Effect of High vs Low Doses of Chloroquine Diphosphate as Adjunctive Therapy for Patients Hospitalized With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
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SciScore for 10.1101/2020.04.07.20056424: (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 timely approved by the Brazilian Committee of Ethics in Human Research (CONEP approval 3.929.646/2020).
Consent: They were given time to carefully read and then sign an informed consent form (ICF).Randomization 32 Study design and site: CloroCovid-19 was a parallel, double-blind, randomized, phase IIb clinical trial, which started on March 23rd, 2020, aiming to assess safety and efficacy of CQ in the treatment of hospitalized patients with severe respiratory syndrome secondary to SARS-CoV-2 infection (ClinicalTrials.gov, number NCT04323527). Blinding Placebo tablets also produced by Farmanguinhos were used in the latter in order to … SciScore for 10.1101/2020.04.07.20056424: (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 timely approved by the Brazilian Committee of Ethics in Human Research (CONEP approval 3.929.646/2020).
Consent: They were given time to carefully read and then sign an informed consent form (ICF).Randomization 32 Study design and site: CloroCovid-19 was a parallel, double-blind, randomized, phase IIb clinical trial, which started on March 23rd, 2020, aiming to assess safety and efficacy of CQ in the treatment of hospitalized patients with severe respiratory syndrome secondary to SARS-CoV-2 infection (ClinicalTrials.gov, number NCT04323527). Blinding Placebo tablets also produced by Farmanguinhos were used in the latter in order to standardize treatment and blinding of research team and participants. Power Analysis Thus, considering a test of differences in proportions between 2 groups of the same size, 80% power and 5% alpha, 394 participants were needed (197 per group). Sex as a biological variable not detected. 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:Therefore, one limitation for the conclusions of the study on lethality per arm is that high CQ dosage arm presented more patients prone to cardiac complications, with or without CQ. In any case, the use of CQ in elderlies with heart disease should be made with caution. Lethality in critically-ill patients seemed to be even higher than similar patients in Italy. That could reflect the quality of ICU in both countries or the possible lack of or deleterious effect of CQ in such patients with COVID-19. The occurrence of myocarditis in our sample together with the confirmed QTc prolongation, warrants caution in relation to this drug’s safety, particularly considering the eventual increase in fatal arrythmias, such as ventricular tachycardia. This study had some strengths, as it was: (1) double-blinded; (2) performed in a public hospital, which will represent most of the cases in countries like Brazil; (3) compliant with good clinical practices, with a vigilant and highly involved DSMB; (4) an assessment of two dosing schemes of CQ for the first time in COVID-19 patients. Major limitations however included: (1) one single center; (2) not using a placebo control group as the use of placebo in Brazil in severe cases of COVID-19 infections is not considered ethically acceptable by national regulatory health agencies, especially due to the compassionate use of CQ – and because early reports seem to indicate its effectiveness in vitro and in vivo. In conclusion, high CQ dosage scheme (...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04323527 Completed Chloroquine Diphosphate for the Treatment of Severe Acute Re… NCT04342650 Completed Chloroquine Diphosphate in the Prevention of SARS in Covid-1… 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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SciScore for 10.1101/2020.04.07.20056424: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The protocol was timely approved by the Brazilian Committee of Ethics in Human Research ( CONEP approval 3.929.646/2020) . Randomization This is the first double-blinded , randomized clinical trial addressing different dosages of CQ for the treatment of severe patients with COVID-19 in the absence of a control group using placebo . Blinding Placebo tablets also produced by Farmanguinhos were used in the latter in order to standardize treatment and blinding of research team and participants . Power Analysis Thus , considering a test of differences in proportions between 2 groups of the same size , 80 % power and 5 % alpha , 394 participants were needed ( … SciScore for 10.1101/2020.04.07.20056424: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The protocol was timely approved by the Brazilian Committee of Ethics in Human Research ( CONEP approval 3.929.646/2020) . Randomization This is the first double-blinded , randomized clinical trial addressing different dosages of CQ for the treatment of severe patients with COVID-19 in the absence of a control group using placebo . Blinding Placebo tablets also produced by Farmanguinhos were used in the latter in order to standardize treatment and blinding of research team and participants . Power Analysis Thus , considering a test of differences in proportions between 2 groups of the same size , 80 % power and 5 % alpha , 394 participants were needed ( 197 per group) . Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources We searched PubMed and also MedRxiv.org (pre-print server for health sciences, without peer review), without any language restrictions and including Chinese publications, for studies published between Dec 2019 and April 5, 2020, using the search terms ‘COVID-19, coronavirus, SARS-Cov-2’. PubMedsuggested: (PubMed, SCR_004846)This study was registered with ClinicalTrials . ClinicalTrialssuggested: (ClinicalTrials.gov, SCR_002309)Data were recorded on Medview and then transferred into an electronic database ( REDCap) , in tablet computers , at bedside in the wards , further validated by external trial monitoring staff . REDCapsuggested: (REDCap, SCR_003445)e Excelencia Severo Ochoa 2019-2023 Program (CEX2018-000806-S), and support from Generalitat de Catalunya through the CERCA Program. CERCA Programsuggested: NoneResults 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).
About SciScore
SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore is not a substitute for expert review. SciScore checks for the presence and correctness of RRIDs (research resource identifiers) in the manuscript, and detects sentences that appear to be missing RRIDs. SciScore also checks to make sure that rigor criteria are addressed by authors. It does this by detecting sentences that discuss criteria such as blinding or power analysis. SciScore does not guarantee that the rigor criteria that it detects are appropriate for the particular study. Instead it assists authors, editors, and reviewers by drawing attention to sections of the manuscript that contain or should contain various rigor criteria and key resources. For details on the results shown here, including references cited, please follow this link.
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