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. 2021 Aug 5;8(8):CD014962.
doi: 10.1002/14651858.CD014962.

Remdesivir for the treatment of COVID-19

Kelly Ansems  1 , Felicitas Grundeis  2 , Karolina Dahms  1 , Agata Mikolajewska  3 , Volker Thieme  4 , Vanessa Piechotta  5 , Maria-Inti Metzendorf  6 , Miriam Stegemann  3 , Carina Benstoem  1 , Falk Fichtner  4
Affiliations

Remdesivir for the treatment of COVID-19

Kelly Ansems et al. Cochrane Database Syst Rev. .

Update in

  • Remdesivir for the treatment of COVID-19.
    Grundeis F, Ansems K, Dahms K, Thieme V, Metzendorf MI, Skoetz N, Benstoem C, Mikolajewska A, Griesel M, Fichtner F, Stegemann M. Grundeis F, et al. Cochrane Database Syst Rev. 2023 Jan 25;1(1):CD014962. doi: 10.1002/14651858.CD014962.pub2. Cochrane Database Syst Rev. 2023. PMID: 36695483 Free PMC article.

Abstract

Background: Remdesivir is an antiviral medicine with properties to inhibit viral replication of SARS-CoV-2. Positive results from early studies attracted media attention and led to emergency use authorisation of remdesivir in COVID-19. A thorough understanding of the current evidence regarding the effects of remdesivir as a treatment for SARS-CoV-2 infection based on randomised controlled trials (RCTs) is required.

Objectives: To assess the effects of remdesivir compared to placebo or standard care alone on clinical outcomes in hospitalised patients with SARS-CoV-2 infection, and to maintain the currency of the evidence using a living systematic review approach.

Search methods: We searched the Cochrane COVID-19 Study Register (which comprises the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform, and medRxiv) as well as Web of Science (Science Citation Index Expanded and Emerging Sources Citation Index) and WHO COVID-19 Global literature on coronavirus disease to identify completed and ongoing studies without language restrictions. We conducted the searches on 16 April 2021.

Selection criteria: We followed standard Cochrane methodology. We included RCTs evaluating remdesivir for the treatment of SARS-CoV-2 infection in hospitalised adults compared to placebo or standard care alone irrespective of disease severity, gender, ethnicity, or setting. We excluded studies that evaluated remdesivir for the treatment of other coronavirus diseases.

Data collection and analysis: We followed standard Cochrane methodology. To assess risk of bias in included studies, we used the Cochrane RoB 2 tool for RCTs. We rated the certainty of evidence using the GRADE approach for outcomes that were reported according to our prioritised categories: all-cause mortality at up to day 28, duration to liberation from invasive mechanical ventilation, duration to liberation from supplemental oxygen, new need for mechanical ventilation (high-flow oxygen or non-invasive or invasive mechanical ventilation), new need for invasive mechanical ventilation, new need for non-invasive mechanical ventilation or high-flow oxygen, new need for oxygen by mask or nasal prongs, quality of life, adverse events (any grade), and serious adverse events.

