Low-dose Hydroxychloroquine Therapy and Mortality in Hospitalized Patients with COVID-19: A Nationwide Observational Study of 8075 Participants

Author(s): Lucy Catteau , PharmD, PhD ^a ^, ^f ^, ⁱ ^, ^# , Nicolas Dauby , MD, PhD ^b ^, ^c ^, ^d ^, ^f ^, ⁱ ^, ^# ^, ^* , Marion Montourcy , MSc ^a ^, ^f ^, ⁱ , Emmanuel Bottieau , MD, PhD ^e ^, ^f ^, ⁱ , Joris Hautekiet , MSc ^a ^, ^g ^, ^f ^, ⁱ , Els Goetghebeur , PhD ^f ^, ⁱ ^, ^g , Sabrina van Ierssel , MD, PhD ^f ^, ⁱ ^, ^h , Els Duysburgh , MD, MPH, PhD ^a ^, ^f ^, ⁱ , Herman Van Oyen , MD, DrPH ^a ^, ^f ^, ^h ^, ⁱ , Chloé Wyndham-Thomas , MD, PhD ^a ^, ^f ^, ⁱ , Dominique Van Beckhoven , MD, MSc ^a ^, ^f ^, ⁱ , Belgian Collaborative Group on COVID-19 hospital surveillance

Publication date (Electronic): 24 August 2020

Journal: International Journal of Antimicrobial Agents

Publisher: Elsevier Ltd and International Society of Antimicrobial Chemotherapy.

Keywords: Hydroxychloroquine, COVID-19, SARS-CoV-2, mortality, observational study

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Highlights

•

Hydroxychloroquine (HCQ) 2400 mg during 5 days was used in Belgium for COVID-19
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Impact of HCQ on mortality among 8075 patients with COVID-19 was assessed
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Lower mortality in HCQ-treated patients as compared to supportive care
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Lower mortality is irrespective of symptoms duration

Abstract

Background

Hydroxychloroquine (HCQ) has been largely used and investigated as therapy of COVID-19 across various settings, at total dose usually ranging from 2400 mg to 9600 mg. In Belgium, off-label use of low-dose HCQ (2400 mg in total over five days) was recommended for hospitalized patients with COVID-19.

Methods

We conducted a retrospective analysis of in-hospital mortality in the Belgian national COVID-19 hospital surveillance data. Patients treated either with HCQ alone and supportive care (HCQ group) were compared to patients treated with supportive care only (no-HCQ group) using a competing risks proportional hazards regression with discharge alive as competing risk, adjusted for demographic and clinical features with robust standard errors.

Results

Of 8075 patients with complete discharge data on 24 ^th of May and diagnosed before the 1 ^st of May, 4542 received HCQ in monotherapy and 3533 were in the no-HCQ group. Death was reported in 804/4542 (17.7%) and 957/3533 (27.1%), respectively. In the multivariable analysis, the mortality was lower in the HCQ group compared to the no-HCQ group (adjusted hazard ratio [HR] 0.684, 95% confidence interval [CI] 0.617–0.758). Compared to the no-HCQ group, mortality in the HCQ group was reduced both in patients diagnosed ≤ 5 days (n=3975) and > 5 days (n=3487) after symptom onset (adjusted HR 0.701, 95% CI 0.617–0.796 and adjusted HR 0.647, 95% CI 0.525–0.797, respectively).

Conclusions

Compared to supportive care only, low-dose HCQ monotherapy was independently associated with lower mortality in hospitalized patients with COVID-19 diagnosed and treated early or later after symptom onset.

