A Randomized Clinical Trial of the Efficacy and Safety of Interferon β-1a in Treatment of Severe COVID-19

  1. Effat Davoudi-Monfared
  2. Hamid Rahmani
  3. Hossein Khalili
  4. Mahboubeh Hajiabdolbaghi
  5. Mohamadreza Salehi
  6. Ladan Abbasian
  7. Hossein Kazemzadeh
  8. Mir Saeed Yekaninejad

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Abstract

To the best of our knowledge, there is no published study on the use of interferon β-1a (IFN β-1a) in the treatment of severe COVID-19. In this randomized clinical trial, the efficacy and safety of IFN β-1a were evaluated in patients with severe COVID-19. Forty-two patients in the interferon group received IFN β-1a in addition to the national protocol medications (hydroxychloroquine plus lopinavir-ritonavir or atazanavir-ritonavir). Each 44-μg/ml (12 million IU/ml) dose of interferon β-1a was subcutaneously injected three times weekly for two consecutive weeks.

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  1. Version published to 10.1128/aac.01061-20
  2. ScreenIT

    SciScore for 10.1101/2020.05.28.20116467: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: The protocol of study was explained for all patients or their caregivers and informed consent was obtained from each participant.
    RandomizationStudy design: This open-label randomized clinical trial was conducted to assess efficacy and safety of IFN-β-1a in treatment of adult (aged ≥ 18 years old) patients diagnosed with COVID-19.
    Blindingnot detected.
    Power AnalysisSample size was estimated for medium effect size with α = 0.05 and power = 0.85.
    Sex as a biological variablePatients with each of the following characteristics were excluded: allergy to IFNs, receiving IFNs for any other reasons, previous suicide attempts, alanine amino transferase (ALT)> 5× the upper limit of the normal range and pregnant women.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    SPSS software (version 21.0) was used for statistical analyses.
    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: We detected the following sentences addressing limitations in the study:
    This study had some limitations. Both patients in general, intermediate and intensive care units wards were recruited. Most of the general wards in fact were intermediate wards, but the accurate classification was not possible due to special and emergent conditions. Due to restrictions in each pandemic event and low experiences, diagnosis of COVID-19 was according to either positive RT-PCR or signs/symptoms plus imaging findings highly suggestive for the disease. Also considering the follow-up imaging and RT-PCR were not feasible.

    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.

  3. Version published to 10.1101/2020.05.28.20116467 on medRxiv