Main results: We included five RCTs with 7452 participants diagnosed with SARS-CoV-2 infection and a mean age of 59 years, of whom 3886 participants were randomised to receive remdesivir. Most participants required low-flow oxygen (n=4409) or mechanical ventilation (n=1025) at baseline. We identified two ongoing studies, one was suspended due to a lack of COVID-19 patients to recruit. Risk of bias was considered to be of some concerns or high risk for clinical status and safety outcomes because participants who had died did not contribute information to these outcomes. Without adjustment, this leads to an uncertain amount of missing values and the potential for bias due to missing data. Effects of remdesivir in hospitalised individuals Remdesivir probably makes little or no difference to all-cause mortality at up to day 28 (risk ratio (RR) 0.93, 95% confidence interval (CI) 0.81 to 1.06; risk difference (RD) 8 fewer per 1000, 95% CI 21 fewer to 7 more; 4 studies, 7142 participants; moderate-certainty evidence). Considering the initial severity of condition, only one study showed a beneficial effect of remdesivir in patients who received low-flow oxygen at baseline (RR 0.32, 95% CI 0.15 to 0.66, 435 participants), but conflicting results exists from another study, and we were unable to validly assess this observations due to limited availability of comparable data. Remdesivir may have little or no effect on the duration to liberation from invasive mechanical ventilation (2 studies, 1298 participants, data not pooled, low-certainty evidence). We are uncertain whether remdesivir increases or decreases the chance of clinical improvement in terms of duration to liberation from supplemental oxygen at up to day 28 (3 studies, 1691 participants, data not pooled, very low-certainty evidence). We are very uncertain whether remdesivir decreases or increases the risk of clinical worsening in terms of new need for mechanical ventilation at up to day 28 (high-flow oxygen or non-invasive ventilation or invasive mechanical ventilation) (RR 0.78, 95% CI 0.48 to 1.24; RD 29 fewer per 1000, 95% CI 68 fewer to 32 more; 3 studies, 6696 participants; very low-certainty evidence); new need for non-invasive mechanical ventilation or high-flow oxygen (RR 0.70, 95% CI 0.51 to 0.98; RD 72 fewer per 1000, 95% CI 118 fewer to 5 fewer; 1 study, 573 participants; very low-certainty evidence); and new need for oxygen by mask or nasal prongs (RR 0.81, 95% CI 0.54 to 1.22; RD 84 fewer per 1000, 95% CI 204 fewer to 98 more; 1 study, 138 participants; very low-certainty evidence). The evidence suggests that remdesivir may decrease the risk of clinical worsening in terms of new need for invasive mechanical ventilation (67 fewer participants amongst 1000 participants; RR 0.56, 95% CI 0.41 to 0.77; 2 studies, 1159 participants; low-certainty evidence). None of the included studies reported quality of life. Remdesivir probably decreases the serious adverse events rate at up to 28 days (RR 0.75, 95% CI 0.63 to 0.90; RD 63 fewer per 1000, 95% CI 94 fewer to 25 fewer; 3 studies, 1674 participants; moderate-certainty evidence). We are very uncertain whether remdesivir increases or decreases adverse events rate (any grade) (RR 1.05, 95% CI 0.86 to 1.27; RD 29 more per 1000, 95% CI 82 fewer to 158 more; 3 studies, 1674 participants; very low-certainty evidence).

Authors' conclusions: Based on the currently available evidence, we are moderately certain that remdesivir probably has little or no effect on all-cause mortality at up to day 28 in hospitalised adults with SARS-CoV-2 infection. We are uncertain about the effects of remdesivir on clinical improvement and worsening. There were insufficient data available to validly examine the effect of remdesivir on mortality in subgroups depending on the extent of respiratory support at baseline. Future studies should provide additional data on efficacy and safety of remdesivir for defined core outcomes in COVID-19 research, especially for different population subgroups. This could allow us to draw more reliable conclusions on the potential benefits and harms of remdesivir in future updates of this review. Due to the living approach of this work, we will update the review periodically.

Trial registration: ClinicalTrials.gov NCT04280705 NCT04292730 NCT04257656 NCT04315948 NCT04321616 NCT04330690 NCT04647669 NCT04252664 NCT04596839.

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Conflict of interest statement

KA: is member of the CEOsys project funded by the Network of University Medicine (Nationales Forschungsnetzwerk der Universitätsmedizin (NUM)) by the Federal Ministry of Education and Research of Germany (Bundesministerium für Bildung und Forschung (BMBF)), grant number 01KX2021, paid to the institution.

FG: works as an Intensive Care Medicine Consultant and is member of the CEOsys project funded by the Network of University Medicine (Nationales Forschungsnetzwerk der Universitätsmedizin (NUM)) by the Federal Ministry of Education and Research of Germany (Bundesministerium für Bildung und Forschung (BMBF)), grant number 01KX2021, paid to the institution.

KD: is member of the CEOsys project funded by the Network of University Medicine (Nationales Forschungsnetzwerk der Universitätsmedizin (NUM)) by the Federal Ministry of Education and Research of Germany (Bundesministerium für Bildung und Forschung (BMBF)), grant number 01KX2021, paid to the institution.

AM: none known.

