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Table 2a. Remdesivir: Selected Clinical Data

Last Updated: February 24, 2022

The clinical trials described in this table do not represent all the trials that the Panel reviewed while developing the recommendations for RDV. The studies summarized below are the randomized controlled trials that have had the greatest impact on the Panel’s recommendations. Studies of hospitalized patients are listed first, followed by studies of nonhospitalized patients.

Table 2a. Remdesivir: Selected Clinical Data
Methods Results Limitations and Interpretation
ACTT-1: Multinational, Placebo-Controlled, Double-Blind RCT of Remdesivir in Hospitalized Patients With COVID-191
Key Inclusion Criteria:
  • Laboratory-confirmed SARS-CoV-2 infection
  • ≥1 of the following criteria:
    • Pulmonary infiltrates
    • SpO2 ≤94% on room air
    • Need for supplemental oxygen, high-flow oxygen, NIV, MV, or ECMO

Key Exclusion Criteria:

  • ALT or AST >5 times ULN
  • eGFR <30 mL/min
  • Pregnancy or breastfeeding

Interventions:

  • RDV 200 mg IV on Day 1, then RDV 100 mg daily for up to 9 more days (n = 541)
  • Placebo for up to 10 days (n = 521)

Primary Endpoint:

  • Time to clinical recovery

Key Secondary Endpoints

  • Clinical status at Day 15, as measured by an OS
  • Mortality by Day 29
  • Occurrence of SAEs

Participant Characteristics:

  • Mean age 58.9 years
  • 53.3% White, 21.3% Black, 12.7% Asian, 23.5% Hispanic/Latinx
  • Coexisting conditions: 26.2% with 1; 55.2% with ≥2
  • 13.0% not on oxygen; 41.0% on supplemental oxygen; 18.2% on high-flow oxygen or NIV; 26.8% on MV or ECMO
  • Median time from symptom onset to randomization: 9 days (IQR 6–12 days)
  • Received corticosteroids during study: 21.6% in RDV arm; 24.4% in placebo arm

Primary Outcomes:

  • Time to clinical recovery: 10 days in RDV arm vs. 15 days in placebo arm (rate ratio for recovery 1.29; 95% CI, 1.12–1.49; P < 0.001)
  • Benefit of RDV greatest in patients randomized during first 10 days after symptom onset and those who required supplemental oxygenation at enrollment
  • No difference in time to recovery for patients on high-flow oxygen, NIV, MV, or ECMO at enrollment

Secondary Outcomes:

  • Clinical status at Day 15: improvement more likely in RDV arm (OR 1.5; 95% CI, 1.2–1.9; P < 0.001)
  • Mortality by Day 29: no difference between arms
  • Proportion of patients with SAEs: similar between arms (25% vs. 32%)
Key Limitations:
  • Wide range of disease severity among patients; study not powered to detect differences within subgroups
  • Powered to detect differences in clinical improvement, not mortality
  • No data on longer-term morbidity

Interpretation:

  • In patients with severe COVID-19, RDV reduced time to clinical recovery.
  • The benefit was most apparent in hospitalized patients who were receiving supplemental oxygen.
  • There was no observed benefit in those on high-flow oxygen, NIV, MV, or ECMO, but study was not powered to detect differences within subgroups.
DisCoVeRy: Open-Label, Adaptive RCT of Remdesivir in Hospitalized Patients With Moderate or Severe COVID-19 in Europe2
Key Inclusion Criteria:
  • Laboratory-confirmed SARS-CoV-2 infection
  • Illness of any duration
  • SpO2 ≤94% on room air or use of supplemental oxygen, high-flow oxygen devices, NIV, or MV

Key Exclusion Criteria:

  • ALT or AST >5 times ULN
  • Severe chronic kidney disease

Interventions:

  • RDV 200 mg IV on Day 1, then RDV 100 mg IV once daily for up to 9 days (n = 429)
  • SOC (n = 428)

Primary Endpoint:

  • Clinical status at Day 15, as measured by an OS

Key Secondary Endpoint:

  • Mortality at Day 29
  • Occurrence of SAEs

Participant Characteristics:

  • Median age 64 years; 70% men; 69% White
  • 74% with ≥1 coexisting condition
  • 40% received corticosteroids during study
  • Median days from symptom onset to randomization: 9 days in both arms
  • 61% with moderate disease; 39% with severe disease

Primary Outcomes:

  • Clinical status at Day 15: no difference between arms (OR 0.98; 95% CI, 0.77–1.25; P = 0.85)
  • A prespecified subgroup analysis based on duration of symptoms found no significant difference in clinical status between arms.

Secondary Outcomes:

  • Mortality: no difference between arms (8% in RDV arm vs. 9% in SOC arm)
  • Proportion of patients with SAEs: no difference between arms (33% in RDV arm vs. 31% in SOC arm; P = 0.48)
Key Limitations:
  • Open-label study
  • 440 participants in this study also enrolled in the WHO Solidarity trial.

