Hydroxychloroquine in mild-to-moderate coronavirus disease 2019: a placebo-controlled double blind trial
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SciScore for 10.1101/2020.10.19.20214940: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Written informed consent was obtained from each patient or from the patient’s legal representative if the patient was unable to provide consent. Randomization Trial design: HYCOVID was a double-blind, placebo-controlled, randomized trial conducted from April 2 to May 21, 2020 in 48 hospitals in France and the Principality of Monaco. Blinding not detected. Power Analysis A headcount of 615 patients per group allows demonstrating, under a bilateral hypothesis, an absolute difference of 6% between the two groups (relative difference of 30%), with an alpha risk of 5% and a power of 80%. Sex as a biological variable Patients: Men and non-pregnant women aged ≥18 … SciScore for 10.1101/2020.10.19.20214940: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Consent: Written informed consent was obtained from each patient or from the patient’s legal representative if the patient was unable to provide consent. Randomization Trial design: HYCOVID was a double-blind, placebo-controlled, randomized trial conducted from April 2 to May 21, 2020 in 48 hospitals in France and the Principality of Monaco. Blinding not detected. Power Analysis A headcount of 615 patients per group allows demonstrating, under a bilateral hypothesis, an absolute difference of 6% between the two groups (relative difference of 30%), with an alpha risk of 5% and a power of 80%. Sex as a biological variable Patients: Men and non-pregnant women aged ≥18 years with a diagnosis of COVID-19 confirmed by positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) on a nasopharyngeal swab within 2 days were assessed for eligibility. 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:Conversely, the lack of power is the main limitation of our trial. Indeed, the study was prematurely stopped after the inclusion of 19% of the planned number of patients due to the slowdown of the epidemic and following the publication of a subsequently retracted study raising concerns over hydroxychloroquine cardiovascular toxicity. We did not identify any safety concerns related to hydroxychloroquine use. However, we excluded patients with conditions that put them at risk of increased hydroxychloroquine toxicity, such as hypokalemia, prolonged corrected QT interval, or concomitant treatment with an increased risk of torsade de pointes. Of note, hypokalemia has been identified as a frequent complication of COVID-19 [22], and its presence is associated with disease severity. The exclusion of hypokalemic patients may have contributed to the low rate of adverse course that we observed. The frequency of the primary endpoint, a composite of death or the need for invasive mechanical ventilation at Day 14, was much lower than expected (6.9% versus 20%). This discrepancy may arise from several factors. First, recent data have demonstrated mortality rates lower than those observed in the early phases of the epidemic in Wuhan, on which we based the estimate of the number of needed patients [20, 21]. Second, 15% of the patients included in this study have been treated with corticosteroids during the disease course, and it has been recently demonstrated that dexamethasone decreases mort...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04325893 Terminated Hydroxychloroquine Versus Placebo in COVID-19 Patients at Ri… 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 10.1101/2020.10.19.20214940: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Written informed consent was obtained from each patient or from the patient’s legal representative if the patient was unable to provide consent. Randomization Eligible patients were randomized in a 1:1 ratio to receive either 800mg hydroxychloroquine on Day 0 followed by 400mg per day for 8 days or a placebo. Blinding not detected. Power Analysis A headcount of 615 patients per group allows demonstrating, under a bilateral hypothesis, an absolute difference of 6% between the two groups (relative difference of 30%), with an alpha risk of 5% and a power of 80%. Sex as a biological variable Patients Men and non-pregnant women aged ≥18 years with a diagnosis of COVID-19 … SciScore for 10.1101/2020.10.19.20214940: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement Written informed consent was obtained from each patient or from the patient’s legal representative if the patient was unable to provide consent. Randomization Eligible patients were randomized in a 1:1 ratio to receive either 800mg hydroxychloroquine on Day 0 followed by 400mg per day for 8 days or a placebo. Blinding not detected. Power Analysis A headcount of 615 patients per group allows demonstrating, under a bilateral hypothesis, an absolute difference of 6% between the two groups (relative difference of 30%), with an alpha risk of 5% and a power of 80%. Sex as a biological variable Patients Men and non-pregnant women aged ≥18 years with a diagnosis of COVID-19 confirmed by positive SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) on a nasopharyngeal swab within 2 days were assessed for eligibility. 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:
Conversely, the lack of power is the main limitation of our trial. Indeed, the study was prematurely stopped after the inclusion of 19% of the planned number of patients due to the slowdown of the epidemic and following the publication of a subsequently retracted study raising concerns over hydroxychloroquine cardiovascular toxicity. We did not identify any safety concerns related to hydroxychloroquine use. However, we excluded patients with conditions that put them at risk of increased hydroxychloroquine toxicity, such as hypokalemia, prolonged corrected QT interval, or concomitant treatment with an increased risk of torsade de pointes. Of note, hypokalemia has been identified as a frequent complication of COVID19 [22], and its presence is associated with disease severity. The exclusion of hypokalemic patients may have contributed to the low rate of adverse course that we observed. The frequency of the primary endpoint, a composite of death or the need for invasive mechanical ventilation at Day 14, was much lower than expected (6.9% versus 20%). This discrepancy may arise from several factors. First, recent data have demonstrated mortality rates lower than those observed in the early phases of the epidemic in Wuhan, on which we based the estimate of the number of needed patients [20, 21]. Second, 15% of the patients included in this study have been treated with corticosteroids during the disease course, and it has been recently demonstrated that dexamethasone decreases morta...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04325893 Terminated Hydroxychloroquine Versus Placebo in COVID-19 Patients at Ri... 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.
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 checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.
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