Tacoma’s MultiCare part of research into drug that shows promise in treating COVID-19
An antiviral drug that was one of the first to show some kind of promise in the battle against COVID-19 offered renewed hope Wednesday with some of its early trial results.
Local patients have contributed to some of this early research.
Antiviral drug remdesivir, originally developed to fight the Ebola virus, has been made available in trials happening through MultiCare Health System in Tacoma via Gilead Sciences, the drug’s developer.
No placebos are involved in the local trials.
Gilead Sciences on Wednesday announced that results from its Phase 3 trial of the drug in patients with severe COVID-19 showed that “patients receiving a 10-day treatment course of remdesivir achieved similar improvement in clinical status compared with those taking a 5-day treatment course.”
Gilead’s research was announced the same day as early results from the National Institute for Allergy and Infectious Diseases’ trial of more than 1,000 patients from multiple sites of hospitalized patients either receiving remdesivir or a placebo.
That trial showed patients recovering on average in 11 days, compared with 15 days for those in the placebo group.
Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Disease, on Wednesday said to reporters at the White House of the results: “The data shows that remdesivir has a clear-cut, significant, positive effect in diminishing the time to recovery.”
“What it has proven is that a drug can block this virus.”
Others warn caution about the drug, with a third study out of China not showing clear-cut benefits.
Gilead’s trials and Tacoma
Remdesivir gained early attention when Washington state’s first diagnosed patient was given the drug during his own hospital stay and subsequently recovered.
That patient’s case was later presented in the New England Journal of Medicine. The case also was featured as part of a recent PBS “Frontline” documentary on how Seattle had to respond rapidly to the pandemic before the rest of the nation was even aware of the virus.
MultiCare was able to take part in Gilead’s research of the drug, introducing it to patients in the trial starting March 17.
Dr. Vinay Malhotra, a physician and researcher with MultiCare’s Pulse Heart Institute and the MultiCare Institute for Research & Innovation, is the primary investigator for trials of the drug at the Tacoma-based health system.
On Wednesday, Malhotra told The News Tribune that of the 53 hospitalized patients treated so far with the drug, 28 had been discharged. Three have died.
Malhotra described the local patients who died as being in later stages of the disease.
In the federal study, death for the remdesivir patients was 8 percent, compared with 11.6 percent for the placebo group.
Eventually, it is hoped that other treatments will prove even more effective for later-stage patients.
“This is going to be one of the things in your toolbox,” Malhotra said.
For the early viral phase that involves cold symptoms such as cough, fever and muscle aches, “using the drug in that phase is fantastic,” he noted.
For the later, more lethal stage of COVID-19, which brings on intense inflammatory reactions, “what works at that stage may be something different or an additional component,” he said.
To that end, MultiCare also is involved in immunotherapy research, targeting cells to fight the virus in the initial phase, and ongoing trials for preventing lung injury using il-6 or TNF blockers, more commonly associated in treating inflammatory auto-immune disorders.
As for remdesivir, the monitoring of the patients continue for 28 days after treatment “to make sure they were safe at home,” Malhotra explained.
The experience has been unlike any research before. In a blog post on MultiCare’s site, Malhotra said: “Results of the trials have already begun to spread among the health care community across the globe in a matter of hours, something that has never happened prior to this pandemic.
“What used to take weeks to be published in a medical journal is now being shared almost immediately in phone calls and updates through the World Health Organization. As the first U.S. cases were over here, we have been able to advise investigators in New York on some of our early findings and what we see that might be working, to better help them treat their patients as they are a couple of weeks behind us.”
Gilead on Wednesday said a shorter course of the medication could be beneficial to hospitals, particularly as resources continue to be in short supply.
“The study demonstrates the potential for some patients to be treated with a 5-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” said Dr. Merdad Parsey, chief medical officer for Gilead Sciences, in Wednesday’s announcement.
“This is particularly important in the setting of a pandemic, to help hospitals and health care workers treat more patients in urgent need of care.”
Stretching available resources isn’t just a feature resting solely on remdesivir, as other work has shown.
MultiCare also is involved in taking plasma from COVID-19 patients who have recovered to treat sick patients as part of a larger Mayo Clinic expanded access program.
“For each patient who recovers, if they decide to donate,” Malhotra noted, “that is good enough to treat two to four patients.”
“We had four donors and they treated 13 patients,” he said.
The donations are collected by Cascade Regional Blood Services. “It’s all local and stays local,” Malhotra added.
On Thursday, a representative for CHI Franciscan told The News Tribune that the health system’s St. Joseph Medical Center also is participating in a remdesivir trial, currently with five participants.
A mix of caution among optimism
Despite the glowing reviews from Fauci and Gilead, not all of the research has been as optimistic about remdesivir’s potential.
Another study, conducted between Feb. 6, and March 12 at 10 hospitals in Hubei, China, was more circumspect in terms of success. Those results were published April 29 in the Lancet medical journal.
The researchers prescribed either remdesivir or a placebo to 237 patients. The study found that the drug “was not associated with a difference in time to clinical improvement.”
It added, “Although not statistically significant, patients receiving remdesivir had a numerically faster time to clinical improvement than those receiving placebo among patients with symptom duration of 10 days or less.”
However, “Adverse events were reported in 102 (66 percent) of 155 remdesivir recipients versus 50 (64 percent) of 78 placebo recipients. Remdesivir was stopped early because of adverse events in 18 (12 percent) patients versus four (5 percent) patients who stopped placebo early.”
The analysis did recommend further study with larger groups to look at the faster recovery rate in those treated earlier, and critics of the report agreed, telling The New York Times on Wednesday the China study was too small.
Others were skeptical of Gilead’s initial results offered without a control group and noted that the federal study still needed to be peer-reviewed.
But at a time when the world is still scrambling for medication to help deal with the pandemic, remdesivir is poised for more widespread use with FDA authorization.
Gilead’s CEO Daniel O’Day, in an interview with STAT health news website, said Wednesday: “From July on, we’re going to work very closely with the government and with health care systems to make sure that it’s accessible, that it’s affordable to governments. We’re going to make sure that access is not an issue with this medicine.”
This story was originally published April 30, 2020 at 5:00 AM.
