Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase 2, open-label, randomised controlled trial

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  1. Ariel Berlinski

    Review 2: "Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial"

    This study suggests that budesonide, a corticosteroid used for COPD and asthma treatment, reduces the likelihood of urgent care, ED visit, or hospitalization in patients with early COVID-19; both reviewers found the study findings to be reasonable and potentially reliable.

  2. Ying-Rong Du, Hai-yan Fu

    Review 1: "Inhaled budesonide in the treatment of early COVID-19 illness: a randomised controlled trial"

    This study suggests that budesonide, a corticosteroid used for COPD and asthma treatment, reduces the likelihood of urgent care, ED visit, or hospitalization in patients with early COVID-19; both reviewers found the study findings to be reasonable and potentially reliable.

  3. This Zenodo record is a permanently preserved version of a PREreview. You can view the complete PREreview at https://prereview.org/reviews/4663312.

    By Yash S. Huilgol[1] UC Berkeley-UCSF Joint Medical Program, Berkeley, CA, USA[2] Editorial Office, Rapid Reviews: COVID-19

     

    Main Claim & Relevance:

    In this preprint by Ramakrishnan et al [1], inhaled budesonide, a corticosteroid used for long-term COPD and asthma treatment, reducing the likelihood of urgent care, ED visit, or hospitalization among patients with early COVID-19 illness. This amounted to a relative risk reduction of 90%, or a difference in proportions of 13.1% between the budesonide and standard of care arms.

    Are the findings strong, reliable, potentially informative, not informative, or misleading? Why?

    The findings are reliable, though the findings need to be …

  4. SciScore for 10.1101/2021.02.04.21251134: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Participants were seen at their homes at randomisation (day 0), day 7 and day 14 by a trained respiratory research nurse to obtain written informed consent, provide inhalers and to obtain nasopharyngeal swabs for SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) testing (see supplementary methods for further details).
    IRB: Institutional Review: The trial was sponsored by the University of Oxford, and was approved by the Fulham London Research Ethics Committee (20/HRA/2531) and the National Health Research Authority.
    RandomizationParticipants are randomly allocated to UC or BUD, stratified for participant age,(≤40 years/ >40 years) …