Another step toward final call on Remdesivir efficacy as a treatment for hospitalized COVID-19 patients: a multicenter open-label trial

  1. Hamed Hosseini
  2. Anahita Sadeghi
  3. Payam Tabarsi
  4. Azin Etemadimanesh
  5. Ilad Alavi Darazam
  6. Nasser Aghdami
  7. Saeed Kalantari
  8. Mehrdad Hasibi
  9. Azar Hadadi
  10. Farhang Babamahmoodi
  11. Mansooreh Momen-Heravi
  12. Ahmad Hormati
  13. Yunes Panahi
  14. Rozita Khodashahi
  15. Mohammadreza Salehi

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Abstract

Introduction

After emerging the global pandemic of SARS-CoV2 some preliminary studies demonstrated the efficacy of antiviral treatments. But shortly thereafter, inconsistencies in the results of further clinical trials raised doubts on the efficacy of these agents. In this study, we aimed to evaluate the effect of Remdesivir on hospitalized COVID-19 patients’ outcomes.

Material and methods

This study was an open-label, single-armed, clinical trial on hospitalized patients diagnosed with COVID-19 who had progressive respiratory symptoms despite receiving standard care. All patients received Remdesivir and their characteristics, outcomes, time of treatment initiation, and respiratory support stages during hospitalization were registered and followed up for 14 days.

Results

145 patients with the mean age of 52.89 ± 1.12 years enrolled in this study, 38 (26.2%) died at the end of 14 days period. The mean time interval from the onset of the symptoms to antiviral treatment was 10.63±0.56 days. Thirty deceased patients (78.9%) were men, showing 2.8 times higher mortality chance compared to women (OR adj =2.77; 95%CI=1.08-7.09). The type of respiratory support on the first day of treatment initiation showed a significantly lower mortality chance in patients receiving O 2 only than those who needed non-invasive and/or mechanical ventilation (OR adj =3.91; 95%CI=1.64-9.32). The start time (early vs late administration) and duration (less or more than 7 days) of antiviral treatment had no statistically significant association with mortality or ventilation escalation among the patients (p-value > 0.05).

Conclusion

In this study, we showed that Remdesivir probably is not effective on the outcome of hospitalized COVID-19 patients.

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  1. ScreenIT

    SciScore for 10.1101/2021.08.13.21261992: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: Informed consent was obtained from each patient or his/her guardian beforehand, and the clinical trial protocol was approved by local ethics committee (code: IR.AJUMS.REC.1399.407) and registered in the Iranian Registry of Clinical Trials (code: IRCT20200404046937N5).
    IRB: Informed consent was obtained from each patient or his/her guardian beforehand, and the clinical trial protocol was approved by local ethics committee (code: IR.AJUMS.REC.1399.407) and registered in the Iranian Registry of Clinical Trials (code: IRCT20200404046937N5).
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisNo sample-size calculation was performed.

    Table 2: Resources

    No key resources detected.

    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.08.13.21261992v1 on medRxiv