Outcomes of 3,737 COVID-19 patients treated with hydroxychloroquine/azithromycin and other regimens in Marseille, France: A retrospective analysis
Main result
- On 101,552 tests realised in 65,993 patients, 6,831 (10.4%) were SARS- CoV-2 positive. After the exclusion of more than half of the cohort, 3,737 infected patients were analyzed, 88% were under 65 (median age: 45 ) and 45.6% were men.
- 3,119 patients (83.5%) received hydroxychloroquine and azithromycin for at least 3 days.
- 18% were hospitalized, 6.2% developed severe symptoms, 5.3% were hospitalized for more than 10 days, 1.8% were transferred to ICU and 0.9% died. Adverse events happened for 4.5% with 0.67% with QT prolongation.
- Hospitalization duration was significatively shorter in the hydroxychloroquine and azithromycin group when compared with the "other treatments" group (7.3 vs 9.2 days) and hospitalization rate was reduced (3.5% vs 14.2%). Bi-therapy was associated with a lower death risk or ICU transfer: HR =0.49 [CI 95%: 0.25-0.97]
Takeaways
- It is suggested that hydroxychloroquine and azithromycin given early in COVID-19 disease can have a beneficial effect to reduce disease severity, therefore reducing ICU transfer or death.
- However, it is necessary to perform a study with a higher proof level to confirm the observed tendencies in this study that contains a high number of biases.
Strength of evidence Weak
-Retrospective study
-Lack of details on patient's follow-up
-Division of the cohort into several sub-groups, some with a few dozens of patients which induces a lack of power and increases the risk of a wrong conclusion (inflation of the alpha risk not acknowledged)
- In the end, the performed analysis is a per-protocol analysis when an analysis with intent to treat should have been done and all the patients which have not properly followed the bi-therapy should have been included in the same group to increase robustness
- Population not representative: the cohort is young with a majority of women, however, severe cases are in majority older males, which prevents concluding on mortality or ICU transfer.
Objectives
Method
- Retrospective monocentric open cohort study.
- Adults patients positive for SARS-CoV-2 were included at the Marseille's IHU and AP-HM then tested for 2 months (documented infection)
- Retrospective analysis of the cohort with collection of demographic and clinic data.
- Patients were treated with the bi-therapy: hydroxychloroquine 200mg 3 times a day for 10 days and azithromycin 500mg on the first day and then 250 mg every day for the next 4 days.
- Sub-group analysis includes patients receiving hydroxychloroquine alone or azithromycin alone or both for less than 5 days.
- Outcomes measured: death (major outcome), clinical pneumopathy evolution at 72h, ICU transfer, hospitalization for more than 10 days
- Statistical analysis with simple tests, mostly non-parametric and survival analysis with Kaplan-Meier curve and log-rank test then multivariate analysis adjusted with Charlson score, disease severity (NEWS-2 score), and received treatment (HCQ-AZ for at least 3 days). A Cox model was realized to measure the association between treatment and death. Then a propensity score with a logistic regression.
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