Efficacy of Remdesivir-Containing Therapy in Hospitalized COVID-19 Patients: A Prospective Clinical Experience

  1. Alessandro Russo
  2. Erica Binetti
  3. Cristian Borrazzo
  4. Elio Gentilini Cacciola
  5. Luigi Battistini
  6. Giancarlo Ceccarelli
  7. Claudio Maria Mastroianni
  8. Gabriella d’Ettorre

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Abstract

Objectives: Remdesivir is currently approved for the treatment of COVID-19. The recommendation for using remdesivir in patients with COVID-19 was based on the in vitro and in vivo activity of this drug against SARS-CoV-2. Methods: This was a prospective observational study conducted on a population of patients hospitalized for COVID-19. The primary endpoint of this study was the impact of remdesivir-containing therapy on 30-day mortality; the secondary endpoint was the impact of remdesivir-containing therapy on the need for high-flow oxygen therapy (HFNC), non-invasive ventilation (NIV), or mechanical ventilation. The data were analyzed after propensity score matching. Results: A total of 407 patients with SARS-CoV-2 pneumonia were consecutively enrolled. Out of these, 294 (72.2%) were treated with remdesivir and 113 (27.8%) were not. Overall, 61 patients (14.9%) were treated during hospitalization with HFNC, NIV, or mechanical ventilation, while 30-day mortality was observed in 21 patients (5.2%). Univariate analysis of patients treated with remdesivir or not showed no differences in 30-day mortality (4% vs. 6%, p = 0.411) in the two study groups. Cox regression analysis, after propensity score matching, showed that therapies, including remdesivir-containing therapy, were not statistically associated with 30-day survival or mortality. The Kaplan–Meier curves of 30-day survival in patients treated with remdesivir or not before (p = 0.24) and after (p = 0.88) propensity score matching showed no differences between the two study groups. Finally, patients treated with remdesivir or not showed the same need for HFNC/NIV or mechanical ventilation. Conclusions: This real-life experience of remdesivir use in hospitalized patients with COVID-19 was not associated with significant increases in rates of survival or reduced use of HFNC/NIV or mechanical ventilation compared with patients treated with other therapies not including remdesivir.

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  1. Version published to 10.3390/jcm10173784
  2. ScreenIT

    SciScore for 10.1101/2021.07.01.21259852: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: The patient’s informed consent was obtained.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.

    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: We detected the following sentences addressing limitations in the study:
    Conversely, data from Solidarity trial, conducted in 30 countries [11], showed no decrease of in-hospital mortality in patients treated with remdesivir, with the important limitation that other outcomes, clinical improvement and adverse events, were non carefully evaluated. Some important meta-analysis showed that COVID-19 patients receiving remdesivir had significantly higher rates of recovery and hospital discharge with lower rates of developing serious adverse events compared to patients receiving standard of care/placebo [12-13]. However, these analyses confirmed that no significant differences were observed about clinical improvement and rate of mortality during hospitalization. Specifically, mortality was the main outcome reported in all included studies, and none of the studies showed significant decrease of mortality also if they were not adequately powered for mortality outcome [12]. Wang et al. [14] reported the first double blinded, randomized, clinical trial in which were evaluated patients with an interval from symptoms onset to enrollment of 12 days or less. No differences in mortality were recorded in the 2 arms, also if authors highlighted a possible trend towards clinical benefit in remdesivir group. Of importance, a large number of patients in this study were treated also with steroids (65% of patients who received remdesivir and 68% of patients in placebo arm) which may have confounded the results and the conclusions. A strength of our study, with the limit...

    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

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  3. Version published to 10.1101/2021.07.01.21259852v1 on medRxiv