Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial
Gautret et al. (Journal of Antimicrobial Agents), 2020
Link to paper: https://doi.org/10.1016/j.ijantimicag.2020.105949
Gautret et al. describe a multi-centre clinical study around Marseille and Southern France in which a small cohort of patients was treated with hydroxychloroquine, an analogue of an antimalarial drug, alone or in combination with the antibiotic azithromycin. The authors suggest that hydroxychloroquine accelerates viral clearance, adding weight to a recent paper showing the effect of chloroquine on viral load in vitro. While it is a key to validate hydroxychloroquine in patients, this study lacks scientific rigor and does not provide clear clinical proof for the use of hydroxychloroquine in the treatment of SARS-CoV2 patients Firstly the study is underpowered, secondly several datapoints of increased disease burden have been excluded and lastly a large number of clinical parameters and results are not shown.
Does the study add to current knowledge? à Very limited although this study has had a massive impact on public opinion due to press coverage.
Does it challenge existing paradigms? à Not necessarily as chloroquine has been described to have potential antiviral properties
- Hydroxychloroquine seems to promote viral clearance (arguable as data acquisition lacks scientific rigor)
- Combination with antibiotic azithromycin may increase potency of drug
For treatment of SARS-COV-2 positive individuals
Repurposing of approved drugs as antiviral treatment
“Clinical trial” early results, 42 patients included, 26 cases – 16 controls
Viral clearance at day 6 post-inclusion nasopharyngeal samples
Strengths and weaknesses of the paper
Novelty: Combination therapy of chloroquine and azithromycin may be an option for pneumonic patients
Weakness: 6/26 treated-patients were excluded due to complications, deaths or treatment withdrawals while none of these patients were excluded in the untreated control group
As the authors do not present the actual viral Ct data on which the outcome of the study is based, it is impossible to evaluate whether the nasopharyngeal samples are positive or negative. Reproducibility: Likely low (due to negative patients recruited from another clinic) Appropriate statistics: No, as authors themselves state that study is underpowered due to low participant number
Findings easily translatable: Yes, however bigger clinical trial data will be required to verify these very early initial findings.