Peer Review History
Original SubmissionAugust 27, 2020 |
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PONE-D-20-26952 Lack of protective effect of chloroquine derivatives on COVID-19 disease in a Spanish sample of chronically treated patients. PLOS ONE Dear Dr. Fibla, Thank you for submitting your manuscript to PLOS ONE. After initial evaluation, we feel that authors shall address this following comment from the editor prior to an external review. This is a very valuable and interesting manuscript that attempts to address the most urgent and heavily debated question, e.g. whether chloroquine is effective on COVID-19 or not. One major concern is the untreatment group which should be patients with autoimmune diseases without receiving chloroquine treatment rather than general population. Are patients with autoimmune diseases more vulnerable to be infected as compared with general population? Therefore, we invite you to submit a revised version of the manuscript that addresses this point. Please submit your revised manuscript by Oct 19 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Wenbin Tan Academic Editor PLOS ONE Journal requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 2. Please include additional information regarding the survey used in the study and ensure that you have provided sufficient details that others could replicate the analyses. For instance, if you developed the survey as part of this study and it is not under a copyright more restrictive than CC-BY, please include a copy, in both the original language and English, as Supporting Information. In addition, please indicate whether the survey was validated. 3. We note that you have indicated that data from this study are available upon request. PLOS only allows data to be available upon request if there are legal or ethical restrictions on sharing data publicly. For information on unacceptable data access restrictions, please see http://journals.plos.org/plosone/s/data-availability#loc-unacceptable-data-access-restrictions. In your revised cover letter, please address the following prompts: a) If there are ethical or legal restrictions on sharing a de-identified data set, please explain them in detail (e.g., data contain potentially identifying or sensitive patient information) and who has imposed them (e.g., an ethics committee). Please also provide contact information for a data access committee, ethics committee, or other institutional body to which data requests may be sent. b) If there are no restrictions, please upload the minimal anonymized data set necessary to replicate your study findings as either Supporting Information files or to a stable, public repository and provide us with the relevant URLs, DOIs, or accession numbers. Please see http://www.bmj.com/content/340/bmj.c181.long for guidelines on how to de-identify and prepare clinical data for publication. For a list of acceptable repositories, please see http://journals.plos.org/plosone/s/data-availability#loc-recommended-repositories. We will update your Data Availability statement on your behalf to reflect the information you provide. |
Revision 1 |
PONE-D-20-26952R1 Lack of protective effect of chloroquine derivatives on COVID-19 disease in a Spanish sample of chronically treated patients. PLOS ONE Dear Dr. Fibla, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Dec 05 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript:
If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Wenbin Tan Academic Editor PLOS ONE Review Comments to the Author Reviewer #1: The article by Laplana et al. is a survey-based research article aimed to address the potential effectiveness of chloroquine and its derivatives to prevent SARS-CoV-2 infection among patients regularly taking these drugs for treatment of their autoimmune diseases. Authors found that difference in mean prevalence of declared COVID-19 status was not statistically significant between the treated group (5.3%) and the untreated-matched group (3.4%). Minor Comments Line 64: Authors should quote also: PMID: 32693652 and PMID: 32311322 Apart from being based on surveys, study has other limitations that should be acknowledged, such as lack of information about chloroquine/HCQ dose. Moreover, “untreated” cases also included individuals beginning acute treatment during January-March 2020. Lines 178-184: conclusions should be rephrased, pointing out that this study may suggest lack of efficacy of chloroquine and its derivatives as a prophylactic strategy against COVID-19 in patients with autoimmune diseases or other chronic conditions which require CQ/HCQ treatment and potentially increase the risk for SARS-CoV-2 infection per se. Therefore, efficacy of chloroquine and its derivatives in preventing SARS-CoV-2 infection will be determined by upcoming clinical trials. Reviewer #2: This paper cumulates all the conditions that make the understanding, around hydroxychloroquine and COVID-19, completely incomprehensible. Firstly, these are not people diagnosed with COVID-19 but people interviewed by telephone. At present, recent work carried out, determining the predictive value of the clinical diagnosis or diagnosis considered by people appears to be less than 50%. Based on these elements, it is impossible to make statistics, especially with such low numbers. In practice, COVID-19 is a disease for which a biological diagnosis is made, not a diagnosis by telephone. Furthermore, the number of people interviewed is extremely low, and finally, there is no control group, as has been done in other, much more convincing studies in the literature, of patients with a comparable pathology and taking another treatment than hydroxychloroquine. In practice, this paper is just a paper of opportunism, which does not contribute to knowledge, and is just being swept away by the flood of COVID-19 and hydroxychlroquine delirium. Reviewer #3: This manuscript describes an interesting study on lack of protective effect of chloroquine derivatives on COVID-19 disease among sample of chronically treated patients in Spain. The manuscript attempts to address an important global public health issue – COVID-19 disease. Understanding treatments that are effective in managing the disease is of paramount importance to policymakers and program managers in addressing this global public health issue. Presently, there is paucity of data on the subject so this manuscript if published could provide some information on the subject. However, my only concern is wrong analysis conducted and the case-control design used in ruling out the protective effect of chloroquine derivatives on COVID-19 disease. See more details below: Introduction: a) The authors provided enough background to the study. Methods: b) The methods employed by the authors in the analysis and presentation of the data appears problematic (see Table 1). The authors appeared to have analysed and presented the results for the treated group against the demographic characteristics separately and also for the untreated group separately. This is inappropriate because the analyses and the presentation of the results must be done across the treated and the untreated groups to be able to identify any protective effect of the intervention in the treated group as against the untreated group. This is a major flaw in this paper. This must be corrected, and more details provided in the methods section about the analysis plans. c) Also, randomised studies design could have provided a better alternative to case control design. Thus, absence of randomization could potentially lead to unreliable parameter estimates and its associated misleading conclusion. However, the authors raised genuine concerns in their first round of revision as to why they have used the case control as oppose to other relatively better designs. This is a limitation for the study. d) The selection of controls (untreated) was also problematic, but the authors provided justification for this in their first round of revision which I consider to be satisfactory. e) Furthermore, the analysis did not adjust for potential confounding among demographic characteristics under consideration in this study because only bivariate analysis via Fisher’s Exact test was conducted. Multivariable analysis is needed to address this concern. Results: f) The results appear not to address the research question and the hypothesis postulated. Re-analysis is required. For example, if age range is not statistically significant for the treated group and also not significant for the untreated group, this could not mean that chloroquine or derivatives has no protective effect on COVID-19 disease or vice versa. g) Also, descriptively, you might observe some differences in percentages in COVID-19 prevalence between treated and untreated group BUT statistically, that may not be important (i.e. statistical significance) or vice versa. Hence decision to conclude on any protective effect of chloroquine derivatives on COVID-19 disease should be based on statistical significance based on sound hypothesis testing. Discussion and conclusion: h) The issues raised in the methods and the result sections should be addressed to enable the reviewer do sound evaluation of the discussion and conclusion sections. |
Revision 2 |
Lack of protective effect of chloroquine derivatives on COVID-19 disease in a Spanish sample of chronically treated patients. PONE-D-20-26952R2 Dear Dr. Fibla, We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Wenbin Tan Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: Reviewer's Responses to Questions Comments to the Author Reviewer #1: All comments have been addressed |
Formally Accepted |
PONE-D-20-26952R2 Lack of protective effect of chloroquine derivatives on COVID-19 disease in a Spanish sample of chronically treated patients. Dear Dr. Fibla: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr. Wenbin Tan Academic Editor PLOS ONE |
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