Clearing the Fog: Is Hydroxychloroquine Effective in Reducing Coronavirus Disease-2019 Progression? A Randomized Controlled Trial
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SciScore for 10.1101/2020.07.30.20165365: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study design was approved by institutional ethical review committee (ERC).
Consent: The study population was comprised of patients from both genders with Mild confirmed COVID-19 after their written consent.Randomization This single Centre, parallel open label randomized controlled trial was carried out during 10th April to 31st May 2020 at department of Pulmonology, Pakistan Emirates Military Hospital (PEMH) over 500 patients from both genders between 18-80 years of age. Blinding not detected. Power Analysis Sample size was calculated using OPEN EPI with 5% level of Confidence and 80% power to detect a difference and enrolment ration 2:1 between … SciScore for 10.1101/2020.07.30.20165365: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement IRB: The study design was approved by institutional ethical review committee (ERC).
Consent: The study population was comprised of patients from both genders with Mild confirmed COVID-19 after their written consent.Randomization This single Centre, parallel open label randomized controlled trial was carried out during 10th April to 31st May 2020 at department of Pulmonology, Pakistan Emirates Military Hospital (PEMH) over 500 patients from both genders between 18-80 years of age. Blinding not detected. Power Analysis Sample size was calculated using OPEN EPI with 5% level of Confidence and 80% power to detect a difference and enrolment ration 2:1 between intervention and control group, at a two-sided significance level of α=0.05, of 7 days in the median time to clinical improvement between the two groups, assuming that the median time in the SOC group was 14 days and assuming 55% efficacy of HCQ in preventing disease progression and achieving viral clearance at day 7. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources The study population was comprised of patients from both genders with Mild confirmed COVID-19 after their written consent. Mildsuggested: (MILD, RRID:SCR_003335)Statistical interpretation of data was performed using Statistical Package for Social Sciences (SPSS) version 23. SPSSsuggested: (SPSS, RRID:SCR_002865)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:Nevertheless, there are certain limitations of our study as well. Firstly, the main subgroup in which study was done were males so the results cannot be generalized to both genders. Secondly, the study was done in mild cases and moderate/severe cases were not included so it cannot be determined whether HCQ is of any benefit in advanced COVID-19 or not. Thirdly, the patients were not followed up after discharge from the hospital hence, exact progression of disease could not be ascertained. Fourthly, we did not use quantitive RT-PCR to exactly determine the viral load which is a strong bias to affect viral clearance. Fifthly, PCR positivity at day 14 is of uncertain significance because it is now evident that after 10th day onset of illness, presence of non-replicable viral nucleic acid material only, are being picked up by the PCR18,19 and such patients are regarded as non-infective. Finally, even with best sampling techniques, sensitivity of RT-PCR for SARS-CoV-2 ranges between 34-80%20 so exact estimation of viral clearance will definitely remain under question. Despite the limitations, our study is first of its own kind in Pakistan which is reinforced by a larger sample size and relatively longer follow up time.
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04491994 Completed Clearing the Fog: Is Hydroxychloroquine Effective in Reducin… 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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