Use of Remedesivir To Adults

Indications

Remdesivir is a broad-spectrum antiviral agent that has previously demonstrated antiviral activity against filoviruses (Ebola viruses, Marburg virus), coronaviruses (SARS-CoV, MERS-Co-V, SARS-CoV-2), paramyxoviruses (parainfluenza type III virus, Nipah virus, Hendra virus, measles, and mumps virus), and Pnemoviridae (respiratory syncytial virus) . Remdesivir was initially developed against the Ebola virus based on its antiviral properties demonstrated in vitro and in vivo in animal models but failed to demonstrate efficacy in randomized clinical trials. Remdesivir was shown to exhibit antiviral activity against SARS-CoV-2 in vitro studies, and it was proposed as an investigational drug early during the pandemic. However, based on data from randomized clinical trials that demonstrated superior clinical efficacy of remdesivir to placebo, remdesivir is the first and only available therapeutic drug that has been approved by the US Food and Drug Administration (FDA) for clinical use in the management of patients with severe suspected or laboratory-confirmed COVID-19.

FDA approved indication or emergency use authorization (EUA) of Remdesivir (with clinical trial summaries)

• Adults and pediatric patients (over age 12 years and weighing at least 40 kgs or more) hospitalized patients with COVID-19
  • Results of a randomized, open-label trial of hospitalized patients admitted with moderate COVID-19 illness who were randomized to receive a 10-day course of remdesivir(n=197), a 5-day course of remdesivir(n=199), or standard of care(n=200) reported that patient is receiving the 10-day course of remdesivir did not have a statistically significant difference in clinical status compared to patients receiving standard of care. 
  • However, patients randomized to a 5-day course of remdesivir had a statistically significant difference in the clinical status compared to standard of care.
  • Final results of another double-blind, randomized placebo-controlled trial evaluating the efficacy of remdesivir in hospitalized patients with confirmed SARS-CoV-2 and COVID-19 pneumonia demonstrated that remdesivir was superior to placebo in shortening the time to clinical recovery. 
  • However, results from the WHO Solidarity Trial conducted at 405 hospitals spanning across 40 countries involving 11,330 inpatients with COVID-19 who were randomized to receive remdesivir (2750), hydroxychloroquine (954), lopinavir (1411), and interferon regimens(2063), and no trial drug(4088) reported that remdesivir, hydroxy chloroquine, lopinavir, and interferon regimens had little or no effect on overall mortality, initiation of mechanical ventilation, and length of hospital stay. 
  • Based on the encouraging data from three randomized, controlled clinical trials that purely evaluated the clinical efficacy of remdesivir in patients hospitalized with mild-to-severe COVID-19, the U.S. Food and Drug Administration(FDA) approved remdesivir for treatment in adults and pediatric patients (over age 12 years and weighing at least 40 kgs or more) hospitalized patients with COVID-19.
  • Currently, remdesivir is the first and only available therapeutic drug that has been approved by the US Food and Drug Administration (FDA) for clinical use in the management of patients with severe suspected or laboratory-confirmed COVID-19 infection, with severity being defined as SpO 2</= 94% on room air requiring supplemental oxygen, mechanical ventilation, and/or extracorporeal membrane oxygenation (ECMO).