https://www.medscape.com/viewarticle/928472#vp_2
Bigger, Faster Trials Planned
In perhaps the fastest-moving, large prophylaxis trial, researchers at Duke University are leading a $50 million collaboration across hundreds of American health care systems, which will test 15,000 volunteers. Half the health care workers will take hydroxychloroquine, and half a placebo. Other drugs could be added to the study if they prove promising for preventing or lessening infection, says Adrian Hernandez, the trial's principle investigator.
The trial is being launched by PCORnet®, the National Patient-Centered Clinical Research Network, a network of health care systems that have come together over the last few years to plan and conduct research trials. Although the collaboration predates COVID-19 by nearly five years, this is precisely the kind of situation it was designed to address, says Hernandez, adding that he hopes the network will soon be able to test COVID-19 vaccine candidates as well.
The team is planning to begin registering participants as soon as this week, he says, with dosing to begin in the middle of April and lasting about 10 weeks. Hernandez says he expects to publish the first results this summer.
Clinical research of this size usually takes several years, with another year or two before the results are published. But there has never before been so much at stake. "The motivations are extreme. People are moving mountains to make this happen." He says he hopes that innovations made during this crisis will have a lasting impact on the research process.
"It'll be a new model, if it's successful," he says. "Speed is of the essence. We need to get answers before things get worse with our health care workers."
In France, researchers are running a trial with 1,200 health care workers to test prophylactic use of hydroxychloroquine or a combination of two HIV drugs, Lopinavir and Ritonavir, which failed as a treatment in people with severe COVID-19 infections but may work as prevention. It is expected to take 6 months.
In a 40,000-person trial led by the University of Oxford in England, participants in Asia will receive chloroquine or a placebo, and in Europe, hydroxychloroquine or a placebo. That trial is expected to take a year.
Robert Salata, chairman of the department of medicine at UH Cleveland Medical Center, is including 4,500 patients in his trial of an antiseptic that health care workers will spray into their mouth three times a day.
"It's pleasant tasting and it's really safe," says Salata, also a professor of medicine, epidemiology and international health at Case Western Reserve University, in Cleveland. The antiseptic, called ARMS-I, made by ARMS Pharmaceutical of Cleveland, is already present in lower concentrations in some mouthwashes, he says.
Salata's team studied the same antiseptic in 100 people during flu season and found that it decreased the number of upper respiratory infections, and if patients got sick, they recovered faster. The antiseptic has also proved useful in bone marrow transplant patients who have weakened immune systems, he says.
He is now recruiting patients and expects the trial to take about 4 months, 6 for the results. It is not yet fully funded, he says, but he hopes to raise more, and the company that makes the antiseptic has promised to make up the difference.
"If this works, it could be a game-changer, so we want to move on it quickly," Salata says.
