Tuesday, August 18, 2020

Organizing tests of drugs to treat, and vaccines to prevent, coronavirus

 Here's a story on some of the difficulties in drug testing: among the difficulties are that positive test results for infection are taking too long after testing to allow prompt treatment...

Clinical Trials of Coronavirus Drugs Are Taking Longer Than Expected  By Katie Thomas

Aug. 14, 2020

"Antibody trials sponsored by Regeneron and Eli Lilly are off to a slow start because of a dearth of tests, overwhelmed hospitals and reluctant patients."

...

"While much of the world’s focus has been on the race to create a coronavirus vaccine, new drugs could also help curb the pandemic by making the disease less deadly. Because drugs are typically tested in sick patients in smaller clinical trials, they can also be developed more quickly than vaccines.

...

"The fast-moving disease has presented opportunities and challenges for the researchers testing antibodies. As the number of infections mounted in states like Florida, Texas and Arizona, there was no shortage of patients who would be eligible for trials. But at the same time, the outbreaks overwhelmed the very hospitals that would be overseeing the studies.

...

"“That doesn’t happen when you’re setting up diabetes trials or cancer trials,” he said. “We’ve had investigators say: ‘Look, I’d love to do research, but I don’t have time to set up a new trial. I’ve got an I.C.U. full of patients.’”

...

"Both the Regeneron and Eli Lilly trials require giving the drug within three days of taking a positive test.

"But with turnaround times in some areas lagging for five days or more, keeping within those time frames has proved difficult."

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With conventional (non-challenge) vaccine trials, having a high level of infection is important, to allow the effectiveness of vaccine candidates to be tested.  So, Brazil (and the U.S.):

 Coronavirus Crisis Has Made Brazil an Ideal Vaccine Laboratory  By Manuela Andreoni and Ernesto Londoño  Aug. 15, 2020

"Widespread contagion, a deep bench of scientists and a robust vaccine-making infrastructure have made Brazil an important player in the quest to find a vaccine."

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"Some 5,000 Brazilians have also been recruited to support a vaccine trial conducted by AstraZeneca, a British-Swedish pharmaceutical company in partnership with Oxford University. An additional 1,000 volunteers in Brazil were recruited to test a vaccine developed by New York-based Pfizer.

"Researchers need countries with large enough outbreaks to assess whether a vaccine will work. Some volunteers are given the potential vaccine while others are given a placebo, but they have to be in a place where enough virus is circulating to test the vaccine’s efficacy.

"Brazil, where the virus has infected more than three million people, has clear conditions for these trials. And it will be the only country other than the United States to be playing a major role in three of the leading studies as an unparalleled quest for a vaccine has led to unusually fast regulatory approvals and hastily brokered partnerships."

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