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Review
. 2023 Jan 25;1(1):CD014962.
doi: 10.1002/14651858.CD014962.pub2.

Remdesivir for the treatment of COVID-19

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

Remdesivir for the treatment of COVID-19

Felicitas Grundeis et al. Cochrane Database Syst Rev. .

Abstract

Background: Remdesivir is an antiviral medicine approved for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19). This led to widespread implementation, although the available evidence remains inconsistent. This update aims to fill current knowledge gaps by identifying, describing, evaluating, and synthesising all evidence from randomised controlled trials (RCTs) on the effects of remdesivir on clinical outcomes in COVID-19.

Objectives: To assess the effects of remdesivir and standard care compared to standard care plus/minus placebo on clinical outcomes in patients treated for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

Search methods: We searched the Cochrane COVID-19 Study Register (which comprises the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, ClinicalTrials.gov, World Health Organization (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 31 May 2022.

Selection criteria: We followed standard Cochrane methodology. We included RCTs evaluating remdesivir and standard care for the treatment of SARS-CoV-2 infection compared to standard care plus/minus placebo 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 (Grading of Recommendations, Assessment, Development and Evaluation) approach for outcomes that were reported according to our prioritised categories: all-cause mortality, in-hospital mortality, clinical improvement (being alive and ready for discharge up to day 28) or worsening (new need for invasive mechanical ventilation or death up to day 28), quality of life, serious adverse events, and adverse events (any grade). We differentiated between non-hospitalised individuals with asymptomatic SARS-CoV-2 infection or mild COVID-19 and hospitalised individuals with moderate to severe COVID-19.

Main results: We included nine RCTs with 11,218 participants diagnosed with SARS-CoV-2 infection and a mean age of 53.6 years, of whom 5982 participants were randomised to receive remdesivir. Most participants required low-flow oxygen at baseline. Studies were mainly conducted in high- and upper-middle-income countries. We identified two studies that are awaiting classification and five ongoing studies. Effects of remdesivir in hospitalised individuals with moderate to severe COVID-19 With moderate-certainty evidence, 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 6 more; 4 studies, 7142 participants), day 60 (RR 0.85, 95% CI 0.69 to 1.05; RD 35 fewer per 1000, 95% CI 73 fewer to 12 more; 1 study, 1281 participants), or in-hospital mortality at up to day 150 (RR 0.93, 95% CI 0.84 to 1.03; RD 11 fewer per 1000, 95% CI 25 fewer to 5 more; 1 study, 8275 participants). Remdesivir probably increases the chance of clinical improvement at up to day 28 slightly (RR 1.11, 95% CI 1.06 to 1.17; RD 68 more per 1000, 95% CI 37 more to 105 more; 4 studies, 2514 participants; moderate-certainty evidence). It probably decreases the risk of clinical worsening within 28 days (hazard ratio (HR) 0.67, 95% CI 0.54 to 0.82; RD 135 fewer per 1000, 95% CI 198 fewer to 69 fewer; 2 studies, 1734 participants, moderate-certainty evidence). Remdesivir may make little or no difference to the rate of adverse events of any grade (RR 1.04, 95% CI 0.92 to 1.18; RD 23 more per 1000, 95% CI 46 fewer to 104 more; 4 studies, 2498 participants; low-certainty evidence), or serious adverse events (RR 0.84, 95% CI 0.65 to 1.07; RD 44 fewer per 1000, 95% CI 96 fewer to 19 more; 4 studies, 2498 participants; low-certainty evidence). We considered risk of bias to be low, with some concerns for mortality and clinical course. We had some concerns for safety outcomes because participants who had died did not contribute information. Without adjustment, this leads to an uncertain amount of missing values and the potential for bias due to missing data. Effects of remdesivir in non-hospitalised individuals with mild COVID-19 One of the nine RCTs was conducted in the outpatient setting and included symptomatic people with a risk of progression. No deaths occurred within the 28 days observation period. We are uncertain about clinical improvement due to very low-certainty evidence. Remdesivir probably decreases the risk of clinical worsening (hospitalisation) at up to day 28 (RR 0.28, 95% CI 0.11 to 0.75; RD 46 fewer per 1000, 95% CI 57 fewer to 16 fewer; 562 participants; moderate-certainty evidence). We did not find any data for quality of life. Remdesivir may decrease the rate of serious adverse events at up to 28 days (RR 0.27, 95% CI 0.10 to 0.70; RD 49 fewer per 1000, 95% CI 60 fewer to 20 fewer; 562 participants; low-certainty evidence), but it probably makes little or no difference to the risk of adverse events of any grade (RR 0.91, 95% CI 0.76 to 1.10; RD 42 fewer per 1000, 95% CI 111 fewer to 46 more; 562 participants; moderate-certainty evidence). We considered risk of bias to be low for mortality, clinical improvement, and safety outcomes. We identified a high risk of bias for clinical worsening.

