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"The drug failed as a treatment for hepatitis and Ebola."
Remdesivir, an antiviral drug designed to treat both hepatitis and a common respiratory virus, seemed fated to join thousands of other failed medications after proving useless against those diseases. The drug was consigned to the pharmaceutical scrap heap, all but forgotten by the scientists who once championed it.
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etter statistically for those receiving five days of remdesivir but no different for those receiving 10 days of remdesivir. This oddity might be explained by serious remdesivir toxicity that accrues after five days.
Similar Outcomes of Five Days of Remdesivir Vs. 10 Days of Remdesivir Vs. Usual Care in Patients with Moderate COVID-19 Pneumonia. We have previously summarized several studies of remdesivir published in NEJM. A Research Brief posted on April 17, 2020, described a case series with 53 patients with severe COVID-19. The ACTT study reported in a Research Brief posted on April 30, 2020 (updated in a Research Brief on June 2, 2020), was a randomized trial of 1,063 patients with COVID-19 with lung involvement that found speedier recovery and a trend toward lower mortality. In contrast, a Chinese randomized trial with 237 patients with COVID-19 pneumonia and hypoxia found no improvement in mortality. We also summarized a flawed study (Research Brief from June 3, 2020) that found comparable outcomes of five days and 10 days of remdesivir in patients with severe COVID-19. Finally, a recent systematic review (Research Brief from August 28, 2020, based on a study in BMJ) found that remdesivir had no overall benefit on mortality, use of mechanical ventilation, duration of mechanical ventilation, viral clearance, or hospital length of stay but that it decreased symptom duration and was unlikely to cause adverse events. We now have another randomized trial from the same team that compared five days and 10 days in patients with severe COVID-19 that was not included in the aforementioned systematic review. The researchers randomized patients hospitalized with moderate COVID-19 pneumonia (not requiring mechanical ventilation, no ARDS) to receive, unblinded, 10 days of remdesivir (n = 197), five days of remdesivir (n = 199), or usual care (n = 200). This study used a 7-point scale (ranging from death to hospitalized with various measures to not hospitalized) and had significant differences in baseline characteristics of the patients. For example, the patients randomized to 10 days of remdesivir were slightly more likely to have diabetes (44% vs. 37% and 38%), and about 10% of patients randomized to either remdesivir arms also received hydroxychloroquine compared with nearly half of the patients receiving usual care.
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"...remdesivir was not associated with statistically significant clinical benefits."
No specific antiviral drug has been proven effective for treatment of patients with severe coronavirus disease 2019 (COVID-19). Remdesivir (GS-5734), a nucleoside analogue prodrug, has inhibitory effects on pathogenic animal and human coronaviruses, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in vitro, and inhibits Middle East respiratory syndrome coronavirus, SARS-CoV-1, and SARS-CoV-2 replication in animal models.
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Remdesivir showed modest success in a federally funded clinical trial, slowing the progression of the disease, but without significantly reducing fatality rates.
On Friday, the Food and Drug Administration granted emergency authorization for the use of remdesivir as a treatment of severely ill patients.
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First trial for potential Covid-19 drug shows it has no effect
WHO draft put online states remdesivir does not benefit severe coronavirus patients
In a “gold standard” trial of 237 patients, some of whom received remdesivir while others did not, the drug did not work. The trial was also stopped early because of side-effects.
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World's top intensive care body advises against use of remdesivir for sickest COVID-19 patients
The antiviral drug remdesivir should not be used as a routine treatment for COVID-19 patients in critical care wards, the head of one of the world's top bodies representing intensive care doctors said, in a blow to the drug developed by U.S. firm Gilead.
Remdesivir, also known as Veklury, and the steroid dexamethasone are the only drugs authorized to treat COVID-19 patients across the world.
But the largest study on remdesivir's efficacy, run by the World Health Organization (WHO), showed on Oct. 15 that it had little or no impact, contradicting previous trials.
In light of the new interim data from the WHO's Solidarity trial, "remdesivir is now classified as a drug you should not use routinely in COVID-19 patients," the president of the European Society of Intensive Care Medicine (ESICM), Jozef Kesecioglu, said in an interview with Reuters.
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