Remdesivir

(Veklury®)

Remdesivir

Drug updated on 10/28/2024

Dosage FormInjection (intravenous; 100 mg lyophilized powder, 100 mg/20 mL [5 mg/mL] in a single-dose vial)
Drug ClassSARS-CoV-2 nucleotide analog RNA polymerase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to less than 18 years of age weighing at least 1.5 kg) who are hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

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Summary
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  • This summary is based on the review of 97 systematic review(s)/meta-analysis(es). [1-97]
  • Remdesivir demonstrated a significant benefit in clinical progression and recovery for hospitalized patients with COVID-19, showing improved clinical progression (RR 1.06, 95% 0.48,0.68 (CI (confidence interval)) 1.02-1.11) and decreased clinical deterioration (RR 0.75, 95% CI 0.61-0.89), with a recovery rate 1.29 times higher than control (RR 1.29, 95% CI 1.03-1.60) and reducing time to clinical improvement by approximately 2.99 days (95% CI 2.71-3.28).
  • The effect of remdesivir on mortality was mixed; it showed a potential reduction in mortality overall (RR 0.90, 95% CI 0.83-0.98), particularly in non-critically ill patients requiring low-flow oxygen (RR 0.74, 95% CI 0.49-1.11), while having no significant benefit for critically ill patients requiring mechanical ventilation (RR 0.96, 95% CI 0.87-1.04).
  • Remdesivir was associated with a reduced need for mechanical ventilation (RR 0.68, 95% CI 0.51-0.90) and invasive mechanical ventilation or OR: 0.59, 95% CI: 0.46-0.76 (ECMO (extracorporeal membrane oxygenation)) (OR 0.59, 95% CI 0.46-0.76), along with benefits in reducing ICU (intensive care unit) admissions (OR 2.39, 95% CI 1.24-4.57), especially for outpatients with mild to moderate disease (RR 0.13, 95% CI 0.03-0.59) and for all-cause hospitalization (RR 0.28, 95% CI 0.10-0.75).
  • Remdesivir did not result in a significant increase in adverse events compared to placebo (RR 0.98, 95% CI 0.91-1.06), while there was a noted reduction in serious adverse events (RR 0.77, 95% CI 0.57-1.03), indicating a favorable safety profile.
  • The use of remdesivir was associated with a higher risk of bradycardia (OR 2.556, 95% CI 2.049-3.188); however, this did not correlate with an increase in mortality rates. Additionally, remdesivir did not significantly affect liver or kidney function, with risk ratios of RR 0.87 (95% CI 0.68-1.11) for liver damage and RR 0.88 (95% CI 0.70-1.10) for kidney damage.
  • In patients with renal impairment, remdesivir showed no significant increase in adverse effects, suggesting it may be safer for this population than previously thought. Limited safety data for pregnant women and pediatric patients indicate potential benefits, though further investigation is required to confirm safety and efficacy in these groups.
  • Remdesivir demonstrated a better safety profile compared to hydroxychloroquine, which increased the risk of cardiac toxicity and cognitive dysfunction, and had fewer gastrointestinal adverse effects compared to lopinavir/ritonavir.
  • Most studies on remdesivir focused on hospitalized adults with varying severity of COVID-19, showing pronounced benefits for patients requiring supplemental oxygen but not those needing mechanical ventilation. Outpatients with mild to moderate disease demonstrated significant reductions in hospitalization rates (RR 0.13, 95% CI 0.03-0.59) and all-cause hospitalization (RR 0.28, 95% CI 0.10-0.75).
  • Patients with chronic kidney disease and obesity were identified as high-risk subgroups for experiencing remdesivir-induced bradycardia (OR 2.556, 95% CI 2.049-3.188). Limited data suggest potential benefits of remdesivir for pregnant women, although further investigation into safety and efficacy is necessary, and data on pediatric patients are currently insufficient.