Authors' conclusions: Based on the available evidence up to 31 May 2022, remdesivir probably has little or no effect on all-cause mortality or in-hospital mortality of individuals with moderate to severe COVID-19. The hospitalisation rate was reduced with remdesivir in one study including participants with mild to moderate COVID-19. It may be beneficial in the clinical course for both hospitalised and non-hospitalised patients, but certainty remains limited. The applicability of the evidence to current practice may be limited by the recruitment of participants from mostly unvaccinated populations exposed to early variants of the SARS-CoV-2 virus at the time the studies were undertaken. Future studies should provide additional data on the efficacy and safety of remdesivir for defined core outcomes in COVID-19 research, especially for different population subgroups.

Trial registration: ClinicalTrials.gov NCT04280705 NCT04501952 NCT04292730 NCT04257656 NCT04330690 NCT04321616 NCT04315948 NCT04647669 NCT05024006 NCT04345419 NCT04596839 NCT04745351 NCT04252664 NCT04843761 NCT04978259.

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Conflict of interest statement

FG: works as an Intensive Care Medicine Consultant and is member of the CEOsys project. The latter was funded in 2021 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.

KA: is member of the CEOsys project, which was funded in 2021 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, which was funded in 2021 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.

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

MIM: is member of the CEOsys project, which was funded in 2021 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 part of Cochrane Metabolic and Endocrine Disorders; she was not part of the editorial process.

NS: none known; she is Co‐ordinating Editor of Cochrane Haematology, but was not involved in the editorial process for this review.

CB: none known.

AM: has no relevant conflicts of interest to declare. Affiliation with not‐for‐profit organisation: co‐ordination of Section COVRIIN and work in Office of STAKOB (Competence and Treatment Centres for high consequence infectious diseases) at Robert Koch Institute Centre for Biological Threats and Special Pathogens (ZBS), Section Clinical Management and Infection Control.

MG: works as an Intensive Care Medicine Consultant and is member of the CEOsys project, which was funded in 2021 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.

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

MS: has no known conflicts of interest to declare.