VT: works as an Intensive Care Medicine Consultant and is member of the CEOsys project (no direct funding).

VP: is member of the CEOsys project funded by the Network of University Medicine (Nationales Forschungsnetzwerk der Universitätsmedizin (NUM)) by the Federal Ministry of Education and Research of Germany (Bundesministerium für Bildung und Forschung (BMBF)), grant number 01KX2021, paid to the institution.

MIM: is member of the CEOsys project funded by the Network of University Medicine (Nationales Forschungsnetzwerk der Universitätsmedizin (NUM)) by the Federal Ministry of Education and Research of Germany (Bundesministerium für Bildung und Forschung (BMBF)), grant number 01KX2021, paid to the institution.

MS: has no known conflicts of interest to declare.

CB: none known.

FF: works as an Intensive Care Medicine Consultant and is member of the CEOsys project (no direct funding).

Figures

1
1
1.1
1.1. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 1: All‐cause mortality at up to day 28
1.2
1.2. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 2: All‐cause mortality at hospital discharge
1.3
1.3. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 3: All‐cause mortality (time‐to‐event)
1.4
1.4. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 4: Worsening of clinical status: new need for mechanical ventilation
1.5
1.5. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 5: Worsening of clinical status: new need for invasive mechanical ventilation
1.6
1.6. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 6: Worsening of clinical status: new need for non‐invasive mechanical ventilation or high‐flow oxygen
1.7
1.7. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 7: Worsening of clinical status: new need for oxygen by mask or nasal prongs
1.8
1.8. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 8: Viral clearance
1.9
1.9. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 9: Serious adverse events
1.10
1.10. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 10: Adverse events, any grade
1.11
1.11. Analysis
Comparison 1: Remdesivir versus placebo or standard care alone, Outcome 11: Adverse events, grade 3 to 4
2.1
2.1. Analysis
Comparison 2: Subgroup analysis (age of participants): remdesivir versus placebo or standard care alone, Outcome 1: All‐cause mortality at up to day 28
3.1
3.1. Analysis
Comparison 3: Subgroup analysis (timing of first dose administration with illness onset): remdesivir versus placebo or standard care alone, Outcome 1: All‐cause mortality at up to day 28
4.1
4.1. Analysis
Comparison 4: Subgroup analysis (severity of condition, no oxygen versus low‐flow oxygen versus mechanical ventilation (including high‐flow oxygen, non‐invasive ventilation, invasive mechanical ventilation, and ECMO): remdesivir versus placebo or standard care alone, Outcome 1: All‐cause mortality at up to day 28
5.1
5.1. Analysis
Comparison 5: Subgroup analysis (duration of remdesivir application): remdesivir versus placebo or standard care alone, Outcome 1: All‐cause mortality at up to day 28
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    1. NCT04539262. Study in participants with early stage coronavirus disease 2019 (COVID-19) to evaluate the safety, efficacy, and pharmacokinetics of remdesivir administered by inhalation. clinicaltrials.gov/ct2/show/NCT04539262 (first received 4 September 2020).
NCT04583956 {published data only}
    1. NCT04583956. ACTIV-5 / big effect trial (BET-A) for the treatment of COVID-19. clinicaltrials.gov/ct2/show/NCT04583956 (first received 12 October 2020).
NCT04583969 {published data only}
    1. NCT04583969. ACTIV-5 / big effect trial (BET-B) for the treatment of COVID-19. clinicaltrials.gov/ct2/show/NCT04583969 (first received 12 October 2020).
NCT04640168 {published data only}
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NCT04647695 {published data only}
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NCT04678739 {published data only}
