First coronavirus drug trial underway at UNMC
UNMC announced Tuesday that a doctor there is leading a clinical trial to test a drug to combat coronavirus — the first in the United States to evaluate treatment for
Dr. Andre Kalil, an infectious diseases specialist and professor of internal medicine who is in charge of the trial, provided more details during a news conference at noon today at UNMC/Nebraska Medicine.
A clinical trial will be conducted by UNMC/Nebraska Medicine to see whether the former Diamond Princess passengers who eventually arrived in Omaha with coronavirus will respond to a therapy developed for
could help treat them as well.
National health officials believe they could soon have an answer as to whether it works.
"I'm optimistic we will at least get an answer, if we do have a therapy," NAID Director Dr. Anthony Fauci said. "That's really a game-changer. Then, we could do something as an intervention for those who are sick."
The trial will begin at UNMC but eventually be conducted internationally, gathering participants from sites all over the world, Kalil said. The NIH team will go to different hospitals and sites to determine whether those who want to participate fit the requirements of the trial, he said.
Some patients will already be quarantined, he said. Those allowed in the trial have to be a little sicker than a mild disease — something beyond the common cold, he said. They must have tested positive for COVID-19 and have the virus already in the respiratory tract, he said.
"These are the patients who are going to require a more aggressive treatment — that's the goal of the trial," Kalil said.
The first 57 people to come to Omaha were from Wuhan, China — the
. They left quarantine at Camp Ashland two weeks after their arrival. None ended up testing positive for COVID-19.
Of the 14 cruise ship passengers sent to Omaha from Japan last week with symptoms, 12 have developed pneumonia-like symptoms, which made them a candidate for the drug therapy.
"In order to avoid all sorts of biases," he said, the study will be "double-blind," meaning doctors, nurses, and patients won't know what sort of medication the patient is receiving.
Those participating in the double-blind clinical trial will receive one injection every day, he said.
The adaptive design of the study means the team will seize on positive results and rotate successful medications into control and test groups in order to expedite effective treatments, Kalil said.
“A randomized, controlled clinical trial to evaluate the safety and efficacy of the investigational antiviral remdesivir in hospitalized adults diagnosed with coronavirus disease 2019 (COVID-19) has begun at the University of Nebraska Medical Center,” according to
The first trial participant, who volunteered for the trial, is an American previously quarantined on
that docked in Yokohama, Japan.
The announcement of a possible drug therapy came on the heels of an update from the Centers for Disease Control informing the American public to
"It's not so much whether it's a question of 'if it will happen' anymore, but more a question of exactly when it will happen," CDC Deputy Director Dr. Anne Schuchat said.