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Clinical Outcomes and Adverse Drug Events Identified in Patients Treated with Hydroxychloroquine and Azithromycin
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  • Mary Kelly,
  • Roisin OConnor,
  • Liam Townsend,
  • Miriam Coghlan,
  • Eileen Relihan,
  • Bernard Carr,
  • Miriam Moriarty,
  • Caitriona Doyle,
  • Ciaran Bannan,
  • Ruth O'Riordan,
  • Susie Clarke,
  • Concepta Merry,
  • Gail Melanophy,
  • Colm Bergin
Mary Kelly
St James's Hospital
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Roisin OConnor
Saint James's Hospital
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Liam Townsend
9Department of GU Medicine and Infectious Diseases, St. James's Hospital
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Miriam Coghlan
St James's Hospital
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Eileen Relihan
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Bernard Carr
St James's Hospital
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Miriam Moriarty
St James's Hospital
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Caitriona Doyle
Saint James's Hospital
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Ciaran Bannan
Saint James's Hospital
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Ruth O'Riordan
Saint James's Hospital
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Susie Clarke
Saint James's Hospital
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Concepta Merry
Saint James's Hospital Physiotherapy Department
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Gail Melanophy
Pharmacy Department, St. James's Hospital
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Colm Bergin
Saint James's Hospital
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Abstract

Aim To assess clinical outcomes and adverse drug events in patients hospitalised with COVID -19 treated with off- label hydroxychloroquine and azithromycin. Methods We performed a retrospective analysis of hospitalised COVID-19+ patients who received hydroxychloroquine plus azithromycin over a 2 week period. The primary end point was clinical improvement on day 7 defined as either hospital discharge or an improvement of two points on a six-category ordinal scale. Secondary outcomes evaluated included mortality at day 28, ICU admission, requirement for mechanical ventilation and incidence of adverse drug events. Results Data from a total of 82 patients with laboratory confirmed SARS-CoV-2 infection was evaluated. Clinical improvement was seen in 26.8% of patients at Day 7. 31% of patients were admitted to ICU, 16 (19.5%) underwent mechanical ventilation and Day 28 mortality was 28%. Age over 70, history of cardiovascular disease and 3 or more comorbidities were risk factors for mortality. The incidence of adverse drug events was 42%. No patient experienced a Grade 4 or 5 toxicity. Over a fifth of patients (23) had raised LFTs (65% had raised LFTs at baseline), 11 patients experienced prolonged QT and 1 patient experienced grade 1 hypoglycaemia. Treatment was stopped early in 6(7.3%) patients due to prolonged QT interval or LFT elevations. Conclusion This descriptive study details the clinical outcomes of COVID-19 positive patients treated with these agents and highlights the importance of monitoring all repurposed agents for adverse drug events.

Peer review status:ACCEPTED

15 May 2020Submitted to British Journal of Clinical Pharmacology
20 May 2020Submission Checks Completed
20 May 2020Assigned to Editor
27 May 2020Review(s) Completed, Editorial Evaluation Pending
27 May 2020Editorial Decision: Revise Minor
17 Jun 20201st Revision Received
18 Jun 2020Assigned to Editor
18 Jun 2020Submission Checks Completed
18 Jun 2020Review(s) Completed, Editorial Evaluation Pending
23 Jun 2020Editorial Decision: Revise Minor
24 Jun 20202nd Revision Received
25 Jun 2020Submission Checks Completed
25 Jun 2020Assigned to Editor
25 Jun 2020Review(s) Completed, Editorial Evaluation Pending
02 Jul 2020Editorial Decision: Revise Minor
03 Jul 20203rd Revision Received
06 Jul 2020Submission Checks Completed
06 Jul 2020Assigned to Editor
06 Jul 2020Review(s) Completed, Editorial Evaluation Pending
08 Jul 2020Editorial Decision: Accept