Figures

1
1
1.1
1.1. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 1: All‐cause mortality at up to day 28
1.2
1.2. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 2: All‐cause mortality at up to day 60
1.3
1.3. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 3: In‐hospital mortality at up to day 150
1.4
1.4. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 4: All‐cause mortality (time‐to‐event)
1.5
1.5. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 5: Clinical improvement: alive and ready to discharge
1.6
1.6. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 6: Clinical improvement: alive and ready to discharge (time‐to‐event)
1.7
1.7. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 7: Clinical worsening: new need for invasive mechanical ventilation or death
1.8
1.8. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 8: Clinical worsening: new need for invasive mechanical ventilation or death (time‐to‐event)
1.9
1.9. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 9: Adverse events, any grade
1.10
1.10. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 10: Adverse events, grade 3 to 4
1.11
1.11. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 11: Serious adverse events
1.12
1.12. Analysis
Comparison 1: Remdesivir and standard care versus standard care (plus/minus placebo) in moderate to severe COVID‐19, Outcome 12: Ventilator‐free days at day 28
2.1
2.1. Analysis
Comparison 2: Subgroup analysis (age of participants): remdesivir and standard care versus standard care (plus/minus placebo), 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 and standard care versus standard care (plus/minus placebo), Outcome 1: All‐cause mortality at up to day 28
4.1
4.1. Analysis
Comparison 4: Subgroup analysis (severity of condition, based on respiratory support at baseline): remdesivir and standard care versus standard care (plus/minus placebo), Outcome 1: All‐cause mortality at up to day 28
4.2
4.2. Analysis
Comparison 4: Subgroup analysis (severity of condition, based on respiratory support at baseline): remdesivir and standard care versus standard care (plus/minus placebo), Outcome 2: In‐hospital mortality at up to day 150
5.1
5.1. Analysis
Comparison 5: Subgroup analysis (duration of remdesivir application): remdesivir and standard care versus standard care (plus/minus placebo), Outcome 1: All‐cause mortality at up to day 28
6.1
6.1. Analysis
Comparison 6: Remdesivir and standard care versus standard care (plus/minus placebo) in mild COVID‐19, Outcome 1: All‐cause mortality at up to day 28
6.2
6.2. Analysis
Comparison 6: Remdesivir and standard care versus standard care (plus/minus placebo) in mild COVID‐19, Outcome 2: Clinical improvement: symptom alleviation at up to day 14
6.3
6.3. Analysis
Comparison 6: Remdesivir and standard care versus standard care (plus/minus placebo) in mild COVID‐19, Outcome 3: Clinical worsening: admission to hospital or death at up to day 28
6.4
6.4. Analysis
Comparison 6: Remdesivir and standard care versus standard care (plus/minus placebo) in mild COVID‐19, Outcome 4: Serious adverse events
6.5
6.5. Analysis
Comparison 6: Remdesivir and standard care versus standard care (plus/minus placebo) in mild COVID‐19, Outcome 5: Adverse events, any grade
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    1. CTRI/2021/12/039011. A study to assess the safety and efficacy of remdesivir in COVID-19 infected Indian patients. trialsearch.who.int/Trial2.aspx?TrialID=CTRI/2021/12/039011 (first received 29 December 2021).
CTRI/2022/03/041252 {published data only}
    1. CTRI/2022/03/041252. A clinical study to understand the effect of remdesivir intravenous injection in hospitalised moderate to severe COVID-19 patients. www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=65800 (first received 22 March 2022).
Deresinski 2020 {published data only}
    1. Deresinski S. Remdesivir and COVID-19. Infectious Disease Alert 2020;39(10).
Elliott 2020 {published data only}
    1. Elliott W, Chan J. Remdesivir injection. Internal Medicine Alert 2020;42(11).
Elliott 2021 {published data only}
