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Oral clarithromycin in COVID-19 of moderate severity: the ACHIEVE open-label trial using concurrent matched comparators
Preprint
in En
| PREPRINT-MEDRXIV
| ID: ppmedrxiv-20248753
ABSTRACT
Background:
To study the efficacy of oral clarithromycin in moderate COVID-19.Methods:
An open-label non-randomized trial in 90 patients with COVID-19 of moderate severity was conducted between May and October 2020. The primary endpoint was defined at the end-of-treatment (EOT) as no need for hospital re-admission and no progression into lower respiratory tract infection (LRTI) for patients with upper respiratory tract infection; and as at least 50% decrease of the respiratory symptoms score the without progression into severe respiratory failure (SRF) for patients with LRTI. Viral load, biomarkers, the function of mononuclear cells, and safety were assessed.Results:
The primary endpoint was attained in 86.7% of patients treated with clarithromycin (95% CIs 78.1-92.2%); this was 91.7% and 81.4% among patients starting clarithromycin the first 5 days from symptoms onset or later (odds ratio after multivariate analysis 6.62; p 0.030). The responses were better for patients infected by non-B1.1 variants. Clarithromycin use was associated with decreases in circulating C-reactive protein, tumour necrosis factor-alpha and interleukin (IL)-6; by increase of Th1 to Th2 mononuclear responses; and by suppression of SARS-CoV-2 viral load. No safety concerns were reported.Conclusions:
Early clarithromycin treatment provides most of clinical improvement in moderate COVID-19 (Trial Registration ClinicalTrials.gov, NCT04398004)
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Full text:
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Collection:
09-preprints
Database:
PREPRINT-MEDRXIV
Type of study:
Experimental_studies
/
Prognostic_studies
/
Rct
Language:
En
Year:
2020
Type:
Preprint