Dr. David Seder, chief of critical care at Maine Medical Center, says scientists are still “learning how to use the drug in the most effective way possible.” Brianna Soukup/Staff Photographer
Maine hospitals have received two shipments of a new anti-viral drug – with a third on the way – and have begun using it to treat COVID-19 in the most severely ill patients.
Research indicates that remdesivir has some effectiveness in shortening hospital stays for infected patients, but research is continuing to determine how potent it is in treating COVID-19. It works by preventing the replication of the novel coronavirus in the body, and one Maine researcher said it may eventually be used to keep less severe cases from getting worse.
The Maine Medical Center Research Institute and nine Maine patients are participating in a worldwide, 7,600-patient study of remdesivir that is wrapping up at the end of May.
The drug has been found to be safe and effective enough that the U.S. Food and Drug Administration gave it emergency authorization and recently began shipping it to state health departments across the country. Dr. Anthony Fauci, an infectious disease expert and part of President Trump’s coronavirus task force, touted the drug’s potential while cautioning that much more still needs to be learned.
Some news reports around the country say distribution has been uneven and not met demand, but Maine has so far received generous amounts of the drug.
Maine has received two shipments from the federal government so far with enough doses to treat 81 patients with a 10-day course of the drug. A third shipment, due to arrive soon, would have enough remdesivir for 40 additional patients.
Maine had 44 patients hospitalized statewide as of Tuesday, although not all would meet the criteria to receive the drug. Patients getting the treatment include those who are hospitalized and need assistance breathing, such as with a ventilator.
As a result, all patients who are eligible to take the medication and are hospitalized in Maine will have access to the drug, which is being administered intravenously.
Dr. Nirav Shah, director of the Maine Center for Disease Control and Prevention, said it’s too early to tell how well the drug is working in Maine patients. The first shipment arrived May 12 and the second shipment came on May 15, so patients who did not receive the drug as part of the Maine Med study have been taking the medication for a week or less.
“The drug has been used, but it’s too early to know what impact it might have had on any particular patient,” Shah said on Tuesday.
Dr. David Seder, chief of critical care at Maine Med, said he couldn’t divulge results as the study is still ongoing. He said scientists are still fine-tuning how to use the drug, and are still “learning how to use the drug in the most effective way possible.”
“Everyone is really glad that preliminary data from the clinical trials is favorable,” Seder said.
The initial distribution of the drug in Maine is enough for as many as 40 patients at Maine Medical Center in Portland, 25 patients at Northern Light Eastern Maine Medical Center in Bangor, 10 at Central Maine Medical Center in Lewiston and six at MaineGeneral Medical Center in Augusta. Shah said remdesivir could be sent to other hospitals as needed from those four Maine hospitals.
Remdesivir was originally developed for Ebola, but was repurposed for COVID-19 by Gilead Sciences, a California-based pharmaceutical company.
Early research shows the drug – so far – is more of a base hit than a home run.
A vial of the drug remdesivir is inspected in March at a Gilead Sciences manufacturing site in the United States. Given through an IV, the medication is designed to interfere with an enzyme that reproduces viral genetic material. Gilead Sciences via AP
The full study has not yet been published, but the National Institute of Allergy and Infectious Diseases released results showing that hospital stays among hundreds of patients who had taken remdesivir declined from an average of 15 days to an average of 11 days. The study was conducted with patients with more severe symptoms, those needing some form of breathing assistance – oxygen or mechanical ventilation.
Dr. Meghan May, an infectious disease professor at the University of New England, said the research is showing a modest but important improvement for hospitalized patients.
“A modest reduction in length of hospital stay is a really important thing,” May said, explaining that shorter hospital stays benefit patients and medical personnel, maintain hospital capacity and preserve protective gear.
But May said while she understands the need to start research with the most severe patients, what will be key is how remdesivir performs with non-hospitalized patients who have moderate or mild symptoms. Research with patients with milder symptoms is currently underway.
“Patients with severe symptoms (who) need assistance breathing, by the time they are receiving the drug, their bodies are already extremely compromised,” May said. “So it’s not shocking that we are not seeing it have a large effect.”
May said the anti-viral drug stops the virus from replicating, so research in patients with mild or more moderate symptoms may be more telling about its value to fight the disease.
“It’s not like an antibiotic that destroys the bacteria,” May said. “The drug stops the virus from replicating, but it does not destroy the virus that is already there.”
She said if remdesivir stops the virus in its tracks, and patients can start taking the drug while symptoms are mild or moderate, it may be more effective and give the body a better chance of fighting off a virus that is not yet widespread in the body.
If the drug proves to be more effective for those with milder symptoms, the next challenge would be to get the drug in pill form or in a shot at the doctor’s office, because it’s not feasible for widespread use as an intravenous drug, she said. It’s difficult to know how long that will take, but research is being prioritized and fast tracked.
Another study that is being launched will test patients who just take remdesivir versus patients who take remdesivir plus baricitinib, an anti-inflammatory drug currently used for rheumatoid arthritis.
The part of the original study that included patients taking a placebo was halted in late April after seeing patients with remdesivir benefit compared to those who received a placebo. All patients were administered the drug. May said it was the correct ethical decision even though from a scientific standpoint it would have been better to complete the study with the control group.
“We have a duty to act to protect people,” May said. “You don’t give a placebo if you know something is better that works.”
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