By JoNel Aleccia
APRIL 6, 2020
For 10
days last month, they lay in side-by-side isolation units in a Seattle-area
hospital, tethered to oxygen and struggling to breathe as the coronavirus
ravaged their lungs.
After
nearly 52 years of marriage, that was the hardest thing: being apart in this
moment, too weak to care for each other, each alone with their anxiety and
anguish.
“I
worried about my husband a lot,” recalled Josie Taylor, 74, who fell ill a few
days before George, 76. “Yes, I was concerned about me, but I was more
concerned about what was going to happen to him.”
Despite
their personal uncertainty, when a doctor approached the Taylors at their
bedsides to ask if they would consent to join a study of an experimental drug
to help experts learn to treat the devastating infection, each agreed.
“My
answer was absolutely yes,” Josie said. “My feeling was anything I can do to
help. Even if you’re stuck in an isolation room, this is affecting so many
people and we have to do everything we can.”
In late
March, the Taylors were discharged from EvergreenHealth medical center, heading
home a few days apart. They returned to their tidy white house in Everett,
tired, worn — and wondering if the clinical trial they had joined is the reason
they survived the deadly disease.
The
couple are among the first patients in the U.S. to recover from COVID-19 after
agreeing to participate in a National Institutes of Health randomized controlled trial of
remdesivir, an antiviral drug made by Gilead Sciences that once aimed to treat
another infectious disease, Ebola.
The
study is part of a surge in efforts to beat back the virus that as of Sunday evening had
sickened more than 337,000 people in the U.S. and led to more than 9,600 known
deaths.
“You
pray that you got the drug,” said Josie. “The fact that we both recovered so quickly?
You hope that’s the reason why.”
But
neither the Taylors nor Dr. Diego Lopez de Castilla, the 41-year-old physician
heading the trial at the Kirkland, Washington, hospital, know now whether the
couple received injections of remdesivir — or an identical-looking placebo.
Nor do
they know whether the investigational drug, designed to stop the virus from
replicating, is effective at halting the disease. There are a half-dozen studies in
progress across the globe testing remdesivir as a COVID-19 treatment.
At the
same time, more than two dozen Phase 3 clinical trials are recruiting
participants to study interventions to prevent or treat COVID-19. They range
from a tuberculosis vaccine being
tested on health care workers to a cancer drug that
could prevent the deadly fluid buildup occurring in the lungs of COVID-19
patients.
Other
drugs, including those used to treat rheumatoid arthritis and even gout are being
tested to see if they reduce the body’s inflammatory response to the infection.
A few studies aim to confirm whether treatments touted by President Donald Trump,
the antimalarial drugs chloroquine and hydroxychloroquine, are indeed effective
against COVID-19.
If any
of the trials show overwhelming evidence of benefit or harm, they could be
called off, with the drug in question accelerated to general use or halted.
So far,
no drug appears to be a certain treatment for COVID-19. Early results regarding
remdesivir are expected in late April. Officials with the World Health Organization and
many media accounts have suggested the treatment could hold promise. But it’s
too soon to say, said Lopez de Castilla.
“I
don’t think we have enough data to be commenting,” Lopez de Castilla said. “I
think it’s very premature. We’re still enrolling patients in the trial.”
Lopez
de Castilla is steering clear of the political turmoil that has surrounded
remdesivir and Gilead. The firm in March sought and received federal Food and
Drug Administration approval for so-called orphan drug designation,
but then asked the agency to rescind the designation after critics accused
company officials of unfairly seeking a lucrative monopoly for the drug.
Orphan
drug designation gives a manufacturer seven years of market exclusivity, a
period that essentially bars competition. Consumer advocates criticized the
designation because orphan drug status is aimed at products that target rare
diseases, those that affect 200,000 people or fewer. Gilead received the status
when U.S. cases were still hovering near 40,000 but were expected to rise far
higher.
In the
past two weeks, Gilead officials announced that, because of “overwhelming demand,” the
company would no longer provide the drug on an individual compassionate-use
basis to patients not enrolled in clinical trials and was shifting to a
broader-access program.
