Uncertainty as Potential Covid-19 drug flops at first clinical trial

Shows significant side effects on patients 

The first potential antiviral drug to treat coronavirus has flopped in its first randomised clinical trial.

According to draft documents published accidentally by the World Health Organization (WHO), the scientists and investors were  disappointed after putting in high  hopes for the  remdesivir.

The Chinese trial showed remdesivir — developed by California-based Gilead Sciences  did not improve patients’ condition or reduce the pathogen’s presence in the bloodstream. 

Researchers studied 237 patients, giving the drug to 158 and comparing their progress with the remaining 79. 

The drug also showed significant side effects in some, which meant 18 patients were taken off it.

The WHO said the draft document, which is undergoing peer review, was published early in error. 

“In response to WHO asking for information and studies to be shared early, a draft document was provided by the authors to WHO and inadvertently posted on the website and taken down as soon as the mistake was noticed,” it said. 

Gilead warned that the post included “inappropriate characterisations of the study”. 

“Importantly, because this study was terminated early due to low enrolment, it was underpowered to enable statistically meaningful conclusions.

“As such, the study results are inconclusive, though trends in the data suggest a potential benefit for remdesivir, particularly among patients treated early in disease.”

Gilead trading was briefly halted on the Nasdaq on Thursday after the shares fell sharply on the news of the results of the study, and ended the day down more than 4 per cent at about $77.78. 

The stock surged to a high of almost $84 last week on hopes for remdesivir, valuing the company at nearly $100bn.

Until now, evidence from the use of Gilead’s remdesivir on treating Covid-19 had relied on studies that did not meet the robust scientific standards of being randomised and having a control arm. 

There are multiple ongoing Phase 3 studies that are designed to provide the additional data needed to determine the potential for remdesivir as a treatment for Covid-19. 

These studies will help inform whom to treat, when to treat and how long to treat with remdesivir. 

The studies are either fully enrolled for the primary analysis or on track to fully enrol in the near future.