Interpretation:

  • There was no clinical benefit of RDV in hospitalized patients who were symptomatic for >7 days and who required supplemental oxygen.
WHO Solidarity Trial: Multinational, Open-Label, Adaptive RCT of Repurposed Drugs in Hospitalized Patients With COVID-193
Key Inclusion Criteria:
  • Aged ≥18 years
  • Not known to have received any study drug
  • Not expected to be transferred elsewhere within 72 hours

Interventions:

  • RDV 200 mg IV on Day 0, then RDV 100 mg daily on Days 1–9 (n = 2,743)
  • Local SOC (n = 2,708)

Primary Endpoint:

  • In-hospital mortality

Key Secondary Endpoint:

  • Initiation of MV

Participant Characteristics:

  • 47% aged 50–69 years; 18% aged ≥70 years
  • At entry: 67% on supplemental oxygen; 9% on MV
  • Rates of comorbidities similar between arms
  • 48% in both arms received corticosteroids during study

Primary Outcome:

  • In-hospital mortality: 11.0% in RDV arm vs. 11.2% in SOC arm (rate ratio 0.95; 95% CI, 0.81–1.11)

Secondary Outcome:

  • Initiation of MV: 10.8% in RDV arm vs. 10.5% in SOC arm
Key Limitations:
  • Open-label design limits ability to assess time to recovery, as RDV may have been continued even if patient improved.
  • No data on time from symptom onset to enrollment
  • No assessment of outcomes post hospital discharge

Interpretation:

  • RDV did not decrease in-hospital mortality or the need for MV compared to SOC.
GS-US-540-5774 Study: Multinational, Open-Label RCT of 10 Days or 5 Days of Remdesivir Compared With Standard of Care in Hospitalized Patients With Moderate COVID-194
Key Inclusion Criteria:
  • Laboratory-confirmed SARS-CoV-2 infection
  • Pulmonary infiltrates
  • SpO2 >94% on room air
Key Exclusion Criteria:
  • ALT or AST >5 times ULN
  • CrCl <50 mL/min

Interventions:

  • RDV 200 mg IV on Day 1, then RDV 100 mg daily for 9 days (n = 193)
  • RDV 200 mg IV on Day 1, then RDV 100 mg daily for 4 days (n = 191)
  • Local SOC (n = 200)

Primary Endpoint:

  • Clinical status at Day 11, as measured by an OS

Participant Characteristics:

  • Demographic and baseline disease characteristics similar across arms
  • Ranges for participant characteristics across the 3 arms:
    • Median age 56–58 years
    • Men: 60% to 63%
    • 81% to 87% required no supplemental oxygen; 12% to 18% required low-flow oxygen; 1% required high-flow oxygen or NIV
  • Concomitant medication use in the 10-day RDV, 5-day RDV, and SOC arms:
    • Steroids: 15%, 17%, 19%
    • Tocilizumab: 1%, 1%, 5%
    • HCQ/CQ: 11%, 8%, 45%
    • LPV/RTV: 6%, 5%, 22%
    • AZM: 21%, 18%, 31%
  • Median length of therapy: 6 days in 10-day RDV arm; 5 days in 5-day RDV arm

Primary Outcomes:

  • Clinical status at Day 11:
  • Significantly better in 5-day RDV arm than in SOC arm (OR 1.65; 95% CI, 1.09–2.48; P = 0.02)
  • No difference in clinical status at Day 11 between 10-day RDV arm and SOC arm (P = 0.18)
Key Limitations:
  • Open-label design may have affected decisions on concomitant medications (e.g., more patients in the SOC arm received AZM, HCQ or CQ, and LPV/RTV) and time of hospital discharge.
  • No data on time to return to activity for discharged patients

Interpretation:

  • Hospitalized patients with moderate COVID-19 who received 5 days of RDV had better clinical status at Day 11 than those who received SOC.
  • There was no difference in the clinical status at Day 11 between patients who received 10 days of RDV and those who received SOC.
GS-US-540-5773 Study: Multinational, Open-Label RCT of 10 Days or 5 Days of Remdesivir Compared with Standard of Care in Hospitalized Patients With Moderate COVID-195
Key Inclusion Criteria:
  • Laboratory-confirmed SARS-CoV-2 infection
  • Pulmonary infiltrates and SpO2 ≤94% on room air or receipt of supplemental oxygen
Key Exclusion Criteria:
  • Need for MV or ECMO
  • Multiorgan failure
  • ALT or AST >5 times ULN
  • Estimated CrCl <50 mL/min

Interventions:

  • RDV 200 mg IV on Day 1, then RDV 100 mg daily for 4 days (n = 200)
  • RDV 200 mg IV on Day 1, then RDV 100 mg daily for 9 days (n = 197)

Primary Endpoint:

  • Clinical status at Day 14, as measured by an OS

Key Secondary Endpoint:

  • Time to clinical improvement
  • Time to recovery

Participant Characteristics:

