Post-exposure prophylaxis or pre-emptive therapy for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2): study protocol for a pragmatic randomized-controlled trial
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SciScore for 10.1101/2020.05.01.20087999: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: During recruitment and follow-up, most participants will be at home in self isolation or quarantine; screening, informed consent, randomization and data collection will occur online through the Research Electronic Data Capture (REDCap), a secure web-based platform. Randomization During recruitment and follow-up, most participants will be at home in self isolation or quarantine; screening, informed consent, randomization and data collection will occur online through the Research Electronic Data Capture (REDCap), a secure web-based platform. Blinding Randomization sequence generation, allocation concealment, and blinding: Participants will be randomized via … SciScore for 10.1101/2020.05.01.20087999: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: During recruitment and follow-up, most participants will be at home in self isolation or quarantine; screening, informed consent, randomization and data collection will occur online through the Research Electronic Data Capture (REDCap), a secure web-based platform. Randomization During recruitment and follow-up, most participants will be at home in self isolation or quarantine; screening, informed consent, randomization and data collection will occur online through the Research Electronic Data Capture (REDCap), a secure web-based platform. Blinding Randomization sequence generation, allocation concealment, and blinding: Participants will be randomized via computer-generated permuted block randomization and stratified into the PEP trial (for asymptomatic participants) or the PET trial (for symptomatic participants). Power Analysis With 1:1 randomization and 1464 total participants, the PET trial has 90% power to detect a log odds ratio of 0.70. Sex as a biological variable In the US, the FDA has approved the inclusion of pregnant and breastfeeding women citing hydroxychloroquine safety data in pregnant patients with autoimmune conditions including systemic lupus erythematosus and malaria.34 Interventions: Participants will be randomized 1:1 to receive hydroxychloroquine or placebo. Table 2: Resources
Software and Algorithms Sentences Resources Data collection methods and data management: All data collection, including baseline demographics, clinical and epidemiological characteristics, study medicine tolerability, adherence, and outcomes will be recorded online through self-report captured in internet-based questionnaires (administered in REDCap). 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 NCT04308668 Completed Post-exposure Prophylaxis / Preemptive Therapy for SARS-Coro… 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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