emergency use investigational new drug (IND) application.
- A traditional pathway to apply for an IND to support research (e.g., for clinical trials).
- A government-led initiative provides expanded access of convalescent plasma to participating institutions under a master treatment protocol.1
There are at least five active clinical trials that are currently underway to evaluate the use of convalescent plasma for the prevention and treatment of COVID-19.1 In addition to the clinical trials, “studies are being designed to collect and mine data from emergency (i.e., compassionate) use of convalescent plasma or expanded access treatment”. 1 Although the safety and efficacy for this potential treatment has not been verified as of yet, there is substantial evidence of advantages of similar treatments for viral infections that serves as a precedent for such an approach.1 Nonetheless, it is imperative to confirm the safety and efficacy via controlled trials to 2ensure evidence-based decision making.
If you are interested in learning more about this topic, EMMA International has the expertise to help you navigate the regulatory landscape. Contact us at 248-987-4497 or email email@example.com to get connected to our regulatory experts!
1Bloch, E. M., Shoham, S., Casadevall, A., Sachais, B. S., Shaz, B., & Winters, J. L. (2020). Deployment of convalescent plasma for the prevention and treatment of COVID-19. Journal of Clinical Investigation.
2Clinic, M. (2020, May 20). Convalescent plasma therapy. Retrieved from https://www.mayoclinic.org/tests-procedures/convalescent-plasma-therapy/about/pac-20486440?mc_id=google&campaign=10379200728&geo=9016792&kw=%2Bcovid-19%20%2Bplasma&ad=444183766709&network=g&sitetarget=&adgroup=102350354599&extension=&target=kwd-9483075813
3FDA. (2020, May 1). Recommendations for Investigational COVID-19 Convalescent Plasma. Retrieved from https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma