For the doctors treating the hundreds of patients who are hospitalized for COVID-19 in Virginia, there’s no playbook. The disease that has spread rapidly across the world – killing hundreds in the state and more than 200,00 worldwide – has no known treatment, so COVID-19 has presented a unique challenge to the doctors faced with saving lives against a mostly-unknown enemy.
But, in an effort to discover treatments, medical researchers in the state have dropped everything to ramp up experimental clinical trials that many be the patients’ best hope of recovery.
When Dr. Antonio Abbate, speaks with patients about the possibility of joining a clinical trial, he’s used to standing next to the patients, holding their hands and looking into their eyes.
Joining a clinical trial means he or she is volunteering to receive an experimental treatment that has not been proven to be effective. Abbate, the medical director of the clinical research unit at VCU Medical Center, has to tell them about the possible benefits and risks.
But in the new reality where physical proximity means greater danger for health care workers and patients alike, he’s had to get accustomed to having those conversations by video chat.
As of Friday, VCU had enrolled 38 people in trials to test two drugs, remdesivir and sarilumab.
“Everybody stopped what they were doing and really focused on [COVID-19],” said Dr. F. Gerard Moeller, who chairs the committee at VCU that reviews new clinical trials.
Studies on two experimental drugs were approved in days rather than the usual weeks or months it would usually take, he said. Currently, the trials are only for people whose COVID-19 is serious enough for them to be hospitalized and doctors determine which trial to enroll a patient based on the specifics of the case.
“We’re not jumping steps, we’re just working nights and weekends to make things happen,” Abbate said, emphasizing the importance of not disregarding safety. “I am optimistic that we will have treatments within months. I’m just not sure which one it will be.”
Remdesivir is an antiviral drug that has not been approved, but has been used experimentally to treat Ebola and tested in animals with other diseases caused by different kinds of coronaviruses. The company that manufactures the drug, Gilead Sciences Inc., announced hopeful results on April 10 that the drug had shown improvement in 68% of a small group of 53 patients with severe complications of COVID-19 treated through a clinical trial.
But the World Health Organization accidentally published findings from a trial that took place in China that found no benefit from the drug, but the findings were inconclusive because the study was ended early, Stat News reported Thursday. Remdesivir is also being tested at clinical trials at HCA Henrico Doctors’ Hospital and the University of Virginia Medical Center.
Sarilumab is approved for treating rheumatoid arthritis and is focused not on fighting the novel coronavirus directly, but on calming an overactive inflammatory response to the virus that damages the body.
At UVA Medical Center, doctors specializing in infectious disease and critical care began looking at evidence for different potential therapies for COVID-19 before treating their first patient.
“We wanted to hit the ground running,” said Dr. Patrick Jackson, an infectious disease specialist leading the remdesivir trial at UVA.
Jackson said that many of his patients have been enthusiastic about participating in the clinical trial because they want to be part of the effort to find a treatment for COVID-19 that will help more people down the road. He’s hoping to have some initial results from the trial, which is being run at hospitals across the country lead by the National Institutes of Health.
On Monday, his team will begin the second phase of the trial that will include adding a different drug, baricitinib, which is an anti-inflammatory used to treat rheumatoid arthritis.
They also plan to start enrolling patients in additional studies soon, including another effort to reduce the body’s inflammatory response by using adult stem cells.
Another experimental treatment that is taking hold across the world is the use of convalescent plasma, which is taken from the blood of people who have recovered from COVID-19. The plasma contains antibodies that can help the immune system fight of the virus.
“There’s been a history of using the plasma of patients who have successfully recovered from a disease,” said Dr. Dennis Szurkus, Chief Medical Officer at HCA Henrico Doctors’ Hospital, which is participating in a study run by the Mayo clinic. “We’re hoping it will be highly effective.”
VCU Medical Center, Bon Secours hospitals and UVA Medical Center are also using the plasma treatment.
But in order for the hospitals to administer this treatment, they need blood donations from people who have recovered from COVID-19 and meet the criteria, which currently include having a positive test for the disease and being symptom free for at least 28 days, or symptom free for at least 14 days and have a negative COVID-19 test.
But as testing shortages have plagued the country, only 10% of the thousands of people who have reached out to the Red Cross hoping to donate over the last month met the eligibility criteria, according to a press release from the American Red Cross Friday.
To help streamline the process, last week, the Food and Drug Administration approved an antibody test that the Red Cross will roll out to screen donated plasma for COVID-19 antibodies. The Red Cross won’t be doing antibody testing for the general public. Those wanting to donate can learn more at redcrossblood.org/plasma4covid.
But even as researchers talk about the promise of quickly moving toward potential treatments, they’re careful to warn against disregarding scientific protocol.
“You want to do the best thing you can for that patient,” said Moeller from VCU’s clinical trial committee, explaining a physician’s temptation to try out multiple treatments on a patient. “At the same time, if you just throw everything at the patient without any evidence, you don’t know if what you did helped the patient … whether medications can be helpful or harmful … without controlled studies, we don’t know that.
The FDA has issued a warning against using hydroxychloroquine, an antimalarial drug that President Donald Trump has promoted as a possible treatment for COVID-19, outside of hospital and clinical trial settings because of possible side effects that could impact the heart.
“There’s a pressure to get treatments out there — as there should be,” said Jackson, from UVA. “But we also risk doing the wrong thing for patients … We take very seriously the principal of, first, do no harm. That’s why clinical trials like this are so important.”