A new series of trials by The Johns Hopkins Hospital will help determine whether antibodies from people who have recovered from COVID-19 can help those who have either been recently exposed or diagnosed. While other antibody trials are underway for those who require hospitalization, this set of two studies looks at whether giving people antibodies can treat early-stage COVID-19 and prevent those exposed to it from catching it.
This is the first U.S. multicenter, double-blind, randomized clinical trial to assess the effectiveness of convalescent blood plasma as outpatient therapy.
Participants must have tested positive for COVID-19 no more than five days ago, still have symptoms and not have been hospitalized; or have been in close contact with someone with COVID-19 no more than three days ago and not have any symptoms. Trials are being conducted at Johns Hopkins and at Anne Arundel Medical Center in Annapolis, as well as other locations. Those interested in enrolling can call 888-506-1199, or visit www.covidplasmatrial.org to take the enrollment questionnaire.
Dr. Shmuel Shoham, associate professor of medicine at Johns Hopkins University and a congregant at both Temple Sinai and Ohev Sholom-The National Synagogue in Washington, is one of the researchers behind these trials. He spoke with the Baltimore Jewish Times about the trials and COVID-19 in general.
Let’s talk about the big picture first. What is your perspective on the declining local rate of COVID-19, and how might flu season change that?
There’s a lot of unknowns. People that studied respiratory viral infections predict that when people get indoor settings, you get more infections. Cooler seasons typically bring respiratory infections to Baltimore. That said, people have been taking precautions so it’s unclear if and how it will be different in the coming months.
How does this research differ from COVID-19 vaccines under development?
There’s two approaches to immunization.
One is active immunization, where a product is given to somebody and their immune system reacts and develops antibodies. That’s traditional vaccines.
Second, there’s passive immunization, where you give preformed antibodies to a person who has been exposed. That helps prevent or treat infection. This is an approach that is done with various infections. One that easily jumps to mind is if somebody is exposed to a possibly rabid dog, they get a shot of rabies immunity, and they also get the rabbis vaccine (an active immunization) so there’s longer-lasting immunization.
We do have passive immunization to COVID-19, through convalescent plasma of people who have survived coronavirus and have antibodies. That’s been used in tens of thousands of people already in in-patient environments.
But in the out-patient, what we’re using, there has not been treatment. It’s just not known whether it’s effective in the out-patient environment. That’s what we’re testing now.
If you choose to participate in these trials, what risks are there?
Anything you put in your body can cause side effects. These studies, whether it’s post-study or early treatment, participants will get plasma with a plasma with high antibodies, or plasma that has no antibodies. The major risk is they are getting a blood product which people can have an allergic reaction to or a transfusion reaction.
What we have learned in in-patients is it is incredibly safe, with a low rate of side effects. But it’s not zero. We anticipate less than 1% will have a negative reaction.
What will the next step be?
For the postexposure prophylaxis, so far 36 people across the U.S. have enrolled, and half in Baltimore. For the early treatment it’s been a little over 100. We’ve seen an uptick in enrollment in the past weeks, and we think the next two weeks will be pivotal in terms of getting closer to our target. Our target for post-exposure is about 500 patients. That having been said, we may be able to make some estimates with fewer people on whether it’s effective. That’s to be seen still. For the pretreatment, we’re looking for 600 people.
My definition of “all goes well” is if we get data that this proves whether this works or not. If we are able to do the study as accurately as possible and the results show plasma is effective in treating infection, then we can hand that information over to doctors, the FDA and patients, who can make the decision about what is right for them.
You can imagine different use scenarios. If there’s a transplant recipient who doesn’t have the confidence in a vaccine, they could use plasma on top of the vaccine. In the other extreme, if you have somebody who might have the plasma already and is in a group with higher risk outcome, then that person may choose with doctor to use plasma. In a third scenario, a 23-year-old triathlete could be transiently exposed and say it’s not worth the low risk and not take the plasma.
What do you wish people knew more?
I would say that we often feel very powerless. But there are things we can do, one can do, in their part of prevention, which is pretty clear. People can do their part in participating in trials to push our knowledge further for better recommendations. I’ve always thought there are three things to get us through this: kindness, [cooperation] and using science.