Treatment Response to Hydroxychloroquine and Antibiotics for mild to moderate COVID-19: a retrospective cohort study from South Korea
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Abstract
Objectives
To assess the efficacy of hydroxychloroquine on mild-moderate COVID-19 patients in South Korea.
Methods
A retrospective cohort study of the 358 laboratory-confirmed SARS-CoV-2 (COVID-19) patients was conducted. 226 patients met inclusion criteria for analysis. Propensity score matching (PSM) and Cox regression method were utilized to control and adjust for confounding factors. Mild to moderate COVID-19 patients were managed with hydroxychloroquine (HQ) plus antibiotics (n = 31) or conservative treatment (n = 195).
Results
Kaplan-Meier curves drawn using propensity score-matched data revealed no differences between the length of time to viral clearance and duration of hospital stay between the two treatment arms (p=0.18, p=0.088). Multivariable Cox regression analysis similarly showed that time to viral clearance(Hazard ratio (HR) 0.97, [95%-confidence interval (CI): 0.57-1.67]) and symptom duration(HR 1.05, [95%-CI: 0.62-1.78]) were not different between groups. No severe adverse event or death was observed in either group.
Conclusions
HQ with antibiotics was not associated with better clinical outcomes in terms of time to viral clearance, length of hospital stay, and duration of symptoms compared to conservative treatment alone. Large prospective randomized trials are necessary for definitive conclusions.
Article activity feed
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SciScore for 10.1101/2020.07.04.20146548: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were conducted using IBM SPSS, version 21.0 (SPSS Inc), or R software, version 3.6.0 (R Foundation for Statistical Computing). 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:Our study has several limitations. …
SciScore for 10.1101/2020.07.04.20146548: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
Software and Algorithms Sentences Resources All analyses were conducted using IBM SPSS, version 21.0 (SPSS Inc), or R software, version 3.6.0 (R Foundation for Statistical Computing). 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:Our study has several limitations. Although we attempted to control for known confounders by using propensity score matching and multivariable adjustment, there is still a risk of the presence of uncontrolled, unknown confounding factors and bias due to the retrospective study design. Additionally, the small size of the cohort limited the number of variables that were included in the propensity score model; we have thus incorporated a list of the most crucial prognostic and demographic factors in our model (27). Second, there were numerous asymptomatic patients, and as a result the time from symptom onset to admission was not evaluated in our study. However, we obtained detailed information on the length of delay from the date of diagnosis to treatment initiation, which provides is an objective measure of treatment timing. Third, QT prolongation or retinopathy, the known adverse effects of hydroxychloroquine(28, 29) were not actively measured in our study; while this must be kept into account as in any patient receiving hydroxychloroquine, no serious adverse reactions including cardiac toxicity or retinopathy were observed in our study population. Fourth, the baseline characteristics of the HQ plus antibiotics treatment group and the conservative care group is heterogenous (Table 1). The conservative treatment group was composed of slightly milder patients. However, such differences in baseline has was balanced after propensity score matching. Lastly, few patients in HQ plus ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
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 10.1101/2020.07.04.20146548: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The ethics committee of Pusan National University Yangsan Hospital approved this study and granted a waiver of informed consent from study participants . Randomization Large prospective randomized trials are necessary for definitive conclusions . Blinding not detected. Power Analysis not detected. Sex as a biological variable The mean age was 35.26 years ( standard deviation ( SD ) 14.22 ) and 43.48 ( SD 15.50 ) in the standard supportive therapy group and the HQ group , respectively . 117 ( 60.0 % ) were female in standard supportive therapy group , and 26 ( 83.9 % ) were female in the HQ group . Table 2: Resources
Software and Algorithms Sentences Resour… SciScore for 10.1101/2020.07.04.20146548: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement The ethics committee of Pusan National University Yangsan Hospital approved this study and granted a waiver of informed consent from study participants . Randomization Large prospective randomized trials are necessary for definitive conclusions . Blinding not detected. Power Analysis not detected. Sex as a biological variable The mean age was 35.26 years ( standard deviation ( SD ) 14.22 ) and 43.48 ( SD 15.50 ) in the standard supportive therapy group and the HQ group , respectively . 117 ( 60.0 % ) were female in standard supportive therapy group , and 26 ( 83.9 % ) were female in the HQ group . Table 2: Resources
Software and Algorithms Sentences Resources All analyses were conducted using IBM SPSS , version 21.0 ( SPSS Inc) , or R software , version 3.6.0 ( R Foundation for Statistical Computing) . SPSSsuggested: (SPSS, SCR_002865)Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:
- Our study has several limitations.
- Although we attempted to control for known confounders by using propensity score matching and multivariable adjustment, there is still a risk of the presence of uncontrolled, unknown confounding factors and bias due to the retrospective study design.
- Additionally, the small size of the cohort limited the number of variables that were included in the propensity score model; we have thus incorporated a list of the most crucial prognostic and demographic factors in our model
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).
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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