    1. Elliot W, Chan J. Remdesivir injection and baricitinib tablets. Internal Medicine Alert 2021.
EUCTR2020‐000841‐15‐ES {published data only}
    1. EUCTR2020-000841-15-ES. A phase 3 randomised study to evaluate the safety and antiviral activity of remdesivir (GS-5734™) in participants with severe COVID-19 [Estudio de fase 3 aleatorizado para evaluar la seguridad y la actividad antiviral de remdesivir (GS-5734™) en participantes con infección grave por el COVID-19]. www.clinicaltrialsregister.eu/ctr-search/trial/2020-000841-15/ES (first received 11 March 2020).
EUCTR2020‐000936‐23 {published data only}
    1. EUCTR2020-000936-23. Multi-centre, adaptive, randomised trial of the safety and efficacy of treatments of COVID-19 in hospitalised adults - DisCoVeRy. www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:202... (first received 9 March 2020).
Euctr2020‐003510‐12‐dk {published data only}
    1. EUCTR2020-003510-12-DK. A study to test a drug named remdesivir to evaluate the efficacy and safety of the drug in treating patients with COVID-19 in an outpatient setting (non-hospitalised). www.clinicaltrialsregister.eu/ctr-search/search?query=EUCTR2020-003510-1... (first received 31 August 2020).
EUCTR2020‐004928‐42‐HU {published data only}
    1. EUCTR2020-004928-42-HU. Clinical trial of remdesivir in COVID-19 patients. https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-004928-42/HU (first received 12 October 2020). [EUCTR: 2020-004928-42]
Goldberg 2021 {published data only}
    1. Goldberg E, Ben Zvi H, Sheena L, Sofer S, Krause I, Sklan EH, et al. A real-life setting evaluation of the effect of remdesivir on viral load in COVID-19 patients admitted to a large tertiary centre in Israel. Clinical Microbiology and Infection 2021;27:917.e1-e4. - PMC - PubMed
Goldman 2020 {published data only}
    1. Goldman JD, Lye DCB, Hui DS, Marks KM, Bruno R, Montejano R, et al. Remdesivir for 5 or 10 days in patients with severe COVID-19. New England Journal of Medicine 2020;383:1827-37. [CLINICALTRIALS.GOV: NCT04292899] [DOI: 10.1056/NEJMoa2015301] - DOI - PMC - PubMed
    1. ISRCTN15874265. Study to assess the safety and effectiveness of remdesivir in people with severe COVID-19. www.isrctn.com/ISRCTN15874265 (first received 29 October 2020).
    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).
Goldman 2020a {published data only}
    1. Goldman JD, Lye DCB, Hui DS‐C, Marks K, Bruno R, Montejano R, et al. Impact of baseline alanine aminotransferase levels on the safety and efficacy of remdesivir in severe COVID-19 patients. Hepatology 2020;72:279A.
Grein 2020 {published data only}
    1. Grein J, Ohmagari N, Shin D, Diaz G, Asperges E, Castagna A, et al. Compassionate use of remdesivir for patients with severe COVID-19. New England Journal of Medicine 2020;382(24):2327-36. [DOI: 10.1056/NEJMoa2007016] - DOI - PMC - PubMed
Grundmann 2022 {published data only}
    1. Grundmann A, Wu C, Hardwick M, Baillie JK, Openshaw P, Semple MG, et al. Impact of dexamethasone and remdesivir on neurological complications during COVID-19 (preprint). SSRN 2022. - PMC - PubMed
IRCT20151227025726N28 {published data only}
    1. IRCT20151227025726N28. Evaluating the effects of remdesivir in severe COVID-19 in hospitalised patients. trialsearch.who.int/Trial2.aspx?TrialID=IRCT20151227025726N28 (first received 21 October 2021).
IRCT20210324050760N1 {published data only}
    1. IRCT20210324050760N1. Effect of remdesivir in treatment of COVID-19. trialsearch.who.int/Trial2.aspx?TrialID=IRCT20210324050760N1 (first received 21 April 2021).
ISRCTN15874265 {published data only}
    1. ISRCTN15874265. Study to assess the safety and effectiveness of remdesivir in people with severe COVID-19. www.isrctn.com/ISRCTN15874265 (first received 29 October 2020).
ISRCTN85762140 {published data only}
    1. ISRCTN85762140. Study to assess the safety and effectiveness of remdesivir in people with moderate COVID-19. www.isrctn.com/ISRCTN85762140 (first received 2 November 2020).
Jang 2021 {published data only}
