Randomised controlled trial of intravenous nafamostat mesylate in COVID pneumonitis: Phase 1b/2a experimental study to investigate safety, Pharmacokinetics and Pharmacodynamics

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1. Version published to 10.1016/j.ebiom.2022.103856

   Feb 1, 2022
2. 

   ScreenIT

   Oct 10, 2021

   SciScore for 10.1101/2021.10.06.21264648: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: Written informed consent was provided prior to any trial procedures being performed.
   Sex as a biological variable	not detected.
   Randomization	Trial design and participants: The DEFINE trial is a platform, multicentre, randomised controlled open label trial.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   This trial has been registered on ISRCTN (https://www.isrctn.com/) ISRCTN14212905, and Clinicaltrials.gov (https://www.clinicaltrials.gov/) NCT04473053.	https://www.isrctn.com/ suggested: (ISRCTN Registry, RRID:SCR_006087)
   All statistical models were fitted using SAS software (SAS Institute Inc.	SAS Institute suggested: (Statistical …

   SciScore for 10.1101/2021.10.06.21264648: (What is this?)

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

   Table 1: Rigor

   Ethics	Consent: Written informed consent was provided prior to any trial procedures being performed.
   Sex as a biological variable	not detected.
   Randomization	Trial design and participants: The DEFINE trial is a platform, multicentre, randomised controlled open label trial.
   Blinding	not detected.
   Power Analysis	not detected.

   Table 2: Resources

   Software and Algorithms
   Sentences	Resources
   This trial has been registered on ISRCTN (https://www.isrctn.com/) ISRCTN14212905, and Clinicaltrials.gov (https://www.clinicaltrials.gov/) NCT04473053.	https://www.isrctn.com/ suggested: (ISRCTN Registry, RRID:SCR_006087)
   All statistical models were fitted using SAS software (SAS Institute Inc.	SAS Institute suggested: (Statistical Analysis System, RRID:SCR_008567)
   The analyses were performed using two-sided tests and the GraphPad Prism 8 program.	GraphPad Prism suggested: (GraphPad Prism, RRID:SCR_002798)

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   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).

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   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.

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   Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
   

   Identifier	Status	Title
   NCT04473053	Active, not recruiting	DEFINE - Evaluating Therapies for COVID-19
   ISRCTN14212905	NA	NA

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   Results from Barzooka: We did not find any issues relating to the usage of bar graphs.

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   Results from JetFighter: We did not find any issues relating to colormaps.

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   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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   Results from scite Reference Check: We found no unreliable references.

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   Read the original source
3. 

   Version published to 10.1101/2021.10.06.21264648v1 on medRxiv

   Oct 7, 2021