Efficacy and Safety of Remdesivir for COVID-19 Treatment: An Analysis of Randomized, Double-Blind, Placebo-Controlled Trials

  1. Yun Zhu
  2. Zhaowei Teng
  3. Lirong Yang
  4. Shuanglan Xu
  5. Jie Liu
  6. Yirong Teng
  7. Qinggang Hao
  8. Dake Zhao
  9. Xiaolan Li
  10. Sheng Lu
  11. Yong Zeng

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Abstract

BACKGROUND

Remdesivir, an inhibitor of viral RNA-dependent RNA polymerases, has been identified as a candidate for COVID-19 treatment. However, the therapeutic effect of remdesivir is controversial.

METHODS

We searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials, from inception to June 11, 2020 for randomized controlled trials on the clinical efficacy of remdesivir. The main outcomes were discharge rate, mortality, and adverse events. This study is registered at INPLASY (INPLASY202060046).

RESULTS

Data of 1075 subjects showed that remdesivir significantly increased the discharge rate of patients with COVID-19 compared with the placebo (50.4% vs. 45.29%; relative risk [RR] 1.19 [95% confidence interval [CI], 1.05–1.34], I 2 = 0.0%, P = 0.754). It also significantly decreased mortality (8.18% vs. 12.70%; RR 0.64 [95% CI, 0.44–0.92], I 2 = 45.7%, P = 0.175) compared to the placebo. Data of 1296 subjects showed that remdesivir significantly decreased the occurrence of serious adverse events (RR 0.77 [95% CI, 0.63–0.94], I 2 = 0.0%, P = 0.716).

CONCLUSION

Remdesivir is efficacious and safe for the treatment of COVID-19.

TRIAL REGISTRATION NUMBER

This study is registered at the International Platform of Registered Systematic Review and Meta-analysis Protocols (INPLASY202060046).

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  1. ScreenIT

    SciScore for 10.1101/2020.06.22.20136531: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    RandomizationStudies were considered eligible if they met the following criteria: (1) presented original data from a randomized, double-blind, placebo-controlled trial; (2) used two comparator groups with one receiving remdesivir and the other receiving a placebo; (3) reported the number of patients discharged from hospital, death, and adverse events as outcomes; and (4) had adequate data to be pooled for the analysis.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    SEARCH STRATEGY AND CRITERIA: We systematically searched PubMed, Embase, and the Cochrane Central Register of Controlled Trials from their inception to June 11, 2020, to identify RCTs on remdesivir treatment for COVID-19, with no restrictions on publication type or language.
    PubMed
    suggested: (PubMed, RRID:SCR_004846)
    Embase
    suggested: (EMBASE, RRID:SCR_001650)
    STATA software v12.0 (College Station, TX, USA) was used to analyze the data.
    STATA
    suggested: (Stata, RRID:SCR_012763)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).

    Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
    Our analysis had some limitations. First, the small number of studies that were included greatly weakened the reliability of our results. Second, the RR values calculated were unadjusted owing to a lack of raw data, which may lead to bias. Third, the overall sample size is not large enough, which limits statistical power. Thus, larger-scale RCTs are needed, and our pooled analysis findings should be interpreted with caution. However, we will update the analysis as new studies that meet inclusion criteria emerge. Overall, this analysis demonstrated that remdesivir significantly increased the recovery rate, decreased mortality, and decreased the risk of serious adverse events. Our findings highlight the efficacy and safety of remdesivir for the treatment of COVID-19, which should be incorporated into routine therapy. Furthermore, this analysis also suggests that larger cohorts and randomized controlled trials are needed to more thoroughly investigate the treatment efficacy and safety of remdesivir for COVID-19.

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

    Results from JetFighter: We did not find any issues relating to colormaps.

    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.

  2. Version published to 10.1101/2020.06.22.20136531v1 on medRxiv