NIAID primate study supports remdesivir for treating COVID-19

Gilead Sciences’ COVID-19 treatment candidate remdesivir has generated controversy as the company speeds up R&D amid questions about whether early results from human trials of the drug have adequately proven it works. Now, scientists at the National Institutes of Health and Gilead have published results from an animal trial of remdesivir that they believe will help the scientific community better assess the drug’s power to combat the virus.

The trial of human COVID-19 patients, managed by Frederick National Laboratory for Cancer Research, includes 66 treatment sites. Early results from one of those sites, the University of Chicago Medicine, suggest that remdesivir treatment was associated with rapid improvement in fever and respiratory symptoms and that nearly all patients were discharged within a week of treatment. Those findings, reported by STAT, have generated excitement from the public but concern from scientists wary of basing conclusions on incomplete data. Complete findings from phase 3 trials are not expected until late May.

In the animal trial, which included 12 rhesus macaque monkeys with COVID-19, early remdesivir treatment reduced symptoms of the disease and lung damage, the authors reported in a study posted on bioRxiv. Six macaques were treated with the drug, while the others were untreated. Seven days after the start of the study, the macaques treated with remdesivir were significantly healthier than those in the control group, according to the study authors, the majority of whom are affiliated with the National Institute of Allergy and Infectious Diseases.

The animal trial was designed to replicate the remdesivir dosing schedule that’s being tested in the ongoing clinical trial. So the macaques received an intravenous dose of the drug 12 hours after being infected with COVID-19, followed by one booster dose per day for six days. At the end of the week, all six untreated animals were showing breathing difficulties. Only one of the treated macaques had breathing problems, which were mild, they reported.

“Data from clinical trials in humans are pending, but our data in rhesus macaques indicate that remdesivir treatment should be considered as early as clinically possible to prevent progression to severe pneumonia in COVID-19 patients,” the researchers wrote.

Read more: https://www.fiercebiotech.com/research/covid-19-new-animal-data-backs-up...

Read the rhesus macaque trial: https://www.biorxiv.org/content/10.1101/2020.04.15.043166v1.full.pdf

Read the STAT report on the human trial: https://www.statnews.com/2020/04/16/early-peek-at-data-on-gilead-coronav...