Outcomes of 2111 COVID-19 Hospitalized Patients Treated with Hydroxychloroquine/Azithromycin and Other Regimens in Marseille, France, 2020: A Monocentric Retrospective Analysis

Lagier, Jean-Christophe; Million, Matthieu; Cortaredona, Sébastien; Delorme, Léa; Colson, Philippe; Fournier, Pierre‐Edouard; Brouqui, Philippe; Raoult, Didier; Parola, Philippe

doi:10.2147/tcrm.s364022

Cited by 7 publications

(5 citation statements)

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“…This report does not aim to contribute to knowledge of the efficacy of treating COVID-19 with HCQ-AZ. Indeed, we have reported our 2020 data elsewhere [ 5 , 6 ]. More results will soon be discussed in the SARS-CoV-2 variant vaccination and post-vaccination era.…”

Section: Discussionmentioning

confidence: 99%

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Cardiovascular Safety of Hydroxychloroquine–Azithromycin in 424 COVID-19 Patients

et al. 2023

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Background and Objectives: Hydroxychloroquine (HCQ) combined with azithromycin (AZM) has been widely administered to patients with COVID-19 despite scientific controversies. In particular, the potential of prolong cardiac repolarization when using this combination has been discussed. Materials and Methods: We report a pragmatic and simple safety approach which we implemented among the first patients treated for COVID-19 in our center in early 2020. Treatment contraindications were the presence of severe structural or electrical heart disease, baseline corrected QT interval (QTc) > 500 ms, hypokalemia, or other drugs prolonging QTc that could not be interrupted. Electrocardiogram and QTc was evaluated at admission and re-evaluated after 48 h of the initial prescription. Results: Among the 424 consecutive adult patients (mean age 46.3 ± 16.1 years; 216 women), 21.5% patients were followed in conventional wards and 78.5% in a day-care unit. A total of 11 patients (2.6%) had contraindications to the HCQ-AZ combination. In the remaining 413 treated patients, there were no arrhythmic events in any patient during the 10-day treatment regimen. QTc was slightly but statistically significantly prolonged by 3.75 ± 25.4 ms after 2 days of treatment (p = 0.003). QTc prolongation was particularly observed in female outpatients <65 years old without cardiovascular disease. Ten patients (2.4%) developed QTc prolongation > 60 ms, and none had QTc > 500 ms. Conclusions: This report does not aim to contribute to knowledge of the efficacy of treating COVID-19 with HCQ-AZ. However, it shows that a simple initial assessment of patient medical history, electrocardiogram (ECG), and kalemia identifies contraindicated patients and enables the safe treatment of COVID-19 patients with HCQ-AZ. QT-prolonging anti-infective drugs can be used safely in acute life-threatening infections, provided that a strict protocol and close collaboration between infectious disease specialists and rhythmologists are applied.

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Section: Discussionmentioning

confidence: 99%

“…HCQ-AZM have been widely administered to patients, and observational studies with thousands of cases have been published throughout the world [ 4 ]. In our center in 2020, this combination was associated with lower mortality among 2111 COVID-19 hospitalized patients [ 5 ] and 10,429 COVID-19 outpatients [ 6 ].…”

Section: Introductionmentioning

confidence: 99%

Cardiovascular Safety of Hydroxychloroquine–Azithromycin in 424 COVID-19 Patients

et al. 2023

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“…We then checked the robustness of the results published in our previous studies on patients treated for COVID-19 in our Institute [10][11][12]. We did not detect any statistically significant differences in the number of deaths and transfers to ICU compared to those published in these three studies (Table 1).…”

Section: Retrospective Analysis Of Published Papermentioning

confidence: 93%

“…This inspired us to collect unbiased raw data and share it with the scientific community. In order to the database was findable, accessible, interoperable, and reusable (FAIR) and as transparent as possible, we used raw data from different administrative sources, including hospital admission files and pharmacy prescription files, while recorded deaths were obtained from the French National Death Registry held by the Institut National des Statistiques et des Études Économiques (INSEE) (12). With this information we generated a retrospective cohort dataset of 30423 COVID-19 patients.…”

Section: Introductionmentioning

confidence: 99%

"Construction, Quality Control and Regulatory Aspect of a Database of 30,423 COVID-19 Patients Cared for at the IHU Méditerranée Infection France"

Brouqui

2023

BJSTR

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“…The first one [2], has been adjudicated to be fraudulent by the former President of the board of this institute [3]. Further COVID-19 research has had significant ethical concerns arise, regarding the conduct of the studies [4,5,6,7,8] due to their purported retrospective nature despite the trial description appearing to be a prospective trial. These trials are also prima facie problematic because, from May the 11th 2020 and the removal of a special decree authorizing it temporarily, the use of hydroxychloroquine was forbidden outside of clinical trials in France, and these were not conducted as clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Are we done with Hydroxychloroquine for COVID-19? Studies with ethical, legal, and methodological concerns must now be retracted

FRANK,

Barriere,

Gorski

et al. 2023

Preprint

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On October 30th, a new study from the Institut Hospitalo-Universitaire Méditerranée Infection (IHU-MI) was published in the journal “New Microbes and New Infections” [1]. This is the latest publication in a long series that is controversial both scientifically and legally.Indeed, several other articles had been published by this team on the topic of Covid-19. The first one [2], has been adjudicated to be fraudulent by the former President of the board of this institute [3]. Further COVID-19 research has had significant ethical concerns arise, regarding the conduct of the studies [4,5,6,7,8] due to their purported retrospective nature despite the trial description appearing to be a prospective trial. These trials are also prima facie problematic because, from May the 11th 2020 and the removal of a special decree authorizing it temporarily, the use of hydroxychloroquine was forbidden outside of clinical trials in France, and these were not conducted as clinical trials. Similarly, off-label prescription was not possible in that case because this process is subject to a strict law regulation in France and can be proposed to patients only if: i) there is no alternative labeled therapy, ii) it is used case by case and not systematically for all patients as was the case at the IHU and iii) the available scientific data ensures efficacy and safety of the drug in the dedicated indication (see Code de la Santé Publique, Article L5121-12-1-2), which was clearly not the case for hydroxychloroquine in COVID-19 treatment. Consequently, since hydroxychloroquine is considered in this indication as an experimental drug in France, a retrospective design likely contravenes French law on biomedical research (see Code de la santé publique, Article L1121-1) [9].Despite all scientific and ethics arguments having been brought to the attention of the editor, and the publisher themselves declaring that the study has no scientific merit and is “fully irresponsible” [10] even prior to the fraud being uncovered, the initial publication has still not been retracted [11].

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Outcomes of 2111 COVID-19 Hospitalized Patients Treated with Hydroxychloroquine/Azithromycin and Other Regimens in Marseille, France, 2020: A Monocentric Retrospective Analysis

Cited by 7 publications

References 52 publications

Cardiovascular Safety of Hydroxychloroquine–Azithromycin in 424 COVID-19 Patients

Cardiovascular Safety of Hydroxychloroquine–Azithromycin in 424 COVID-19 Patients

"Construction, Quality Control and Regulatory Aspect of a Database of 30,423 COVID-19 Patients Cared for at the IHU Méditerranée Infection France"

Are we done with Hydroxychloroquine for COVID-19? Studies with ethical, legal, and methodological concerns must now be retracted

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