By DANIEL A. KITTREDGE
There is presently no vaccine or cure for COVID-19, and it remains uncertain when one might be developed – let alone widely available.
But Rhode Islanders now have a chance to participate in a dual study focused on what a local researcher calls “probably one of the most promising” treatments for the disease – and, in doing so, have a “profound impact on the course of this epidemic.”
“We’ve already had 200,000 people nationwide die of this disease. We are almost certain to have many thousands more die of this disease unless we can find and effective cure,” said Dr. Adam Levine, an emergency physician at Rhode Island Hospital and the lead local researcher on the study. “And so, this is one way that people in Rhode Island can help find that cure.”
The study involves the use of convalescent plasma treatment, in which antibodies in the blood of people who have recovered from COVID-19 are used to limit the severity of the illness in people who have been recently diagnosed – and, hopefully, to help prevent members of at-risk populations from becoming sick in the first place.
There are two separate components to the study – randomized controlled trials that Levine said come after promising observational studies in hundreds of hospitals nationwide.
“Both of these trials,” he said, “are looking to attack COVID in different ways.”
The first trial is focused on infection prevention – using antibodies, Levine said, “sort of like an immediate vaccine.”
People who have been diagnosed with COVID-19 and “gone through the full illness” develop antibodies that remain in their blood for “many, many months,” the doctor said. But antibodies take time to develop, and with the use of a traditional vaccine, it can take several weeks for them to do so.
Using antibodies taken from the plasma of people who have recovered from the coronavirus, Levine said, has the potential to “give people an immediate shot at those antibodies without having to wait several weeks for their body to build up those antibodies themselves.”
For the infection prevention component of the study, researchers are seeking participants considered at a “high risk of exposure to COVID-19” – for example, people who live in, or have had, close contact with someone who’s been diagnosed with the disease, or people who work in health care settings.
The second component of the study focuses on early treatment – essentially, using antibodies to reduce the severity of COVID-19 in people who have recently been diagnosed with the disease.
“Our goal,” Levine said, “is trying to prevent them from developing worsening disease that might land in the hospital or the ICU, or even worse.” Currently, he said, roughly a quarter of cases evolve beyond mild symptoms and require more intensive treatment. The hope is to bring that rate under 10 percent.
For the early treatment component of the study, eligible participants will have received a positive COVID-19 diagnosis within the prior five days. Participants must not have been hospitalized and must still be experiencing symptoms.
Prospective participants in both sides of the study, Levine said, can expect to undergo an eligibility screening followed by a visit to Rhode Island Hospital for orientation, the obtaining of consent and an initial blood draw.
Those selected will return for a transfusion – half receiving convalescent plasma, and the other half a placebo – as well as a small number of follow-up blood draws. Most of the follow-up for participants will be conducted by phone, the doctor said. Those selected to participate will also be eligible for compensation.
The promise of convalescent plasma in treating COVID-19, Levine said, is clear through both historical context and recent observations. In medicine, he said, there is a “long history of more than 100 years” in using the treatment successfully against other diseases.
Since the onset of the pandemic, he said, observational studies of the use of the treatment – overseen by the Mayo Clinic – have involved more than 50,000 hospitalized COVID-19 patients around the country. Those studies, he said, have provided “some hint” of effectiveness.
“From these observational studies, we know that the treatment is safe,” he said. “There were very few kind of side effects or adverse effects in the people receiving it.”
Of the new trials, he added: “This study that we have ongoing is really one of the first randomized controlled trials that’s going to be able to tell us definitively if this treatment works.”
As of early this week, Levine said the trials have signed up roughly 20 percent of the targeted number of participants.
Acknowledging the possibility of a new surge in COVID-19 cases locally as the winter months arrive – and saying researchers are prepared for that scenario – he urged Rhode Islanders who meet the eligibility requirements for the trials to step forward.
“People in Rhode Island generally want to do the right thing. They are very much believers in science, they are very much believers in this pandemic and want to see it ended,” he said. “And people in Rhode Island are doing their part as we’ve seen in terms of wearing masks in public, in terms of social distancing, and I really want to urge that participation in research studies like this is another way that people can do their part. Because if we have more people participating in this study, we can actually identify the cure for COVID much more quickly … It would help all of those future people who are infected with COVID.”
To contact Rhode Island Hospital directly regarding participation in the trials, call (401) 444-3813.
Prospective participants can also visit covidplasmatrial.org or call (888) 506-1199.