NEW ORLEANS — The quest for an Ebola treatment is picking up speed. Federal officials have unveiled a plan to simultaneously test multiple drugs in an umbrella study with a single comparison group to give fast answers on what works.
“This is novel for us” and is an approach pioneered by cancer researchers, said Dr. Luciana Borio, head of the U.S. Food and Drug Administration’s Ebola response effort. “We need to learn what helps and what hurts” and speed treatments to patients, she said.
She outlined the plan Wednesday at an American Society of Tropical Medicine and Hygiene conference in New Orleans. Thousands of scientists have crowded into day and night sessions on Ebola, which has killed 5,000 West Africans this year.
There is no treatment for Ebola, but experimental ones such as ZMapp have been tried on a few patients, and scientists are eyeing some others that were developed for different conditions but might also fight Ebola.
“There’s this tremendous urge to want to give people these experimental therapies,” but it’s crucial to make sure they don’t do harm, said the FDA’s Dr. Edward Cox.
Everyone in the umbrella study would get supportive care, such as intravenous fluids, then would be assigned to receive one of several drugs or be in a comparison group. That’s needed because without one, there’s no way to know whether any problems or deaths are from the drug or the disease, Cox said.
Instead of waiting until a certain number of patients is treated to look at results, as is usually done, researchers will monitor results as they come in, pairing each person on a drug with someone from the comparison group to see whether a pattern can be detected.
The National Institutes of Health developed this “learn as you go” plan “to allow a winner to be declared very early,” Cox said.
He said the FDA could not name the drugs being considered but said a meeting next week with various companies should crystallize the plans.
At least 30 scientists were barred from the conference because Louisiana state officials told attendees to stay away if they had traveled to certain West African countries or had contact with an Ebola patient in the last 21 days, Ebola’s maximum incubation period.
