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Review 2: "Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: A multi-center observational study"

This observational study is potentially informative. It suggests an association between outpatient hydroxychloroquine use decreased hospitalization rate. However, both RR:C19 reviewers expressed concern about the study design, variable definitions, and generalizability.

Published onOct 22, 2020
Review 2: "Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: A multi-center observational study"
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key-enterThis Pub is a Review of
Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: A multi-center observational study
Description

Background: Hydroxychloroquine has not been associated with improved survival among hospitalized COVID-19 patients in the majority of observational studies and similarly was not identified as an effective prophylaxis following exposure in a prospective randomized trial. We aimed to explore the role of hydroxychloroquine therapy in mildly symptomatic patients diagnosed in the outpatient setting. Methods: We examined the association between outpatient hydroxychloroquine exposure and the subsequent progression of disease among mildly symptomatic non-hospitalized patients with documented SARS-CoV-2 infection. The primary outcome assessed was requirement of hospitalization. Data was obtained from a retrospective review of electronic health records within a New Jersey USA multi-hospital network. We compared outcomes in patients who received hydroxychloroquine with those who did not applying a multivariable logistic model with propensity matching. Results: Among 1274 outpatients with documented SARS-CoV-2 infection 7.6% were prescribed hydroxychloroquine. In a 1067 patient propensity matched cohort, 21.6% with outpatient exposure to hydroxychloroquine were hospitalized, and 31.4% without exposure were hospitalized. In the primary multivariable logistic regression analysis with propensity matching there was an association between exposure to hydroxychloroquine and a decreased rate of hospitalization from COVID-19 (OR 0.53; 95% CI, 0.29, 0.95). Sensitivity analyses revealed similar associations. QTc prolongation events occurred in 2% of patients prescribed hydroxychloroquine with no reported arrhythmia events among those with data available. Conclusions: In this retrospective observational study of SARS-CoV-2 infected non-hospitalized patients hydroxychloroquine exposure was associated with a decreased rate of subsequent hospitalization. Additional exploration of hydroxychloroquine in this mildly symptomatic outpatient population is warranted.

RR:C19 Evidence Scale rating by reviewer:

  • Misleading. Serious flaws and errors in the methods and data render the study conclusions misinformative. The results and conclusions of the ideal study are at least as likely to conclude the opposite of its results and conclusions than agree. Decision-makers should not consider this evidence in any decision.

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Review:

In this study the Authors aim to evaluate the association between hydroxychloroquine (HCQ) exposure and the subsequent progression of disease (in terms of hospitalization) in mildly symptomatic outpatients with documented SARS-CoV-2 infection. The results show that HCQ exposure was associated with a decreased rate of subsequent hospitalization.

Comments:

- The study did not consider the intensity of symptoms.
- Was the compliance of treatment with HCQ available?
- Table 1: The adverse events are related only to QT prolongation or arrhythmia event. Were only these two AE were detected?
- Table 2: only some comorbidities and symptoms were included in the multivariate analysis. Please clarify why only these were included.
- Figure 2: At time 0 (0 days from diagnosis), the percentage of non-hospitalization was 100% for patients treated with HCQ but the percentage of non-hospitalization for patients not treated with HCQ was 85%. Please clarify why because this percentage, at time 0, should be the same of patients treated with HCQ. In this case, the two curves should overlap, and no statistical differences should be revealed. Moreover, in Table 1 the association of the HCQ exposure and hospitalization was not statistically significant. The conclusion of the study should be that HCQ exposure does not decrease the rate of subsequent hospitalization.

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