    1. Jang Y, Shin JS, Lee MK, Jung E, An T, Kim U, et al. Comparison of antiviral activity of gemcitabine with 2′-gluoro-2′-deoxycytidine and combination therapy with remdesivir against SARS-CoV-2. International Journal of Molecular Sciences 2021;22(4):1581-96. - PMC - PubMed
Kalil 2021 {published data only}
    1. Elliott W, Chan J. Remdesivir injection and baricitinib tablets. Internal Medicine Alert 2021;43(1).
    1. Kalil AC, Patterson TF, Mehta AK, Tomashek KM, Wolfe CR, Ghazaryan V, ACTT-2 study group members. Baricitinib plus remdesivir for hospitalized adults with COVID-19. New England Journal of Medicine 2020;384(9):795-807. [CLINICALTRIALS.GOV: NCT04401579] [DOI: 10.1056/NEJMoa2031994] - DOI - PMC - PubMed
    1. NCT04401579. Adaptive COVID-19 treatment trial 2 (ACTT-2). clinicaltrials.gov/ct2/show/NCT04401579 (first received 26 May 2020).
Lapadula 2020 {published data only}
    1. Lapadula G, Bernasconi DP, Bellani G, Soria A, Rona R, Bombino M, et al. Remdesivir use in patients requiring mechanical ventilation due to COVID-19. Open Forum Infectious Diseases 2020;7(11):ofaa481. [DOI: 10.1093/ofid/ofaa481] - DOI - PMC - PubMed
LBCTR2020043495 {published data only}
    1. LBCTR2020043495. An international randomised trial of additional treatments for COVID-19 in hospitalised patients who are all receiving the local standard of care. https://lbctr.moph.gov.lb/Trials/Details/4522 (first received 22 April 2020). [LBCTR: 2020043495]
Medical Brief {published data only}
    1. Medical Brief. Remdesivir for COVID-19 improves time to recovery – peer-reviewed adaptive COVID-19 teatment trial. www.medicalbrief.co.za/archives/remdesivir-for-covid-19-improves-time-to... 2020;304.
NCT04252664a {published data only}
    1. NCT04252664. A trial of remdesivir in adults with mild and moderate COVID-19. clinicaltrials.gov/ct2/show/NCT04252664 (first received 5 February 2020).
NCT04256395 {published data only}
    1. NCT04256395. Efficacy of a self-test and self-alert mobile applet in detecting susceptible infection of COVID-19 (COVID-19). clinicaltrials.gov/ct2/show/NCT04256395 (first received 5 February 2020).
NCT04280705 {published data only}
    1. NCT04280705. Adaptive COVID-19 treatment trial (ACTT). clinicaltrials.gov/ct2/show/NCT04280705 (first received 21 February 2020).
NCT04292899 {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).
NCT04302766 {published data only}
    1. NCT04302766. Expanded access remdesivir (RDV; GS-5734™). clinicaltrials.gov/ct2/show/NCT04302766 (first received 10 March 2020).
NCT04321928 {published data only}
    1. NCT04321928. Personalised health education against the health damage of novel coronavirus (COVID-19) outbreak in Hungary (PROACTIVE-19). clinicaltrials.gov/ct2/show/NCT04321928 (first received 25 March 2020).
NCT04323761 {published data only}
    1. NCT04323761. Expanded access treatment protocol: temdesivir (RDV; GS-5734) for the treatment of SARS-CoV2 (CoV) infection (COVID-19). clinicaltrials.gov/ct2/show/NCT04323761 (first received 27 March 2020).
NCT04353596 {published data only}
    1. NCT04353596. Stopping ACE-inhibitors in COVID-19 (ACEI-COVID). clinicaltrials.gov/ct2/show/record/NCT04353596?view=record (first received 20 April 2020).
NCT04401579 {published data only}
    1. NCT04401579. Adaptive COVID-19 treatment trial 2 (ACTT-2). clinicaltrials.gov/ct2/show/NCT04401579 (first received 26 May 2020).
NCT04410354 {published data only}
    1. NCT04410354. Study of merimepodib in combination with remdesivir in adult patients with advanced COVID-19. clinicaltrials.gov/ct2/show/NCT04410354 (first received 1 June 2020).
NCT04480333 {published data only}
    1. NCT04480333. Safety, tolerability and pharmacokinetics of inhaled nanoparticle formulation of remdesivir (GS-5734) and NA-831. clinicaltrials.gov/ct2/show/NCT04480333 (first received 21 July 2020).
NCT04488081 {published data only}
    1. NCT04488081. I-SPY COVID-19 trial: an adaptive platform trial for critically ill patients (I-SPY_COVID). clinicaltrials.gov/ct2/show/NCT04488081 (first received 27 July 2020).
NCT04492475 {published data only}
    1. NCT04492475. Adaptive COVID-19 treatment trial 3 (ACTT-3). clinicaltrials.gov/ct2/show/NCT04492475 (first received 30 July 2020).
