U.S Ends Hydroxychloroquine Clinical Trial - COVID-19 Clinical Trial
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U.S Ends Hydroxychloroquine Clinical Trial

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    Hydroxychloroquine, the malaria drug once believed to be a game changer in the fight against the coronavirus, has reached the end of the road.  

    The World Health Organization (WHO), U.S National Institutes of Health (NIH), and generic hydroxychloroquine maker Novartis have all ended their clinical trials of the experimental COVID-19 in rapid succession, citing lack of benefits for patients.  

    How Did Hydroxychloroquine Hit the Fast Track in March? 

    Hydroxychloroquine quickly earned a spot in the center of the spotlight as the coronavirus pandemic emerged and experts desperately sought to find an effective treatment option for hospitalized patients.   First approved for medical use in the U.S in 1955, hydroxychloroquine  

    What Did Clinical Trials Reveal? 

    The beginning of the end appeared on the horizon for hydroxychloroquine after chief investigators of the RECOVERY Trial, Professors Peter Horby and Martin Landray of Oxford University, announced their assessment of the experimental drug on June 4.  

    “We have concluded that there is no beneficial effect of hydroxychloroquine in patients hospitalized with COVID-19. We have therefore decided to stop enrolling participants to the hydroxychloroquine arm of the RECOVERY Trial with immediate effect.” 

    The RECOVERY Trial found no significant difference in mortality, with the death of 25.7% of patients treated with hydroxychloroquine compared to 23.5% of patients treated with usual care. As Horby and Landray explained, “These data convincingly rule out any meaningful mortality benefit of hydroxychloroquine in patients hospitalized with COVID-19.” 

    Shortly after the RECOVERY Trial ended its exploration of hydroxychloroquine, the FDA revoked its emergency use authorization for hydroxychloroquine against COVID-19.  

    It didn’t take long for other organizations to follow the lead of Oxford University and the FDA. A statement from the NIH on June 20 explained that, “while there was no harm [caused by hydroxychloroquine], the study drug was very unlikely to be beneficial to hospitalized patients with COVID-19.” The NIH echoed findings of the RECOVERY trial, namely that “this drug provided no additional benefit compared to placebo control for the treatment of COVID-19 in hospitalized patients.” 

    Around the same time, Novartis, the maker of the generic drug, also announced its decision to halt its clinical trial.  

    “The recruitment challenge facing our hydroxychloroquine trial has made it unlikely that the clinical team will be able to collect meaningful data in a reasonable time frame to determine the efficacy of hydroxychloroquine in treating patients with COVID-19,” Novartis explained.  


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