Pragmatic, open-label, single-center, randomized, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus in patients with severe pneumonia secondary to COVID-19: The TACROVID trial protocol
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SciScore for 10.1101/2021.01.09.21249263: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The key data in the Monitoring Plan are those related to informed consent, primary outcome, mortality and safety data.
IACUC: The protocol and informed consent form (ICF) were approved by the BUH’s Ethical Committee for Drug Research (EC) and by the Spanish Agency for Drugs and Health Products (AEMPS) in March 2020, in accordance with current legislation, Royal Decree 1090/2015 of December 4 and European Regulation 536/2014 of April 16, regulating clinical trials with drugs.
IRB: The study received the ethics approval by the Research Ethics Committee of Bellvitge University Hospital (AC010/20).Randomization 2.1 Study design: TACROVID is a pragmatical, … SciScore for 10.1101/2021.01.09.21249263: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: The key data in the Monitoring Plan are those related to informed consent, primary outcome, mortality and safety data.
IACUC: The protocol and informed consent form (ICF) were approved by the BUH’s Ethical Committee for Drug Research (EC) and by the Spanish Agency for Drugs and Health Products (AEMPS) in March 2020, in accordance with current legislation, Royal Decree 1090/2015 of December 4 and European Regulation 536/2014 of April 16, regulating clinical trials with drugs.
IRB: The study received the ethics approval by the Research Ethics Committee of Bellvitge University Hospital (AC010/20).Randomization 2.1 Study design: TACROVID is a pragmatical, randomized (1:1), open-label, single-center, phase II clinical trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus SoC, versus SoC alone, in severe COVID-19 patients with lung injury and systemic hyperinflammatory syndrome. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources Specific procedures that are performed on each visit are detailed in Table 1 and the evaluation methods section. 2.7 Evaluation Methods: 2.8 Outcomes: 2.9 Statistical analysis: 2.10 Monitoring: An electronic case report form (eCRF) has been created using the RedCap computer platform. RedCapsuggested: (REDCap, RRID:SCR_003445)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: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04341038 Recruiting Clinical Trial to Evaluate Methylprednisolone Pulses and Tac… 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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