    1. NCT04678739. Efficacy and safety of remdesivir and tociluzumab for the management of severe COVID-19: a randomised controlled trial. clinicaltrials.gov/ct2/show/NCT04678739 (first received 22 December 2020).
NCT04693026 {published data only}
    1. NCT04693026. Efficacy of remdisivir and Baricitinib for the treatment of severe COVID 19 patients. clinicaltrials.gov/ct2/show/NCT04693026 (first received 5 January 2021).
NCT04713176 {published data only}
    1. NCT04713176. Efficacy and safety of DWJ1248 with remdesivir in severe COVID-19 patients. clinicaltrials.gov/ct2/show/NCT04713176 (first received 19 January 2021).
NCT04728880 {published data only}
    1. NCT04728880. Remdesivir in adults with COVID-19: Mansoura university hospital experience. clinicaltrials.gov/ct2/show/NCT04728880 (first received 28 January 2021).
Olender 2020 {published data only}
    1. NCT04292899. Study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with severe coronavirus disease (COVID-19). clinicaltrials.gov/ct2/show/NCT04292899 (first received 3 March 2020).
    1. Olender SA, Perez KK, Go AS, Balani B, Price-Haywood EG, Shah NS, et al. Remdesivir for severe coronavirus disease 2019 (COVID- 19) versus a cohort receiving standard of care. Clinical Infectious Diseases 2020;ciaa1041. [CLINICALTRIALS.GOV: NCT04292899] [DOI: 10.1093/cid/ciaa1041] [EUPAS: EUPAS34303] - DOI - PMC - PubMed
Pan 2020 {published data only}
    1. Pan H, Peto R, Karim QA, Alejandria M, Henao-Restrepo AM, García CH, WHO Solidarity trial consortium. Repurposed antiviral drugs for COVID-19 –interim WHO SOLIDARITY trial results. medRxiv 2020;384:497-511. [DOI: 10.1101/2020.10.15.20209817] [ISRCTN83971151] [NCT04315948] - DOI - PMC - PubMed
Pan 2021 {published data only}
    1. Pan H, Peto R, Henao-Restrepo AM, Preziosi MP, Sathiyamoorthy V, Karim QA, WHO Solidarity Trial Consortium. Repurposed antiviral drugs for COVID-19 - Interim WHO solidarity trial results. New England Journal of Medicine 2021;384:497-511. [DOI: 10.1056/NEJMoa2023184] [EUCTR2020-001366-11] [ISRCTN83971151] [NCT04315948] - DOI - PMC - PubMed
Saito 2020 {published data only}
    1. Saito S, Hayakawa K, Mikami A, Izumi S, Funazaki H, Ashida S, et al. Investigator initiated clinical trial of remdesivir for the treatment of COVID-19 in Japan. Global Health & Medicine 2021;3:62-6. [DOI: 10.35772/ghm.2020.01106] - DOI - PMC - PubMed
Shih 2020 {published data only}
    1. Shih WCJ, Yao C, Xie T. Data monitoring for the Chinese clinical trials of remdesivir in treating patients with COVID-19 during the pandemic crisis. Therapeutic Innovation & Regulatory Science 2020;54(5):1236-55. [DOI: 10.1007/s43441-020-00159-7] - DOI - PMC - PubMed
Soto 2020 {published data only}
    1. Soto A, Quiñones-Laveriano DM, Garcia PJ, Gotuzzo E, Henao-Restrepo AM. Rapid responses to the COVID-19 pandemic through science and global collaboration: the solidarity clinical trial [Respuestas rápidas a la pandemia de COVID-19 a través de la ciencia y la colaboración global: el ensayo clínico solidaridad]. Revista Peruana de Medicina Experimental y Salud Pública 2020;37:356-60. [DOI: 10.17843/rpmesp.2020.372.5546] - DOI - PubMed
Sun 2020 {published data only}
    1. Sun D. Remdesivir for treatment of COVID-19: combination of pulmonary and IV administration may offer additional benefit. AAPS Journal 2020;22:1-6. [DOI: 10.1208/s12248-020-00459-8] - DOI - PMC - PubMed
Tran 2020 {published data only}
    1. Tran B. Early data on remdesivir for severe COVID-19: a promising start? Internal Medicine Alert 2020;42(13).

References to ongoing studies

NCT04252664 {published data only}
    1. A trial of remdesivir in adults with mild and moderate COVID-19. https://clinicaltrials.gov/ct2/show/NCT04252664.
NCT04596839 {published data only}
    1. Antiviral activity and safety of remdesivir in Bangladeshi patients with severe coronavirus disease (COVID-19). https://clinicaltrials.gov/ct2/show/NCT04596839.

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