Product Monograph / Prescribing Information

Document TitleYearSource
Veklury (remdesivir) Prescribing Information.2024Gilead Sciences, Inc., Foster City, CA

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Remdesivir in solid organ transplant recipients with COVID-19: a systematic review and meta-analysis2024Clinical Transplantation and Research
Among Patients with COVID-19, should Remdesivir be Used for Treatment? A Systematic Review and Meta-analysis2024Acta Medica Philippina
Update on efficacy of the approved remdesivir regimen for treatment of COVID-19: a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials2024Current Medical Research and Opinion
Safety and Efficacy of Convalescent Plasma Combined with Other Pharmaceutical Agents for Treatment of COVID-19 in Hospitalized Patients: A Systematic Review and Meta-Analysis2024Diseases
The effects of remdesivir on mortality and the requirement for mechanical ventilation in patients with COVID-19: a systematic review stratified by disease severity2024The Korean Journal of Internal Medicine
Comparative efficacy and safety of anti-infective drugs for patients with mild to severe COVID-19: A systematic review and network meta-analysis of randomized controlled trials2023Ethiopian Medical Journal
A systematic review and meta-analysis of randomized controlled trials with trial sequence analysis of remdesivir for COVID-19 treatment2023International Journal of Critical Illness and Injury Science
Remdesivir-Induced Bradycardia and Mortality in SARS-CoV-2 Infection, Potential Risk Factors Assessment: A Systematic Review and Meta-Analysis2023Journal of Clinical Medicine
Outpatient randomized controlled trials to reduce COVID-19 hospitalization: Systematic review and meta-analysis2023Journal of Medical Virology
The impact of vaccination and outpatient treatment on the economic burden of Covid-19 in the United States omicron era: a systematic literature review2023Journal of Medical Economics
Efficacy and safety of therapies for COVID-19 in pregnancy: a systematic review and meta-analysis2023BMC Infectious Diseases
Assessment of the available therapeutic approaches for severe COVID-19: a meta-analysis of randomized controlled trials2023Scientific Reports
The efficacy and safety of remdesivir alone and in combination with other drugs for the treatment of COVID-19: a systematic review and meta-analysis2023BMC Infectious Diseases
An Updated Systematic Review on Remdesivir's Safety and Efficacy in Patients Afflicted With COVID-192023Cureus
Remdesivir Treatment Lacks the Effect on Mortality Reduction in Hospitalized Adult COVID-19 Patients Who Required High-Flow Supplemental Oxygen or Invasive Mechanical Ventilation2023Medicina
Acute kidney injury in COVID-19 patients receiving remdesivir: A systematic review and meta-analysis of randomized clinical trials2023Clinics
Effects of remdesivir in patients hospitalised with COVID-19: a systematic review and individual patient data meta-analysis of randomised controlled trials2023The Lancet. Respiratory medicine
Remdesivir for the treatment of COVID-192023The Cochrane Database of Systematic Reviews
Pregnancy and COVID-19: high or low risk of vertical transmission2023Clinical and Experimental Medicine
Outpatient regimens to reduce COVID-19 hospitalisations: a systematic review and meta-analysis of randomized controlled trials2023medRxiv
Antiviral Treatment in COVID-19 Outpatients: A Systematic Review of Randomized Controlled Trials2022Acta Medica Indonesiana
Comparative efficacy and safety of pharmacological interventions for severe COVID-19 patients: An updated network meta-analysis of 48 randomized controlled trials2022Medicine
The Clinical Efficacy and Safety of Anti-Viral Agents for Non-Hospitalized Patients with COVID-19: A Systematic Review and Network Meta-Analysis of Randomized Controlled Trials2022Viruses
Remdesivir Administration in COVID-19 Patients With Renal Impairment: A Systematic Review2022American Journal of Therapeutics
Antiviral drug treatment for nonsevere COVID-19: a systematic review and network meta-analysis2022CMAJ
Remdesivir for the treatment of patients hospitalized with COVID-19 receiving supplemental oxygen: a targeted literature review and meta-analysis2022Scientific Reports
Efficacy of COVID-19 treatments among geriatric patients: a systematic review2022Therapeutic Advances in Infectious Disease
Remdesivir for the treatment of COVID-19: a systematic review and meta-analysis2022Clinical Microbiology and Infection
Remdesivir and three other drugs for hospitalised patients with COVID-19: final results of the WHO Solidarity randomised trial and updated meta-analyses2022Lancet
Efficacy of pharmacological interventions in COVID-19: A network meta-analysis2022British Journal of Clinical Pharmacology