For
now, Lopez de Castilla is focused on the science, working to follow strict protocols
set by the National Institute of Allergy and Infectious Diseases study expected
to enroll 440 patients across 75 sites.
The
double-blind trial calls for participants to receive the active drug or placebo
for 10 days, and then to evaluate how they do based on a scale that moves from
fully recovered to death. The drugs are given free to hospitals and trial
patients. In a public letter March 28, Gilead chief executive Daniel O’Day
pledged that the company would work to “ensure affordability and access.”
Since
Feb. 21, 40 U.S. sites have joined the Adaptive COVID-19 Treatment Trial, with Lopez
de Castilla’s team enrolling among the most patients so far: at least 20 as of
April 1.
“We are
a community hospital,” he said. “Although we don’t have all the resources that
bigger hospitals have, we do have amazing people here.”
Still,
it hasn’t been easy. For weeks, EvergreenHealth was at the epicenter of the
U.S. outbreak, treating dozens of patients from the Life Care Center nursing
home in Kirkland, where nearly 40 patients have died. Overall, the hospital has
treated nearly 300 COVID-19 patients since Feb. 28.
The
patients enrolled in the trial are among the sickest, Lopez de Castilla said.
They’re those who are moderately to critically ill, including some who are
unconscious and on ventilators. Obtaining consent to participate in a clinical
trial from patients or families grappling with an emergency has been “very
challenging,” he said.
“One of
the challenges is how to enroll a patient who is already intubated,” he said.
“We do this through a family member, someone who can make medical decisions for
the patient.”
It can
take hours to explain the procedure, describe the side effects — which could
include gastrointestinal problems or elevated liver enzymes — and provide
detailed information so the patient or their legal representative can make an
informed decision.
Patients
must understand that they could receive an unproven therapy, he said. And they
need to know that, because the trial calls for half of the patients to receive
the drug and half to receive a placebo, there’s a 50% chance they won’t
actually receive the active drug.
One
barrier has been that the trial paperwork is available only in English, which
is not the first language of some patients. EvergreenHealth is working with the
NIH to create at least one translation in Spanish.
Overall,
about half of the patients Lopez de Castilla approached have said no.
For
Josie Taylor, a former second-grade teacher who volunteers for social causes,
the decision to join the trial was easy. “It does have to be studied,” she
said. “It can’t be a knee-jerk reaction of ‘Take any medication, without
knowing what the results will be.’”
She and
her husband, a retired banker, fell ill in early March, just weeks after moving
from their home of 40 years to a new community 30 miles north of Seattle. Josie
got sick first.
“I went
to the grocery store and came out, loaded the stuff in the car and realized I
was very short of breath — weirdly so,” she recalled.
She ran
a fever that night, called her doctor and went to the emergency room the next
morning, where she was quickly placed in isolation.
George
Taylor is a Vietnam War veteran who was affected by the defoliant Agent Orange
used in that war. He has multiple health problems, including prostate cancer,
heart disease and Parkinson’s disease. Within a couple of days, he also fell
ill.
George
was sent to the ER and then to an isolation room — next to his wife’s. For more
than a week, they were both seriously ill, on oxygen, uncertain about the
future. “It was 10 or 11 days,” Josie said, adding wryly: “Honestly, you lose
track when you’re having fun.”
Contracting
the novel coronavirus has been scary. But they were heartened by the support of
family, friends, even people they barely knew. “I came home to a brand-new
place with brand-new neighbors and our yard had been mowed and edged,” Josie
said.
Now
that they’re both home, the Taylors are gradually getting back to normal. Josie
still speaks slowly, pausing to catch her breath between words. She said she
hopes her experience underscores the seriousness of the crisis.
“I’m
hoping and praying that this drug helps a lot of people,” she said. “It’s not
an old person’s issue. It’s an every person’s issue.”
JoNel
Aleccia: jaleccia@kff.org, @JoNel_Aleccia
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