NCT04501978 {published data only}
    1. NCT04501978. ACTIV-3: therapeutics for inpatients with COVID-19 (TICO). clinicaltrials.gov/ct2/show/NCT04501978 (first received 6 August 2020).
NCT04518410 {published data only}
    1. NCT04518410. ACTIV-2: a study for outpatients with COVID-19. clinicaltrials.gov/ct2/show/NCT04518410 (first received 19 August 2020).
NCT04539262 {published data only}
    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).
NCT04610541 {published data only}
    1. NCT04610541. REMdesivir-HU clinical study and severe COVID-19 patients. clinicaltrials.gov/ct2/show/NCT04610541 (first received 30 October 2020).
NCT04640168 {published data only}
    1. NCT04640168. Adaptive COVID-19 treatment trial 4 (ACTT-4). clinicaltrials.gov/ct2/show/NCT04640168 (first received 23 November 2020).
NCT04647695 {published data only}
    1. NCT04647695. IFN-beta 1b and remdesivir for COVID19. clinicaltrials.gov/ct2/show/NCT04647695 (first received 1 December 2020).
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).
NCT04746183 {published data only}
    1. NCT04746183. AGILE (early phase platform trial for COVID-19). clinicaltrials.gov/ct2/show/NCT04746183 (first received 9 February 2021).
NCT04832880 {published data only}
    1. NCT04832880. Factorial randomised trial of rendesivir and baricitinib plus dexamethasone for COVID-19 (the AMMURAVID Trial) (AMMURAVID). clinicaltrials.gov/ct2/show/NCT04832880 (first received 6 April 2021).
NCT04847622 {published data only}
    1. NCT04847622. Study to evaluate the clinical outcomes in adults with COVID-19 who have been treated with remdesivir. clinicaltrials.gov/ct2/show/NCT04847622 (first received 19 April 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;73(11):e4166-74. [CLINICALTRIALS.GOV: NCT04292899] [DOI: 10.1093/cid/ciaa1041] [EUPAS: EUPAS34303] - DOI - PMC - PubMed
Olender 2021 {published data only}
    1. Olender SA, Waluna TL, Martinez E, Perez KK, Castana A, Wang S, et al. Remdesivir versus standard-of-care for severe coronavirus disease 2019 infection: an analysis of 28-day mortality. Open Forum Infectious Diseases 2021;8(7):ofab278. [DOI: 10.1093/ofid/ofab278] - DOI - PMC - PubMed
Padilla 2022 {published data only}
    1. Padilla S, Polotskaya K, Fernández M, Gonzalo-Jiménez N, la Rica A, García JA, et al. Survival benefit of remdesivir in hospitalised COVID-19 patients with high SARS-CoV-2 viral loads and low-grade systemic inflammation. Journal of Antimicrobial Chemotherapy 2022;77:2257-64. [DOI: 10.1093/jac/dkac144] - DOI - 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
PER‐101‐20 {published data only}
    1. PER-101-20. Randomised master protocol for immune modulators for treating COVID-19. www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=101-20 (first received 30 December 2020).
Rosas 2021 {published data only}
    1. NCT04409262. A study to evaluate the efficacy and safety of remdesivir plus tocilizumab compared with remdesivir plus placebo in hospitalised participants with severe COVID-19 pneumonia (REMDACTA). clinicaltrials.gov/ct2/show/NCT04409262 (first received 1 June 2020).
    1. Rosas IO, Diaz G, Gottlieb RL, Lobo SM, Robinson P, Hunter BD, et al. Tocilizumab and remdesivir in hospitalized patients with severe COVID-19 pneumonia: a randomized clinical trial. Intensive Care Medicine 2021;47(11):1258-70. [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
Shakir 2022 {published data only}
    1. Shakir A, Bhasin N, Swami R, Mehta K, Sinha S, Ali SS, et al. Renal and hepatic outcomes after remdesivir therapy in coronavirus disease-2019-positive patients with renal dysfunction at baseline or after starting therapy. Saudi Journal of Kidney Diseases and Transplantation 2021;32(4):1034-42. - 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).
Winstead 2021 {published data only}
    1. Winstead RJ, Christensen J, Sterling S, Morales M, Kumar D, Bryson A, et al. Effect of remdesivir on COVID-19 PCR positivity and cycle threshold in kidney transplant recipients. Transplantology 2021;2(3):291-3. [DOI: 10.3390/transplantology2030028] - DOI