Efficacy of early use of remdesivir: a systematic review of subgroup analysis2022Revista Espanola de Quimioterapia
Adverse effects of remdesivir, hydroxychloroquine and lopinavir/ritonavir when used for COVID-19: systematic review and meta-analysis of randomised trials2022BMJ Open
Major Update 2: Remdesivir for Adults With COVID-19: A Living Systematic Review and Meta-analysis for the American College of Physicians Practice Points2022Annals of Internal Medicine
Potentially effective drugs for the treatment of COVID-19 or MIS-C in children: a systematic review2022European Journal of Pediatrics
Use of remdesivir in patients with COVID-19: a systematic review and meta-analysis2022Jornal Brasileiro de Pneumologia
Remdesivir for pregnancy: A systematic review of antiviral therapy for COVID-192022Heliyon
Efficacy of antiviral therapies for COVID-19: a systematic review of randomized controlled trials2022BMC Infectious Diseases
Efficacy and safety of remdesivir in hospitalised COVID-19 patients: a systematic review and meta-analysis2022Infection
Antiviral drugs for coronavirus disease 2019 (COVID-19): a systematic review with network meta-analysis2022Expert Review of Anti-Infective Therapy
The use of remdesivir for the management of patients with moderate-to-severe COVID-19: a systematic review2022Expert Review of Anti-Infective Therapy
The impact of therapeutics on mortality in hospitalised patients with COVID-19: systematic review and meta-analyses informing the European Respiratory Society living guideline2021European respiratory review
Effectiveness of Remdesivir, Lopinavir/Ritonavir, and Favipiravir for COVID-19 Treatment: A Systematic Review2021International Journal of General Medicine
COVID-19 treatment in children: A systematic review and meta-analysis2021Journal of Family Medicine and Primary Care
Efficacy of COVID-19 Treatments: A Bayesian Network Meta-Analysis of Randomized Controlled Trials2021Frontiers in Public Health
Drug-Induced Liver Injury in COVID-19 Patients: A Systematic Review2021Frontiers in Medicine
The safety, tolerability and mortality reduction efficacy of remdesivir; based on randomized clinical trials, observational and case studies reported safety outcomes: an updated systematic review and meta-analysis2021Therapeutic Advances in Drug Safety
Antiviral Therapeutic Approaches for SARS-CoV-2 Infection: A Systematic Review2021Pharmaceuticals
Remdesivir for the treatment of COVID-192021The Cochrane Database of Systematic Reviews
Clinical efficacy of antiviral agents against coronavirus disease 2019: A systematic review of randomized controlled trials2021Journal of Microbiology, Immunology, and Infection
Efficacy and safety of remdesivir in COVID-19 caused by SARS-CoV-2: a systematic review and meta-analysis2021BMJ Open
Safety and Efficacy of Remdesivir for the Treatment of COVID-19: A Systematic Review and Meta-Analysis2021Journal of Pharmacy & Pharmaceutical Sciences
Comparative Effectiveness of Pharmacological Interventions for Covid-19: A Systematic Review and Network Meta-Analysis2021Frontiers in Pharmacology
Remdesivir for coronavirus disease 2019 (COVID-19): a systematic review with meta-analysis and trial sequential analysis of randomized controlled trials2021Infectious Diseases
Third force in the treatment of COVID-19: A systematic review and meta-analysis2021Annals of Medicine and Surgery
Mortality in mechanically ventilated patients with COVID-19: a systematic review2021Expert Review of Medical Devices
Evaluation of the Current Therapeutic Approaches for COVID-19: A Systematic Review and a Meta-analysis2021Frontiers in Pharmacology
Clinical effectiveness of drugs in hospitalized patients with COVID-19: a systematic review and meta-analysis2021Therapeutic Advances in Respiratory Sisease
Clinical efficacy and safety of remdesivir in patients with COVID-19: a systematic review and network meta-analysis of randomized controlled trials2021The Journal of Antimicrobial Chemotherapy
Current evidence for COVID-19 therapies: a systematic literature review2021European Respiratory Review
Pharmacological interventions for COVID-19: a systematic review of observational studies and clinical trials2021Expert Review of Anti-Infective Therapy
Interventions for treatment of COVID-19: Second edition of a living systematic review with meta-analyses and trial sequential analyses (The LIVING Project)2021PloS One
An updated systematic review and network meta-analysis of 25 randomized trials assessing the efficacy and safety of treatments in COVID-19 disease2021Journal of Public Health Research
Immunomodulatory therapies for SARS-CoV-2 infection: a systematic literature review to inform EULAR points to consider2021Annals of the Rheumatic Diseases
