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This page undergoes regular review and was last comprehensively reviewed on September 26, 2022. Some sections may reflect more recent updates.



Remdesivir (brand name Veklury) is an intravenous nucleotide prodrug of an adenosine analog that was initially developed during the 2013 Ebola epidemic (Weston, March 2020; Brown, September 2019) and is FDA-approved for the treatment of COVID-19. When converted to its active form (largely by plasma carboxylesterases; its further metabolism is largely mediated by hydrolases), remdesivir interferes with RNA polymerase and is thought to lead to premature termination of RNA transcription (Yang, September 2020). It is also able to evade viral exonuclease proofreading, which is an advantage, as the ability of the coronavirus to detect and remove any incompatible nucleotides during its replication and transcription can block the efficacy of drugs that work by altering coronavirus nucleotide sequence.  Remdesivir is expected to remain active against the Omicron variant of SARS-CoV-2 and all its lineages (BA.4, BA.5, etc.).

Inpatient Use


Remdesivir may be used in hospitalized adults and pediatric patients aged 28 days and older weighing at least 3 kilograms (~6.6 pounds) with positive results of direct SARS-CoV-2 viral testing, according to its prescribing information.


Dose for Adults and Children ≥12 years old and weighing ≥40 kg:

Remdesivir 200 mg IV on day 1, then remdesivir 100 mg IV once daily from days 2-5 (or until hospital discharge, whichever is first)

Dose for Children Aged ≥28 Days and Weighing 3 kg to <40 kg:

Remdesivir 5 mg/kg IV on day 1, then remdesivir 2.5 mg/kg IV once daily from days 2-5 (or until hospital discharge, whichever is first)

  • Remdesivir 5 mg/kg IV on day 1, then remdesivir 2.5 mg/kg IV once daily from days 2-5 or until hospital discharge.

Clinical Guidelines & Decision-Making

In patients on supplemental oxygen but not on mechanical ventilation or ECMO, the IDSA panel suggests treatment with five days of remdesivir rather than 10 days of remdesivir (conditional recommendation, low certainty of evidence).

In patients with COVID-19 admitted to the hospital without the need for supplemental oxygen and oxygen saturation >94% on room air, the IDSA panel suggests against the routine use of remdesivir (conditional recommendation, very low certainty of evidence).

Clinical Trials

Several large, randomized trials have been published on the use of remdesivir in hospitalized patients with COVID-19, many of which are summarized in this NIH table.

  • ACTT-1 showed a reduction in time to clinical improvement and, in subgroup analysis, a mortality benefit in patients requiring supplemental oxygen but not ventilation.
  • ACTT-1’s primary endpoint was time to clinical improvement — it was not powered for mortality.
  • Conversely, the WHO SOLIDARITY trial showed no mortality benefit with the use of remdesivir.
  • Notably, the trials had different primary endpoints, and thus varied in design and what they were powered to examine.
  • SOLIDARITY was powered for mortality but was not designed to examine subgroups by time to clinical improvement or based on clinical status other than ventilated versus non-ventilated.
  • A quarter of patients in ACTT-1 were ventilated upon enrollment, as opposed to 8% in SOLIDARITY. Approximately a quarter of patients in ACTT-1 received concomitant glucocorticoids, while nearly half did in SOLIDARITY. Time from symptom onset to randomization was examined in ACTT-1, but similar data was not available for SOLIDARITY. The majority of patients in ACTT-1 lived in North America, while the majority in SOLIDARITY lived in Asia, Africa or Latin America.

Inserm’s Phase 3 DisCoVeRy trial (conducted at 48 sites in Europe as an add-on to the WHO Solidarity trial) was stopped in January 2021 after a Data and Safety Monitoring Board review evaluated participants on remdesivir (200 mg IV on day 1 followed by 100 mg IV thereafter for 9 more days) and on standard of care and found no evidence of efficacy in clinical status or viral clearance at 15 or 29 days after initiation of remdesivir. There was also no mortality difference between the two study arms (8% in remdesivir and 9% in placebo died (Adler, September 2021). However, looking at the subset of patients who were not on mechanical ventilation or ECMO at study entry, remdesivir did significantly delay progression to mechanical ventilation or death, which is in line with the findings of the ACTT-1 trial. There were important differences between the study populations in ACTT-1 and DisCoVeRy, that might partially explain the discrepant findings. Fewer ACTT-1 participants were on oxygen at baseline than DisCoVeRy participants (87% vs. 99%) and fewer received steroids (23% vs. 40%, respectively). 

