With schools reopening, the weather getting chillier and more people forced to spend time indoors, many wonder how this will impact the spread of COVID-19. In particular, the big question is, will there be a fall and winter surge?
According to current guidelines established by the Centers of Disease Control and Prevention, one must quarantine for 14 days if exposed to someone with the coronavirus. Those who actually have the virus must stay isolated for at least 10 days after symptoms first appear.
But what if there was the potential to short-circuit the virus immediately after exposure but before you were symptomatic? Or if there was a way to prevent those with mild symptoms from getting critically ill?
Physicians and researchers at the Johns Hopkins University School of Medicine are currently conducting a pair of COVID-19 clinical antibody trials for patients who have been exposed to the virus but do not exhibit symptoms, and for patients who have tested positive and have symptoms that have not required hospitalization.
These are the first multi-center, double-blind, randomized clinical trials in the nation to assess the effectiveness of convalescent blood plasma as an outpatient therapy.
Dr. David J. Sullivan, a professor of molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health, and Dr. Shmuel Shoham, an infectious disease specialist and assistant professor of medicine at the JHU School of Medicine, are leading the nationwide trials and looking for area participants to volunteer.
Jmore recently spoke with Dr. Shoham to learn more about who is eligible to participate in the trials and what the research could mean for the future of the pandemic.
Jmore: Can you explain what these two trials entail?
Dr. Shoham: We suspect plasma, which is the part of the blood that has antibodies, will be effective in preventing the development of the infection or stopping the progression of the infection. We are using plasma from COVID-19 survivors that have viral antibodies and regular plasma with no antibodies to test that theory.
Currently, we are working with two groups of people for two different trials. The first trial is looking at whether plasma can be used as a prophylactic or preventive treatment. For that one, we want to enroll people who don’t have any symptoms but were exposed to the virus within a three-day window.
The second trial is an outpatient treatment for those who have the virus. For that one, we are looking for people who tested positive within a five-day window and have symptoms that don’t require hospitalization. We are hoping people in the community will be a part of the study.
Right now, we have 130 people signed up, but we are looking for a total of 1,100.
What’s the purpose of these trials?
If we find out plasma is effective as a preventative treatment, there are diverse ways in which we can use it. For example, if you’re going to synagogue and find out someone at the service tests positive for COVID-19, those sitting around the infected person could get the plasma treatment to prevent themselves from getting the virus.
Or if you go to a wedding and someone at your table tests positive, theoretically, you could get plasma and prevent the virus. If found effective, this is a way to shut down the spread.
We have evidence from the 100,000 people who received plasma in the hospital that this is a safe treatment, but if plasma works as an early-stage treatment it can also start being used in outpatient settings.
What are the pros and cons of participating in the trial?
Taking part in this trial will help advance our knowledge about the virus. And for the person who gets the plasma with COVID-19 antibodies, there’s a chance they could be protected from the virus all together.
That being said, we are using a blood product, meaning this is a low-risk, not a no-risk, procedure.
For those who want to participate, we bring in the patient to check their blood type, the following day we do the transfusion and then there are a few follow-up visits over the course of a 90-day period.
We are all hoping for a vaccine. Why are these trials needed?
An effective vaccine will be great. But there are certain populations of people who may not respond to the vaccine, so it’s important to have this crowdsourced material available in the event of a vaccine shortage or for those who get the vaccine but also still get sick.
Plasma could also be an option for transplant patients or patients undergoing chemotherapy who may not have a good response to a vaccine. If plasma works as a preventive and/or outpatient treatment, there are a lot of situations where it will be complimentary to a vaccine.