Major Update: Remdesivir for Adults With COVID-19 : A Living Systematic Review and Meta-analysis for the American College of Physicians Practice Points2021Annals of Internal Medicine
Remdesivir for treatment of COVID-19; an updated systematic review and meta-analysis2021European Journal of Pharmacology
Systematic review and subgroup analysis of the incidence of acute kidney injury (AKI) in patients with COVID-192021BMC Nephrology
Remdesivir therapy in patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials2021Annals of Medicine and Surgery
A complementary critical appraisal on systematic reviews regarding the most efficient therapeutic strategies for the current COVID-19 (SARS-CoV-2) pandemic2021Journal of Medical Virology
Remdesivir for the treatment of COVID-19: A systematic review and meta-analysis of randomized controlled trials2021Contemporary Clinical Trials
Treatment of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), and coronavirus disease 2019 (COVID-19): a systematic review of in vitro, in vivo, and clinical trials2021Theranostics
The use of convalescent plasma for pediatric patients with SARS-CoV-2: A systematic literature review2021Transfusion and Apheresis Science
Remdesivir for the treatment of coronavirus COVID-19: A meta-analysis of randomised controlled trials2021Journal of Global Antimicrobial Resistance
Remdesivir: A potential game-changer or just a myth? A systematic review and meta-analysis2021Life Sciences
Effect of remdesivir on mortality in patients with COVID-19: A meta-analysis of randomized control trials2021Journal of Medical Virology
Remdesivir for Adults With COVID-19 : A Living Systematic Review for American College of Physicians Practice Points2021Annals of Internal Medicine
Evaluation of current medical approaches for COVID-19: a systematic review and meta-analysis2021BMJ Supportive & Palliative Care
The effect of antivirals on COVID-19: a systematic review2021Expert Review of Anti-Infective Therapy
Remdesivir and its antiviral activity against COVID-19: A systematic review2021Clinical Epidemiology and Global Health
Effectiveness of remdesivir for the treatment of hospitalized COVID-19 persons: A network meta-analysis2021Journal of Medical Virology
Efficacy and safety of antivirals for Covid-19: A systematic review and meta-analysis2020The National Medical Journal of India
Molecular Mechanism of Action of Repurposed Drugs and Traditional Chinese Medicine Used for the Treatment of Patients Infected With COVID-19: A Systematic Scoping Review2020Frontiers in Pharmacology
The efficacy of remdesivir in coronavirus disease 2019 (COVID-19): a systematic review2020Iranian Journal of Microbiology
Mortality Benefit of Remdesivir in COVID-19: A Systematic Review and Meta-Analysis2020Frontiers in Medicine
Systematic Review on the Therapeutic Options for COVID-19: Clinical Evidence of Drug Efficacy and Implications2020Infection and Drug Resistance
Evaluating the Efficacy and Safety of the Existing Repurposed Pharmacological Agents for Treating COVID-19: A Meta-analysis and Systematic Review of Clinical Trials2020Indian Journal of Critical Care Medicine
Comparative efficacy and safety of pharmacological interventions for the treatment of COVID-19: A systematic review and network meta-analysis2020PLoS Medicine
Remdesivir for the treatment of COVID-19: a living systematic review2020Medwave
Efficacy and harms of remdesivir for the treatment of COVID-19: A systematic review and meta-analysis2020PLoS One
Systematic review on current antiviral therapy in COVID-19 pandemic2020The Medical Journal of Malaysia
Immune Therapy, or Antiviral Therapy, or Both for COVID-19: A Systematic Review2020Drugs
Effect of remdesivir on patients with COVID-19: A network meta-analysis of randomized control trials2020Virus Research
Efficacy of various treatment modalities for nCOV-2019: A systematic review and meta-analysis2020European Journal of Clinical Investigation
Perspectives on the Early Quality of Evidence Guiding the Therapeutic Management of SARS-CoV-2: A Systematic Literature Review2020Advances in Therapy
Remdesivir for the Treatment of COVID-19: A Systematic Review of the Literature2020The Western Journal of Emergency Medicine
Pharmacokinetics/Pharmacodynamics of Antiviral Agents Used to Treat SARS-CoV-2 and Their Potential Interaction with Drugs and Other Supportive Measures: A Comprehensive Review by the PK/PD of Anti-Infectives Study Group of the European Society of Antimicrobial Agents2020Clinical Pharmacokinetics
An overview of the safety, clinical application and antiviral research of the COVID-19 therapeutics2020Journal of Infection and Public Health
Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment2020Drug Safety

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