Remdesivir is an intravenous nucleotide prodrug of an adenosine analog. Remdesivir binds to the viral RNA-dependent RNA polymerase and inhibits viral replication through premature termination of RNA transcription. It has demonstrated in vitro activity against SARS-CoV-2.1 In a rhesus macaque model of SARS-CoV-2 infection, remdesivir treatment was initiated soon after inoculation; the remdesivir-treated animals had lower virus levels in the lungs and less lung damage than the control animals.2
Remdesivir is approved by the Food and Drug Administration (FDA) for the treatment of COVID-19 in hospitalized adult and pediatric patients (aged ≥12 years and weighing ≥40 kg). It is also available through an FDA Emergency Use Authorization (EUA) for the treatment of COVID-19 in hospitalized pediatric patients weighing 3.5 kg to <40 kg or aged <12 years and weighing ≥3.5 kg. Remdesivir should be administered in a hospital or a health care setting that can provide a similar level of care to an inpatient hospital.
Remdesivir has been studied in several clinical trials for the treatment of COVID-19. The recommendations from the COVID-19 Treatment Guidelines Panel (the Panel) are based on the results of these studies.
Remdesivir is an investigational drug being studied to treat coronavirus infection, also known as COVID-19. It has not been approved by the FDA for general use. However, the FDA is now allowing remdesivir to be used in human studies and for emergency use in certain hospitalized patients. More information should be provided by the doctor from either the Informed Consent form for a study or the FDA Fact Sheet for Patients and Parents/Caregivers for emergency use.There is limited information known about the safety and effectiveness of using remdesivir to treat COVID-19. Some study results show that remdesivir may help some patients get better sooner. The information in this document reflects preliminary and emerging data, which is evolving and subject to reassessment. Users should be aware of these considerations in their review of investigational drug data, and it is always the responsibility of treating practitioners to exercise independent judgment in making care decisions.
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