In mid-March, the FDA expressed interest in evaluating if convalescent plasma taken from blood donated by people who have recovered from COVID-19 could shorten the length or lessen the severity of the virus. The agency now leads a cross-government initiative to facilitate the development of antibody-rich blood products.
The FDA claims that prior experience with respiratory viruses, and data from China, indicates that such products could be useful in the fight against COVID-19, and a recent article from the Journal of the American Medical Association (JAMA) shows potential.
The JAMA study documents the results of convalescent plasma transfusions for five patients with critical illness from COVID-19, all of whom had high viral loads and suffered acute respiratory distress syndrome (ARDS), requiring mechanical ventilation.
Convalescent plasma was administered to these patients 10-22 days after hospital admission. Body temperature normalized within three days for four out of the five patients, and their sequential organ failure assessment (SOFA) scores decreased, indicating a lower likelihood of organ failure. Furthermore, ARDS resolved in four patients after 12 days, with three patients weaned off ventilators after two weeks. Three patients were discharged, and the other two were in stable condition 37 days after the transfusion.
While this study and others like it show promise, they require evaluation in randomized clinical trials, as this case was an uncontrolled case study with a very small sample size.
However, the potential of studies like this is encouraging the FDA to facilitate access to convalescent plasma for treating COVID-19, using multiple pathways. This includes emergency investigational new drug applications (eIND). The FDA is proving healthcare providers information on how to submit eINDs to treat individual patients with convalescent plasma. Furthermore, the FDA is working with healthcare industry, academic, and government partners to develop and implement protocols surrounding convalescent plasma.
And finally, the FDA is encouraging those who have fully recovered from COVID-19 for at least two weeks to consider donating plasma, which could potentially help save lives. Potential donors are encouraged to visit the Red Cross online, or contact their local blood donor or plasma collection center.