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Most cited references 34

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Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

Fei Zhou, Ting Yu, Ronghui Du … (2020)

Summary Background Since December, 2019, Wuhan, China, has experienced an outbreak of coronavirus disease 2019 (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Epidemiological and clinical characteristics of patients with COVID-19 have been reported but risk factors for mortality and a detailed clinical course of illness, including viral shedding, have not been well described. Methods In this retrospective, multicentre cohort study, we included all adult inpatients (≥18 years old) with laboratory-confirmed COVID-19 from Jinyintan Hospital and Wuhan Pulmonary Hospital (Wuhan, China) who had been discharged or had died by Jan 31, 2020. Demographic, clinical, treatment, and laboratory data, including serial samples for viral RNA detection, were extracted from electronic medical records and compared between survivors and non-survivors. We used univariable and multivariable logistic regression methods to explore the risk factors associated with in-hospital death. Findings 191 patients (135 from Jinyintan Hospital and 56 from Wuhan Pulmonary Hospital) were included in this study, of whom 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients). Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p<0·0001), and d-dimer greater than 1 μg/mL (18·42, 2·64–128·55; p=0·0033) on admission. Median duration of viral shedding was 20·0 days (IQR 17·0–24·0) in survivors, but SARS-CoV-2 was detectable until death in non-survivors. The longest observed duration of viral shedding in survivors was 37 days. Interpretation The potential risk factors of older age, high SOFA score, and d-dimer greater than 1 μg/mL could help clinicians to identify patients with poor prognosis at an early stage. Prolonged viral shedding provides the rationale for a strategy of isolation of infected patients and optimal antiviral interventions in the future. Funding Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences; National Science Grant for Distinguished Young Scholars; National Key Research and Development Program of China; The Beijing Science and Technology Project; and Major Projects of National Science and Technology on New Drug Creation and Development.

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Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

Mark Peters (2020)

Abstract Background Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. Results A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). Conclusions In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)

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Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area

Safiya Richardson, Jamie Hirsch, Mangala Narasimhan … (2020)

There is limited information describing the presenting characteristics and outcomes of US patients requiring hospitalization for coronavirus disease 2019 (COVID-19).

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Author and article information

Contributors

Nicolas Dauby

Journal

Journal ID (nlm-ta): Int J Antimicrob Agents

Journal ID (iso-abbrev): Int. J. Antimicrob. Agents

Title: International Journal of Antimicrobial Agents

Publisher: Elsevier Ltd and International Society of Antimicrobial Chemotherapy.

ISSN (Print): 0924-8579

ISSN (Electronic): 1872-7913

Publication date PMC-release: 24 August 2020

Publication date (Electronic): 24 August 2020

Electronic Location Identifier: 106144

Affiliations

[a ]Epidemiology and Public Health, Sciensano, Brussels

[b ]Department of Infectious Diseases, CHU Saint-Pierre, Brussels

[c ]Institute for Medical Immunology, Université Libre de Bruxelles (ULB)

[d ]Environmental Health Research Centre, Public Health School, Université Libre de Bruxelles (ULB), Brussels, Belgium

[e ]Department of Clinical Sciences, Institute for Tropical Medicine, Antwerp

[f ]Cancer Center, Sciensano, Brussels

[g ]Department of Applied Mathematics, Computer Science and Statistics, Ghent University, Ghent, Belgium

[h ]Department of General Internal Medicine, Infectious Diseases and Tropical Medicine, University Hospital Antwerp (UZA), Edegem, Belgium

[i ]Public Health and Primary Care, Gent University, Gent

Author notes

[* ]Corresponding author: Nicolas Dauby, MD, PhD, Department of Infectious Diseases, CHU Saint-Pierre, School of Public Health, Université Libre de Bruxelles (ULB) Nicolas.dauby@ 123456ulb.ac.be

[#]

Equal Contribution

Article

Publisher ID: S0924-8579(20)30342-3 Publisher ID: 106144

DOI: 10.1016/j.ijantimicag.2020.106144

PMC ID: 7444610

PubMed ID: 32853673

SO-VID: 0e81707e-5af1-4dd9-8a03-d65ccf065adc

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Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.

Low-dose Hydroxychloroquine Therapy and Mortality in Hospitalized Patients with COVID-19: A Nationwide Observational Study of 8075 Participants

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Novel Coronavirus Disease COVID-19

Most cited references 34

Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study

Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

Presenting Characteristics, Comorbidities, and Outcomes Among 5700 Patients Hospitalized With COVID-19 in the New York City Area

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