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

Ip, Andrew; Ahn, Jaeil; Zhou, Yandong; Goy, André; Hansen, Eric; Pecora, Andrew L.; Sinclaire, Brittany; Bednarz, Urszula; Marafelias, Michael; Mathura, Shivam; Sawczuk, Ihor S.; Underwood, Joseph P.; Walker, David; Prasad, Ramjee; Sweeney, Robert L.; Ponce, Marie G.; LaCapra, Samuel; Cunningham, F. J.; Calise, Arthur; Pulver, Bradley L.; Ruocco, Dominic; Mojares, Greggory E; Eagan, Michael P.; Ziontz, Kristy L.; Mastrokyriakos, Paul; Goldberg, Stuart L.

doi:10.1101/2020.08.20.20178772

Cited by 21 publications

(21 citation statements)

References 26 publications

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“…The use of hydroxychloroquine for the treatment of COVID-19 is controversial. Some studies have reported that this drug reduces mortality [ 18 ], but others have not confirmed this finding [ 19 ]. Our subjective clinical impression is that hydroxychloroquine can be useful in the first days of hospitalization.…”

Section: Discussionmentioning

confidence: 99%

First and second waves of coronavirus disease-19: A comparative study in hospitalized patients in Reus, Spain

et al. 2021

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Many countries have seen a two-wave pattern in reported cases of coronavirus disease-19 during the 2020 pandemic, with a first wave during spring followed by the current second wave in late summer and autumn. Empirical data show that the characteristics of the effects of the virus do vary between the two periods. Differences in age range and severity of the disease have been reported, although the comparative characteristics of the two waves still remain largely unknown. Those characteristics are compared in this study using data from two equal periods of 3 and a half months. The first period, between 15th March and 30th June, corresponding to the entire first wave, and the second, between 1st July and 15th October, corresponding to part of the second wave, still present at the time of writing this article. Two hundred and four patients were hospitalized during the first period, and 264 during the second period. Patients in the second wave were younger and the duration of hospitalization and case fatality rate were lower than those in the first wave. In the second wave, there were more children, and pregnant and post-partum women. The most frequent signs and symptoms in both waves were fever, dyspnea, pneumonia, and cough, and the most relevant comorbidities were cardiovascular diseases, type 2 diabetes mellitus, and chronic neurological diseases. Patients from the second wave more frequently presented renal and gastrointestinal symptoms, were more often treated with non-invasive mechanical ventilation and corticoids, and less often with invasive mechanical ventilation, conventional oxygen therapy and anticoagulants. Several differences in mortality risk factors were also observed. These results might help to understand the characteristics of the second wave and the behaviour and danger of SARS-CoV-2 in the Mediterranean area and in Western Europe. Further studies are needed to confirm our findings.

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Section: Discussionmentioning

confidence: 99%

First and second waves of coronavirus disease-19: A comparative study in hospitalized patients in Reus, Spain

et al. 2021

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“…Our findings are consistent with the results of several non-randomized controlled evaluations of HCQ outpatient therapy for COVID-19, which have reported substantial effectiveness. 4 5 6 7 8 9 In addition, a number of studies examining HCQ use in the hospitalized setting—particularly use starting within 24-48 hours of admission—have also shown benefit. 19 20 21 22 23 24 That modern, well-conducted non-randomized trials and observational studies would yield results similar to those of RCTs is not surprising as it is the common finding across numerous medical disciplines.…”

Section: Discussionmentioning

confidence: 99%

“…A large number of non-randomized but controlled trials have now shown benefit of HCQ when used early for treatment of high-risk outpatients. 4 5 6 7 8 9 Various randomized trials of HCQ for pre-exposure prophylaxis, post-exposure prophylaxis, and outpatient treatment have been performed. Individually, these clinical trials have yielded estimates of effectiveness that have not reached statistical significance.…”

Section: Introductionmentioning

confidence: 99%

Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

Ladapo

McKinnon

McCullough

et al. 2020

Preprint

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Objective--To determine if hydroxychloroquine (HCQ) reduces the incidence of new illness, hospitalization or death among outpatients at risk for or infected with SARS-CoV-2 (COVID-19). Design--Systematic review and meta-analysis of randomized clinical trials. Data sources--Search of MEDLINE, EMBASE, PubMed, medRxiv, PROSPERO, and the Cochrane Central Register of Controlled Trials. Also review of reference lists from recent meta-analyses. Study selection--Randomized clinical trials in which participants were treated with HCQ or placebo/standard-of-care for pre-exposure prophylaxis, post-exposure prophylaxis, or outpatient therapy for COVID-19. Methods--Two investigators independently extracted data on trial design and outcomes. Medication side effects and adverse reactions were also assessed. The primary outcome was COVID-19 hospitalization or death. When unavailable, new COVID-19 infection was used. We calculated random effects meta-analysis according to the method of DerSimonian and Laird. Heterogeneity between the studies was evaluated by calculation of Cochran Q and I2 parameters. An Egger funnel plot was drawn to investigate publication bias. We also calculated the fixed effects meta-analysis summary of the five studies. All calculations were done in Excel, and results were considered to be statistically significant at a two-sided threshold of P=.05. Results--Five randomized controlled clinical trials enrolling 5,577 patients were included. HCQ was associated with a 24% reduction in COVID-19 infection, hospitalization or death, P=.025 (RR, 0.76 [95% CI, 0.59 to 0.97]). No serious adverse cardiac events were reported. The most common side effects were gastrointestinal. Conclusion--Hydroxychloroquine use in outpatients reduces the incidence of the composite outcome of COVID-19 infection, hospitalization, and death. Serious adverse events were not reported and cardiac arrhythmia was rare. Systematic review registration--This review was not registered.

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“…The dataset and analysis supporting the conclusions of this article are available in the Synapse repository, unique DOI https://doi.org/10.7303/ syn22909530 [38]. The website link is https://www.synapse.org/#!Synapse: syn22909530/files/.…”

Section: Supplementary Informationmentioning

confidence: 98%

Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: a multi-center observational study

Ahn

Zhou

et al. 2021

BMC Infect Dis

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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.

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

Cited by 21 publications

References 26 publications

First and second waves of coronavirus disease-19: A comparative study in hospitalized patients in Reus, Spain

First and second waves of coronavirus disease-19: A comparative study in hospitalized patients in Reus, Spain

Randomized Controlled Trials of Early Ambulatory Hydroxychloroquine in the Prevention of COVID-19 Infection, Hospitalization, and Death: Meta-Analysis

Hydroxychloroquine in the treatment of outpatients with mildly symptomatic COVID-19: a multi-center observational study

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