A large, pragmatic open-label clinical trial from Canada (CATCO) followed; it showed that there was no significant difference in in-hospital deaths between the two arms. Death occurred in 19% of patients in the remdesivir arm vs. 23% in the standard of care arm (relative risk 0.83; 95% CI, 0.67–1.03) However, there was a significant decrease in the need for mechanical ventilation in the remdesivir arm: 8% in remdesivir arm vs. 15% in SOC arm (relative risk 0.53; 95% CI, 0.38–0.75).

Real-World Evidence

There have been efforts to capture large-scale observational data on remdesivir outcomes. An observational analysis of a large real-world database (N= 28,855 remdesivir patients and 16,687 propensity-matched non-remdesivir patients) compared mortality between hospitalized COVID-19 patients who did and did not get remdesivir (Mozaffari, October 2021). During the study period (between August and November 2020), patients on remdesivir had a significantly lower risk of death at day 14 than patients not on remdesivir (for both those on low-flow and high-flow oxygen at baseline, aHR 0.76 [0.68-0.83]). A mortality difference was also seen on day 28 (aHR 0.89 [0.82-0.96]). These findings accord with the ACTT-1 trial and trends seen in the Solidarity trial.

Another retrospective observational study conducted at five hospitals in the Baltimore and Washington DC area (N=358 remdesivir; 1,957 controls) looked at whether remdesivir with or without corticosteroids hastened clinical improvement among hospitalized patients with confirmed COVID-19 (Garibaldi, March 2021).  This study used propensity-score matching to pair each remdesivir recipient with a patient who did not receive remdesivir, based on age, severity of illness, sex and other clinical parameters, and examined a primary outcome of rate of clinical improvement (hospital discharge or decrease of two points on a clinical severity scale). The study found that remdesivir recipients had a faster time to clinical improvement than controls (median [IQR] of 5 days [4-8] vs. 7 days [4-10], respectively). The mortality rate was 7.7% and 14% in the remdesivir and control groups, respectively (aHR non-significant at 0.70; 95% CI, 0.38-1.28). Furthermore, the study did not find an additive benefit in time to clinical improvement when corticosteroids were added to remdesivir. This study was followed by another, larger retrospective study by the same authors of 96,859 individuals hospitalized with COVID-19 (42,474 of whom received remdesivir), which showed a significantly greater likelihood of clinical improvement at 28 days among remdesivir recipients, particularly among those participants on no oxygen or low-flow oxygen (aHR 1.30 [95% CI, 1.22-1.38] and aHR 1.23 [95% CI, 1.19-1.27], respectively). The same study also found that remdesivir recipients on low-flow oxygen were significantly less likely to die than those who did not receive remdesivir (aHR 0.85 [95% CI, 0.77-0.92]).  In terms of antiviral effect, an independent add-on randomized controlled study (N=185) to the WHO Solidarity trial, NOR-Solidarity, found that remdesivir did not affect viral clearance of SARS-CoV-2 among hospitalized people with COVID-19 (Barratt-Due, September 2021). A meta-analysis of four randomized trials of remdesivir (7,333 total patients across studies) found uncertain impact of remdesivir on death or progression to mechanical ventilation, with an odds ratio for mortality with remdesivir of 0.9 (95% CI, 0.7-1.12) and for mechanical ventilation of 0.9 (95% CI, 0.76-1.03) as compared to placebo or usual care (Siemieniuk, July 2020). Subgroup analyses on patients with lesser degrees of illness were absent, which may have occluded a benefit in a certain subgroup (i.e., the subgroup shown to benefit in the ACTT-1 trial, those requiring low-flow supplemental oxygen).


Ambulatory/Outpatient Use


Remdesivir may be prescribed to non-hospitalized adults and pediatric patients aged 28 days and older weighing at least 3 kilograms (~6.6 pounds) who have mild-to-moderate COVID-19 symptoms, positive results of direct SARS-CoV-2 viral testing and are at high risk for progression to severe COVID-19, including hospitalization or death. Treatment for nonhospitalized patients should begin as soon as possible after diagnosis and must be initiated within 7 days of symptom onset.


Outpatient remdesivir therapy consists of a three-day course. Adult and pediatric patients aged ≥12 years and weighing ≥40 kg receive dosing of 200 mg IV on day 1 followed by 100 mg IV on days 2 and 3. For patients younger than 12 years, dosing is 5 mg/kg IV on day 1 and 2.5 mg/kg IV on days 2 and 3.