  • Median age 61 years in 5-day arm; 62 years in 10-day arm
  • 60% men in 5-day arm; 68% men in 10-day arm
  • Oxygen requirements at baseline for the 5-day and 10-day arms:
    • None: 17%, 11%
    • Low-flow supplemental oxygen: 56%, 54%
    • High-flow oxygen or NIV: 24%, 30%
    • MV or ECMO: 2%, 5%
  • Baseline clinical status: worse in 10-day arm than in 5-day arm (P = 0.02)

Primary Outcome:

  • Day 14 distribution in clinical status after adjusting for baseline clinical status: similar between arms (P = 0.14)

Secondary Outcomes:

  • Time to clinical improvement: similar between arms (10 days in 5-day arm vs. 11 days in 10-day arm)
  • Time to recovery: Median hospitalization duration for patients discharged on or before Day 14: similar between arms (7 days in 5-day arm vs. 8 days in 10-day arm)
Key Limitations:
  • Open-label trial
  • Baseline imbalances in clinical status of patients in 5-day and 10-day arms

Interpretation:

  • In hospitalized patients with severe COVID-19 who were not receiving MV or ECMO, using RDV for 5 or 10 days had similar clinical benefits.
PINETREE: Double-Blind, Placebo-Controlled RCT of Remdesivir for 3 Days in Nonhospitalized Patients With COVID-19 at High Risk for Disease Progression6
Key Inclusion Criteria:
  • Laboratory-confirmed SARS-CoV-2 infection ≤4 days from screening
  • Aged ≥12 years
  • ≥1 risk factor for disease progression
  • Symptom onset ≤7 days from randomization
  • ≥1 ongoing COVID-19 symptom
Key Exclusion Criteria:
  • COVID-19 vaccination
  • Supplemental oxygen
  • Previous hospitalization or treatment for COVID-19

Interventions:

  • RDV 200 mg IV on Day 1, then RDV 100 mg daily on Days 2 and 3 (n = 279)
  • Placebo (n = 283)

Primary Endpoints:

  • COVID-19-related hospitalizations or death from any cause by Day 28
  • Any AE

Key Secondary Endpoint:

  • COVID-19-related, medically attended visit or death from any cause by Day 28

Participant Characteristics:

  • Mean age 50 years; 30.2% aged ≥60 years; 52.1% men
  • 80.4% White, 7.5% Black, 41.8% Hispanic/Latinx
  • 61.6% with DM; 55.2% with obesity; 47.4% with HTN
  • Median duration of symptoms before first infusion: 5 days (IQR 3–6 days)
  • Median time from RT-PCR confirmation: 2 days (IQR 1–4 days)

Primary Outcomes:

  • COVID-19-related hospitalization or death from any cause by Day 28: 2 (0.7%) in RDV arm vs. 15 (5.3%) in placebo arm (HR 0.13; 95% CI, 0.03–0.59; P = 0.008)
  • AEs: 42.3% in RDV arm vs. 46.3% in placebo arm

Secondary Outcome:

  • COVID-19-related medically attended visit or death from any cause by Day 28: 4 (1.6%) in RDV arm vs. 2 (8.3%) in placebo arm (HR 0.19; 95% CI, 0.07–0.56)
Key Limitations:
  • Study halted early due to administrative issues.
  • Vaccinated individuals were excluded.

Interpretation:

  • Three consecutive days of IV RDV resulted in an 87% relative reduction in the risk of hospitalization or death when compared to placebo.

References

  1. Beigel JH, Tomashek KM, Dodd LE, et al. Remdesivir for the treatment of COVID-19—final report. N Engl J Med. 2020;383(19):1813-1826. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32445440.
  2. Ader F, Bouscambert-Duchamp M, Hites M, et al. Remdesivir plus standard of care versus standard of care alone for the treatment of patients admitted to hospital with COVID-19 (DisCoVeRy): a Phase 3, randomised, controlled, open-label trial. Lancet Infect Dis. 2022;22(2):209-221. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34534511.
  3. WHO Solidarity Trial Consortium, Pan H, Peto R, et al. Repurposed antiviral drugs for COVID-19—interim WHO Solidarity Trial results. N Engl J Med. 2021;384(6):497-511. Available at: https://www.ncbi.nlm.nih.gov/pubmed/33264556.
  4. Spinner CD, Gottlieb RL, Criner GJ, et al. Effect of remdesivir vs standard care on clinical status at 11 days in patients with moderate COVID-19: a randomized clinical trial. JAMA. 2020;324(11):1048-1057. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32821939.
  5. Goldman JD, Lye DCB, Hui DS, et al. Remdesivir for 5 or 10 days in patients with severe COVID-19. N Engl J Med. 2020;383(19):1827-1837. Available at: https://www.ncbi.nlm.nih.gov/pubmed/32459919.
  6. Gottlieb RL, Vaca CE, Paredes R, et al. Early remdesivir to prevent progression to severe COVID-19 in outpatients. N Engl J Med. 2022;386(4):305-315. Available at: https://www.ncbi.nlm.nih.gov/pubmed/34937145.