The Trump administration’s decision to authorize the use of a blood plasma treatment for COVID-19 without clear evidence that it works could thwart efforts to better understand the benefits of the therapy.
Several clinical trials are examining the use of so-called convalescent plasma for COVID-19, but none have been completed and results are not expected for at least several more weeks.
Some of the studies are struggling to attract participants because of programs that give patients a safer path to therapy and a way to avoid the risk of ending up with a placebo in a clinical trial. Researchers fear that Sunday’s decision by the Food and Drug Administration to issue an emergency waiver will make it harder for patients to participate in clinical trials and get a more definitive picture of whether convalescent plasma actually works to treat COVID-19 and as it does.
Plasma is the liquid portion of the blood. Convalescent plasma collected from those who have recovered from the coronavirus contains antibodies that some researchers say could help patients who have recently been diagnosed with COVID-19. President Donald Trump has called the therapy “something very special.”
Political Controversy
The emergency use authorization followed accusations by Trump that US regulators had been delayed to reduce his chances of re-election. Some top US health officials were reported to caution against issuing an authorization until researchers could collect more data.
Antibodies are one of the main compounds that fight infections produced by the immune system. They remain in the blood of patients who have recovered from illness, and their use to help someone else fight infection is an old idea. Convalescent serum was used to combat the 1918 influenza pandemic. The first Nobel Prize in Physiology or Medicine was awarded to Emil von Behring in 1901 for his work in the study of serum therapy for diphtheria.
However, many questions remain about what convalescent plasma is and who should receive it. People sick with a pathogen produce their own antibodies; Determining which antibodies actually fought a disease is a difficult task for researchers. Doctors also want to make sure that the introduction of foreign antibodies does not make people sick.
Data Delay
Two trials conducted by researchers at Johns Hopkins University have also struggled to attract patients to participate, delaying the delivery of results. Researchers are investigating the potential of plasma to prevent contracting the virus and its ability to help in the early stages of infection.
The studies may produce preliminary data in October, Shmuel Shoham, an infectious disease cancer expert who is co-leading the studies, said in an interview.
The Johns Hopkins researchers would like to enroll 1,100 people in total in the trials, but so far they have enrolled 60, Shoham said. Recruitment has been difficult at some of the 30 sites in the country. The virus has disproportionately affected Black and Latino people, who are often unwanted or do not participate in clinical trials.