References to studies awaiting assessment

NCT04596839 {published data only}
    1. NCT04596839. Antiviral activity and safety of remdesivir in Bangladeshi patients with severe coronavirus disease (COVID-19). https://clinicaltrials.gov/ct2/show/NCT04596839 (first received 22 October 2020).
REDPINE 2022 {published data only}EUCTR2020‐005416‐22
    1. EUCTR2020-005416-22. A phase 3 study of remdesivir in participants with severe renal impairment who are in hospital for COVID-19. www.clinicaltrialsregister.eu/ctr-search/trial/2020-005416-22/PT#P (first received 24 February 2021).
    1. NCT04745351. Study to evaluate the efficacy and safety of remdesivir in participants with severely reduced kidney function who are hospitalised for coronavirus disease 2019 (COVID-19) (REDPINE). clinicaltrials.gov/ct2/show/NCT04745351 (first received 9 February 2021).

References to ongoing studies

IRCT20210709051824N1 {published data only}IRCT20210709051824N1
    1. IRCT20210709051824N1. Assessment of utility of remdesivir in patients with acute kidney injury or cronic kidney disease in admitted COVID-19 patients. trialsearch.who.int/Trial2.aspx?TrialID=IRCT20210709051824N1 (first received 22 December 2021).
NCT04252664 {published data only}
    1. NCT04252664. A trial of remdesivir in adults with mild and moderate COVID-19. clinicaltrials.gov/ct2/show/NCT04252664 (first received 5 February 2020).
NCT04351724 {published data only}
    1. NCT04351724. Austrian coronavirus adaptive clinical trial (COVID-19) (ACOVACT). clinicaltrials.gov/ct2/show/NCT04351724 (first received 17 April 2020).
NCT04843761 {published data only}
    1. NCT04843761. ACTIV-3b: therapeutics for severely ill inpatients with COVID-19 (TESICO). clinicaltrials.gov/ct2/show/NCT04843761 (first received 14 April 2021).
NCT04978259 {published data only}
    1. NCT04978259. Long-term follow-up of a randomised multicenter trial on impact of long-COVID in hospitalised COVID-19 patients. clinicaltrials.gov/ct2/show/NCT04978259 (first received 27 July 2021).

Additional references

Al‐Abdouh 2021
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Angamo 2022
    1. Anagamo MT, Mohammed MA, Peterson GM. Efficacy and safety of remdesivir in hospitalised COVID-19 patients: a systematic review and meta-analysis. Infection 2022;50(1):27-41. [DOI: 10.1007/s15010-021-01671-0] - DOI - PMC - PubMed
Beckermann 2022
    1. Beckermann R, Gori A, Jeyakumar S, Malin JJ, Paredes R, Póvoa P, et al. Remdesivir for the treatment of patients hospitalized with COVID-19 receiving supplemental oxygen: a targeted literature review and meta-analysis. Scientific Reports 2022;12(1):9622. [DOI: 10.1038/s41598-022-13680-6] - DOI - PMC - PubMed
Brandal 2021
    1. Brandal LT, MacDonald E, Veneti L, Ravlo T, Lange H, Naseer U, et al. Outbreak caused by the SARS-CoV-2 Omicron variant in Norway, November to December 2021. Eurosurveillance 2021;26(50):2101147. [DOI: 10.2807/1560-7917.ES.2021.26.50.2101147] - DOI - PMC - PubMed
Buitrago‐Garcia 2022
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CDC 2022
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CEOsys 2021
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Choy 2020
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CRD42021238065
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Deeks 2020
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de Vries 2022
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de Wit 2020
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Eldridge 2016
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EMA 2020
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EUA 2021
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EUA 2022
    1. Emergency Use Authorization (EUA) for remdesivir, an unapproved product Center for Drug Evaluation and Research (CDER) Memorandum. https://www.fda.gov/media/155772/download (accessed 6 May 2022).
FDA 2022a
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FDA 2022b
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Associated data