Gilead Sciences’ last-minute modification of the clinical design of remdesivir, an emerging treatment against the new coronavirus (COVID-19), is drawing keen attention, industry sources said Friday.
The trials of remdesivir are scheduled to end in May.
The most notable change occurred in the number of patients. The company increased the number of severe and moderate COVID-19 patients from 1,000 to 4,000 and changed the primary endpoints. The schedule for ending the study remained unchanged.
According to ClinitalTrials.gov, Gilead updated the clinical design of remdesivir on Thursday.
As announced in late February, the two phase-3 trials (trial name: NCT04292899, NCT04292730) are to test remdesivir in severe and moderate COVID-19 patients, including 75 severe patients and 120 moderate patients from Korea.
The NCT04292899 study focuses on severe patients, and the NCT04292730, moderate patients. The two studies will divide the patients into two groups -- group A for five-day remdesivir treatment, 10-day treatment, and standard care, and group B for extended remdesivir in addition to the 10-day treatment of remdesivir.
With the latest update, the number of severe patients was up from 400 to 2,400 in the NCT04292899 trial, and that of moderate patients from 600 to 1,600 in the NCT04292730 study. The part B group of the former trial also included patients with mechanical ventilators.
Gilead also changed the primary endpoints of the trials. The NCT04292730 study will evaluate the results of remdesivir treatment compared to standard therapy by a seven-point ordinal scale on Day 11, instead of Day 14. The NCT04292899 trial will assess the results by a seven-point ordinal scale on Day 14, instead of the percentage of patients whose fever and oxygen saturation are normalized by 14 days.
The pharmaceutical industry expressed various opinions about the revision of the clinical design of remdesivir.
Some said remdesivir might have failed to earn impressive results in the initially-set primary endpoint. In contrast, others noted that the change might strengthen the effect of the drug and widen the use of medicine for more patients.
When announcing the start of the trials, Gilead had said it would focus research more on Asian patients as a majority of COVID-19 patients occurred in Asia.
With the recent spike in confirmed patients in the U.S. and Europe, the change might aim to provide remdesivir for more American and European patients, observers said.
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