Clinical outcomes and adverse events in patients hospitalised with COVID-19, treated with off-label hydroxychloroquine and azithromycin
Kelly et al.
, Clinical outcomes and adverse events in patients hospitalised with COVID-19, treated with off-label..
, British Journal of Clinical Pharmacology, doi:10.1111/bcp.14482
Retrospective 82 hospitalized patients HCQ/AZ, 52 SOC, not finding statistically significant differences. Confounding by indication
- authors note that the HCQ/AZ patients were more severely ill, and do not attempt to adjust for confounders.
This study is excluded in the after exclusion results of meta
substantial unadjusted confounding by indication
risk of death, 143.0% higher, RR 2.43, p = 0.03, treatment 23 of 82 (28.0%), control 6 of 52 (11.5%).
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kelly et al., 22 Jul 2020, retrospective, Ireland, peer-reviewed, 14 authors.
Abstract: Received: 19 May 2020
Revised: 3 July 2020
Accepted: 8 July 2020
Clinical outcomes and adverse events in patients hospitalised
with COVID-19, treated with off-label hydroxychloroquine and
Ròisìn O'Connor1,2 |
Eileen Relihan | Miriam Moriarty | Bernard Carr | Gail Melanophy |
Caitriona Doyle2 | Ciaran Bannan2,3 | Ruth O'Riordan2 | Concepta Merry2 |
Pharmacy Department, St James's Hospital,
Aims: To assess clinical outcomes and adverse drug events in patients hospitalised with
Department of Genitourinary Medicine and
Infectious Disease (GUIDe), Hospital 5 St
James's Hospital, Dublin, Ireland
COVID-19 treated with off-label hydroxychloroquine (HCQ) and azithromycin (Az).
positive polymerase chain reaction test for SARS-CoV-2 and received HCQ plus Az
Trinity College Dublin, Ireland
Ms Mary Kelly, Pharmacy Department St
James's Hospital Dublin 8, Ireland.
Methods: We performed a retrospective analysis of hospitalised patients who had a
or no targeted therapy. The primary end point was clinical improvement on day
7 defined as either hospital discharge or an improvement of 2 points on a 6-category
ordinal scale. Secondary outcomes included mortality at day 28, intensive care admission, requirement for mechanical ventilation and incidence of adverse events.
Results: Data from a total of 134 patients were evaluated; 82 patients received
HCQ/Az and 52 patients received no targeted therapy. Clinical improvement was
seen in 26.8% of patients who received HCQ/Az but this was not significant. The
rates of intensive care transfer and mechanical ventilation were higher in the
treatment group, but these differences were not significant. Mortality at day 28 was
significantly higher in the treatment group (P = .03). Hypoglycaemia elevated liver
function tests and QT prolongation were monitored in both groups. The risk of QT
prolongation was significantly higher in the treatment group. Treatment was stopped
early in 6 (7.3%) patients due to adverse events.
Conclusion: Although patients who received HCQ/Az were more severely ill the
administration of these repurposed drugs did not result in clinical improvement and
was associated with a significant increase in toxicity. This descriptive study highlights
the importance of monitoring all repurposed agents for adverse events.
adverse drug events, azithromycin, clinical pharmacy, COVID-19, hydroxychloroquine,
The authors confirm that the Principal Investigator (PI) for this paper is Professor Colm Bergin and that he had direct clinical responsibility for patients. The PI confirms that we have complied
with our institution's policies concerning research involving human subjects and the NREC policies for protection of human subjects.
Br J Clin Pharmacol. 2020;1–5.
© 2020 The British Pharmacological Society
KELLY ET AL.
1 | I N T RO D UC TI O N
Since December 2019, the newly emergent coronavirus (SARS-CoV-2)
has caused an ongoing pandemic of COVID-19.1–3 The disease
spectrum can range from a mild, uncomplicated illness managed in a
community setting to severe disease requiring intensive care support,
which may progress to death. In Ireland, as of 8 June 2020, there have
been 25 198 cases diagnosed, 1691..
is less effective
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