Efficacy and safety of a novel antiviral preparation in ICU-admitted patients with COVID-19: a phase III randomized controlled trial

  1. Hossein Faramarzi
  2. Amirhossein Sahebkar
  3. Ahmad Hosseinpour
  4. Vahid Khaloo
  5. Parisa Chamanpara
  6. Mohammad Reza Heydari
  7. Sajad Najafi
  8. Fatemeh Fotoohi Khankahdany
  9. Ahmad Movahedpour

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Abstract

Introduction

Despite an increasing number of studies, there is as yet no efficient antiviral treatment developed for the disease. In this clinical trial, we examined the efficacy of a novel herbal antiviral preparation comprising Zataria multiflora Boiss, Glycyrrhiza glabra, Cinnamomum Vermont, Allium sativuml , and Syzygium aromaticum in critically ill patients with COVID-19 patients.

Methods

A total number of 120 ICU-admitted patients requiring pulmonary support with a diagnosis of COVID-19 pneumonia were recruited to the trial. Participants were equally randomized to receive either the novel antiviral preparation sublingually, for up to two consecutive weeks or till discharge, or normal saline as the matching placebo. Clinical and laboratory parameters as well as survival rates were compared between the two groups at the study end.

Results

The cumulative incidence of death throughout the study period was 8.33% in the medication group and 60% in the placebo group (risk ratio: 0.14; 95% confidence interval [CI], 0.05 to 0.32; P<0.001). Survival rates were significantly higher in the treatment group. Additionally, on day 7, several laboratory factors including white blood cells (WBCs) count, C-reactive protein (CRP), and SpO 2 were improved in patients treated with the novel antiviral preparation compared with the placebo group.

Conclusion

The novel antiviral preparation tested in this trial significantly improved the survival rate and reduced mortality in critically ill patients with COVID-19. Thus, this preparation might be suggested as a potentially promising COVID-19 treatment.

Funded by Shimi Teb Salamat Co., Shiraz, Iran, and registered on the Iranian registry of clinical trials (registration No. IRCT20200509047373N2).

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    SciScore for 10.1101/2021.11.20.21266229: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: ICU-admitted patients were included in the trial with several eligibility criteria including having confirmed diagnosis of COVID-19, high pulmonary involvement in imaging, requirement to respiratory support but not mechanical ventilation (however, they may require mechanical ventilation during trial), aged 15 years or older, filled informed consent, and not participated in other clinical trials.
    IRB: The research was approved by the Ethics Committee of the Shiraz University of Medical Sciences (registration No. IR.SUMS.REC.1399.1367).
    Sex as a biological variablePregnant women and patients younger than 15 years were excluded from the study.
    RandomizationTrial Design and Participants: COVID-19 patients hospitalized in an ICU department of Shiraz University of Medical Sciences, Shiraz, Iran, were enrolled in a randomized, double-blind, placebo-controlled phase III clinical trial conducted during March 21-June 19,2021.
    BlindingSubjects in the placebo group were given a matching placebo containing normal saline in the same packaging with similar appearance, volume, and dosing as the active compound to maintain blinding.
    Power AnalysisBy considering 90% power to detect a between-group difference and the alpha level of 5%, we estimated a sample of 120 patients (60 per group).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical Analysis: The retrieved data was exported to SPSS software, version 18.0 (SPSS Statistics).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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

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  2. Version published to 10.1101/2021.11.20.21266229v2 on medRxiv
  3. Version published to 10.1101/2021.11.20.21266229v1 on medRxiv