Colchicine for community-treated patients with COVID-19 (COLCORONA): a phase 3, randomised, double-blinded, adaptive, placebo-controlled, multicentre trial
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SciScore for 10.1101/2021.01.26.21250494: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The protocol was approved by the institutional review board at all centers involved in the 6 countries that participated in the trial (Supplementary Appendix).
Consent: Written informed consent was obtained electronically or on paper from all patients before enrollment following a telemedicine or in-person visit, respectively.Randomization TRIAL DESIGN: COLCORONA was a randomized, double-blind, placebo-controlled, investigator-initiated trial comparing colchicine (0.5 mg twice daily for the first 3 days and then once daily for 27 days thereafter) with placebo in a 1:1 ratio. Blinding not detected. Power Analysis STATISTICAL ANALYSES: It was estimated that a … SciScore for 10.1101/2021.01.26.21250494: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The protocol was approved by the institutional review board at all centers involved in the 6 countries that participated in the trial (Supplementary Appendix).
Consent: Written informed consent was obtained electronically or on paper from all patients before enrollment following a telemedicine or in-person visit, respectively.Randomization TRIAL DESIGN: COLCORONA was a randomized, double-blind, placebo-controlled, investigator-initiated trial comparing colchicine (0.5 mg twice daily for the first 3 days and then once daily for 27 days thereafter) with placebo in a 1:1 ratio. Blinding not detected. Power Analysis STATISTICAL ANALYSES: It was estimated that a sample size of approximately 6000 randomized patients with 3000 patients in each treatment group would be required to detect a 25% relative risk reduction with colchicine with a power of 80% given a primary endpoint event rate of 7% in the placebo group and a two-sided test at the 0.05 significance level. Sex as a biological variable 15 Women were either not of childbearing potential or practicing adequate contraception. 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:Our trial has certain limitations. The study was stopped when 75% of the planned patients were recruited and had completed the 30-day follow-up. In addition to the logistical issues faced in the current challenging context, the perceived need to disseminate the study results rapidly in view of the current state of the pandemic largely contributed to our decision. The duration of follow-up was relatively short at approximately 30 days. The evolution of persistent COVID-19 symptoms and the effects of longer-term treatment with colchicine were not evaluated. The benefit of a shorter course of colchicine therapy for less than 30 days is also not entirely known, although the results of a small open-label study showed benefits of treatment administered for up to 3 weeks.19 Finally, our results apply to patients who have a proven diagnosis of COVID-19, are at risk of clinical complications and are not hospitalized at the time of treatment initiation. In conclusion, among non-hospitalized patients with confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospitalization than placebo.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04322682 Completed Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) 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 scite Reference Check: We found no unreliable references.
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