Peginterferon lambda for the treatment of outpatients with COVID-19: a phase 2, placebo-controlled randomised trial
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SciScore for 10.1101/2020.11.09.20228098: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: In line with institutional COVID-19 restrictions, all individuals provided witnessed verbal informed consent. Randomization Study Design: This was a randomized, double-blind, placebo-controlled study, involving six institutions in Toronto, Canada, evaluating treatment with a single 180 μg subcutaneous injection of peginterferon-lambda or placebo in outpatients with COVID-19. Blinding Temperature monitoring and assessments of adverse events (AEs) were conducted remotely by study personnel blinded to study arm along with self-collected mid-turbinate (MT) swabs on Day 0, 1, 2, 3, 5, 7, 10 and 14. Power Analysis Statistical Analysis: Based on early COVID-19 … SciScore for 10.1101/2020.11.09.20228098: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: In line with institutional COVID-19 restrictions, all individuals provided witnessed verbal informed consent. Randomization Study Design: This was a randomized, double-blind, placebo-controlled study, involving six institutions in Toronto, Canada, evaluating treatment with a single 180 μg subcutaneous injection of peginterferon-lambda or placebo in outpatients with COVID-19. Blinding Temperature monitoring and assessments of adverse events (AEs) were conducted remotely by study personnel blinded to study arm along with self-collected mid-turbinate (MT) swabs on Day 0, 1, 2, 3, 5, 7, 10 and 14. Power Analysis Statistical Analysis: Based on early COVID-19 studies12, 13, we estimated 40% viral clearance by Day 7 in the placebo arm and 80% in the peginterferon-lambda arm, requiring 30 patients per arm, to achieve 80% power with alpha of 0.05, accounting for 10% dropout. Sex as a biological variable not detected. Table 2: Resources
Antibodies Sentences Resources Anti-SARS-CoV-2 IgG antibodies to S protein were measured on Day 0, 3, 7 and 14 (DiaSorin, Saluggia, Italy). DiaSorin, Saluggia, Italy).suggested: NoneSecondary outcomes included: time to undetectable SARS-CoV-2 RNA, quantitative change in SARS-CoV-2 RNA over time, anti-SARS-CoV-2 IgG antibody positivity, the incidence and severity (mild/moderate/severe) of AEs, and the proportion hospitalized by Day 14. anti-SARS-CoV-2 IgGsuggested: NoneSoftware and Algorithms Sentences Resources Medication was supplied by Eiger BioPharmaceuticals. Eiger BioPharmaceuticalssuggested: NoneResults 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: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04354259 Recruiting Interferon Lambda for Immediate Antiviral Therapy at Diagnos… 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.
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