Dose for Adults and Children ≥12 years old and weighing ≥40 kg:

remdesivir 200 mg IV on day 1, then remdesivir 100 mg IV once daily from days 2-3

Dose for Children Aged ≥28 Days and Weighing 3 kg to <40 kg:

remdesivir 5 mg/kg IV on day 1, then remdesivir 2.5 mg/kg IV once daily from days 2 -3


Clinical Guidelines & Decision-Making 

Among ambulatory patients with mild-to-moderate COVID-19 at high risk for progression to severe disease, IDSA guidelines suggest remdesivir for 3 days, initiated within 7 days of symptom onset, rather than no remdesivir (conditional recommendation, low certainty of evidence).

In nonhospitalized patients at high risk for progression to severe disease, NIH guidelines also suggest starting remdesivir within 7 days of symptom onset and administered for a total of 3 days (the PINE-TREE study protocol – Gottlieb, January 2022).

Clinical Trials

A single Phase 3 randomized placebo-controlled trial called the PINE-TREE study examined the impact of 3 days of remdesivir (a 200 mg IV load followed by 100 mg IV infusions on the 2 subsequent days) on the endpoint of COVID-related hospitalization or death among high-risk outpatients. The study, which had to stop enrollment early due to enrollment feasibility concerns relating to scarce patients, found that 2/279 (0.7%) remdesivir recipients met the primary endpoint, as compared to 15/283 (5.3%) placebo recipients, for a significant 87% relative risk reduction (HR 0.13 [0.03-0.59]; p=0.008) and number needed to treat of 21 to prevent one hospitalization or death.


Although a full understanding of remdesivir’s safety profile remains incomplete, these are several notable considerations. 

Liver Testing

According to NIH guidelines: “Remdesivir can cause gastrointestinal symptoms (e.g., nausea), elevated transaminase levels, an increase in prothrombin time without a change in the international normalized ratio, and hypersensitivity reactions.                                                         

“Liver function tests and prothrombin time tests should be performed for all patients before they receive remdesivir, and these tests should be repeated during treatment as clinically indicated. Remdesivir may need to be discontinued if a patient’s alanine transaminase (ALT) level increases to >10 times the upper limit of normal, and it should be discontinued if an increase in ALT level and signs or symptoms of liver inflammation are observed.” This is concordant with FDA label guidance (see package insert sections 5.2 and 2.1).                         


There have been reports of bradycardia in patients receiving remdesivir, and an analysis of WHO safety reports found an increased likelihood of bradycardia among remdesivir recipients, compared to other agents, with a reporting OR of 1.65 (95% CI, 1.23-2.22) (Touafchia, February 2021; Barkas, February 2021; Gubitosa, November 2020).                                

Patients with Renal Insufficiency (eGFR <30 mL/min)

In the FDA prescribing information, remdesivir is not recommended in people with eGFR <30 mL/min due to a concern about accumulation of its renally cleared excipient, sulfobutylether beta-cyclodextrin sodium (SBECD) (see package insert).

IDSA guidelines state “additional research into safety of remdesivir in patients with reduced renal function is needed to ascertain whether this concern is substantiated.” NIH guidelines state the amount of SBECD in a course of remdesivir “is within the safety threshold (250 mg/ kg/day of SBECD) for patients with normal renal function, but accumulation of SBECD in patients with renal impairment may result in liver and renal toxicities. Clinicians may consider preferentially using the lyophilized powder formulation (which contains less SBECD — 3 g per 100 mg dose, as compared to 6 g per 100 mg dose in the liquid formulation) in patients with renal impairment.”

Concerns can be partially allayed by accumulating safety data on the use of remdesivir in patients with eGFR <30 mL/min and the favorable safety record of IV voriconazole, which contains the same SBECD excipient, and is used routinely in people with eGFR < 30 mL/min (Seethapathy, June 2022). Clinicians should monitor kidney function in all patients on remdesivir, particularly those with preexisting renal impairment and those receiving other nephrotoxins.   

Drug-Drug Interactions

Remdesivir has not been studied in clinical drug-drug interaction studies. In vitro, it is a substrate for CYP3A4 and OATP1B1 as well as P-glycoprotein transporters and an inhibitor of CYP3A4 and OATP1B1; the clinical relevance of this has not been established (see package insert).


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