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June 2, 2020

Remdesivir shows clinical improvement in Phase III Covid-19 trial

Gilead Sciences has reported positive top-line data from the Phase III SIMPLE clinical trial of remdesivir in hospitalised patients with moderate Covid-19 pneumonia.

Gilead Sciences has reported positive top-line data from the Phase III SIMPLE clinical trial of remdesivir in hospitalised patients with moderate Covid-19 pneumonia.

The trial assessed five-day and ten-day courses of the drug in combination with standard of care, compared to standard of care alone.

According to the data, patients on the five-day remdesivir course were 65% more likely to have clinical improvement at day 11 compared to those on the standard of care treatment.

The company added that the ten-day treatment course of remdesivir was also more likely to improve clinical status versus standard of care, trending toward but not achieving statistical significance.

Investigators did not report any new safety signals with remdesivir across either treatment group. The drug was also generally well-tolerated.

Gilead Sciences chief medical officer Merdad Parsey said: “Today’s results showed that when treating moderate disease, a five-day course of remdesivir led to greater clinical improvement than standard of care, adding further evidence of remdesivir’s benefit to previously released study results.

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“The National Institute of Allergy and Infectious Diseases’ placebo-controlled study showed that remdesivir enabled more rapid recovery and that earlier treatment improved clinical outcomes.

“Our SIMPLE-Severe study showed that when treating patients with severe disease, five days of remdesivir led to similar clinical improvements as a ten-day course.”

The SIMPLE trial involved hospitalised Covid-19 patients with evidence of pneumonia without decreased oxygen levels.

Primary endpoint was the clinical status at day 11, including hospital discharge,  increasing oxygen levels, ventilatory support and death. The secondary objective was the rate of adverse events in each remdesivir group compared to standard of care.

In April this year, the National Institute of Allergy and Infectious Diseases reported preliminary data from a clinical trial, which showed that remdesivir led to faster recovery in Covid-19 patients.

The drug received approval in Japan to treat Covid-19, while the US Food and Drug Administration (FDA) awarded an emergency use authorisation for treating hospitalised patients with severe Covid-19.

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