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Apparent inefficacy of hydroxychloroquine combined with azithromycin on SARS-CoV-2 clearance in an incident cohort of geriatric patients with COVID-19

Mazzitelli et al., Travel Medicine and Infectious Disease, 37, doi:10.1016/j.tmaid.2020.101826
Jul 2020  
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Report on HCQ+AZ use in 41 elderly high-risk patients. 29 of 30 patients with treatment >= 5 days survived. Only 10% were PCR negative after one week, however the Ct value is not specified.
Mazzitelli et al., 31 Jul 2020, peer-reviewed, 8 authors.
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Apparent inefficacy of hydroxychloroquine combined with azithromycin on SARS-CoV-2 clearance in an incident cohort of geriatric patients with COVID-19
Maria Mazzitelli, Chiara Davoli, Vincenzo Scaglione, Paolo Fusco, Valentina La Gamba, Giovanni Matera, Enrico Maria Trecarichi, Carlo Torti
Travel Medicine and Infectious Disease, doi:10.1016/j.tmaid.2020.101826
Gautret at al. published results of non-randomized studies suggesting efficacy of hydroxychloroquine and azithromycin (HCQ/AZI) in patients with COVID-19 [1,2]. Particularly, among 80 mildly infected patients, 83% at day 7 and 93% at day 8 achieved negative results of RT-PCR for SARS-CoV-2 from nasopharyngeal swabs [2]. More recently, data from a multicenter study of 1061 patients were published, showing that all but one patient were PCR-cleared at day 15 [3]. Following the extraordinary success rate of the first study [1], we started prescribing HCQ/AZI in our patients, so from March 28th to April 4th, 2020, 41 patients took HCQ (200 mg thrice daily) and AZI 500 mg for the first day and 250 mg for the subsequent 4 days. All patients got infected from a unique outbreak in a long-term facility, with the date of infection estimated around a week before admission. So, in this study on an incident cohort, we minimized the risk of interpreting a rapid PCR clearance as an effect of the prescribed treatment, while such clearance may be simply spontaneous in patients infected for a longer time. Among 41 patients, ten died for severe COVID-19 (6 patients took treatment for ≤2 days, and 4 for <5 days), and one refused to be retested for SARS-CoV-2. So, 30 patients were evaluated after completion of the treatment course. Among them, 17 (51%) were females; median age was 83 years (IQR: 65-88). Recorded comorbidities were: hypertension (76.6%), neurological diseases (43.3%), chronic kidney disease (43.3%), and psychiatric disorders (33.3%). Nine (30%) patients were diagnosed with COVID-19 pneumonia (three requiring oxygen support). Twelve patients had upper respiratory symptoms. Five patients had respiratory failure without radiological evidence of pneumonia. Four patients were asymptomatic. Real time reverse transcriptase-polymerase chain reac-
Ethics approval and consent to participate Ethical approval of the protocol was obtained and consent for participation was obtained from each patients. Disclaimer The funding agencies had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Authors' contributions All authors conceived the study, carried out the analysis, discussed the results, drafted the first manuscript, revised the manuscript, and gave final approval for publication. Declaration of competing interest The authors declared no competing interests.
Gautret, Lagier, Parola, Hoang, Meddeb et al., Clinical and microbiological effect of a combination of hydroxychloroquine and azithromycin in 80 COVID-19 patients with at least a six-day follow up: a pilot observational study, Trav Med Infect Dis, doi:10.1016/j.tmaid.2020.101663
Gautret, Lagier, Parola, Hoang, Meddeb et al., Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial, Int J Antimicrob Agents, doi:10.1016/j.ijantimicag.2020.105949
Mazzitelli A, Davoli A, Scaglione A, Fusco A, La Gamba A et al., Carlo Torti a a Infectious and Tropical Disease Unit
Million, Lagier, Gautret, Colson, Fournier et al., Early treatment of COVID-19 patients with hydroxychloroquine and azithromycin: a retrospective analysis of 1061 cases in marseille, France, Trav Med Infect Dis, doi:10.1016/j.tmaid.2020.101738
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