Ευεργετικά αποτελέσματα της κολχικίνης για μέτρια έως σοβαρή COVID-19: μια τυχαιοποιημένη, διπλά τυφλή, ελεγχόμενη με εικονικό φάρμακο κλινική δοκιμή
Η κολχικίνη μπορεί να μειώσει την ανάγκη για συμπληρωματική θεραπεία οξυγόνου και τη διάρκεια της νοσηλείας σε ασθενείς με μέτρια έως σοβαρή νόσο κοροναϊού 2019 (COVID-19), σύμφωνα με αυτή τη μικρή μελέτη.
Αρχεία:
ORIGINAL RESEARCH
Beneficial effects of colchicine for moderate to severe COVID-19: a randomised, double-blinded, placebocontrolled clinical trial
Outcomes
At least half of the patients receiving colchicine stopped using supplemental oxygen for the fourth day (median 4.0; IQR 2.0–6.0days) of intervention, while the same happened to the patients receiving placebo on the seventh day (median 6.5; IQR 4.0–9.0days; p<0.001). Significant difference (p=0.003) between the groups was found for the time of hospitalisation, in detriment of the placebo group (median 7.0; IQR 5.0–9.0days vs median 9.0; IQR 7.0–12.0days).
The majority of adverse events (table 2) was mild (exception for pneumonia) and, to some extent, attributable to the viral infection itself or its complications, not entailing patients withdrawal. It seems to be the case of aspartate aminotransferase and alanine aminotransferase transient elevations, under 3× the upper limit of normal, with no difference between the groups (data not shown). New or worsened diarrhoea was more frequent in the intervention group (17% vs 6%). None of the patients suffered dehydration, and the diarrhoea was controlled with the prescription of an antisecretory agent (eg, racecadotril). Cardiac adverse events, undoubtedly the main issue on the use of hydroxychloroquine and/or azithromycin for COVID-19, did not have an augmented frequency by adding colchicine. No participant had QT interval above 450 ms during the observational period (data not shown). No difference between the groups on QT interval variation was observed from the value of day 0 to the highest value.
CONCLUSIONS Patients who received colchicine in this randomised, double-blinded, placebo-controlled clinical trial presented better evolution in terms of the need for supplemental oxygen and the length of hospitalisation. Serum CRP was a laboratory marker of clinical improvement. Colchicine was safe and well tolerated. Clinical trials with larger numbers of patients should be conducted to further evaluate the efficacy and safety of colchicine as an adjunctive therapy for hospitalised patients with moderate to severe COVID-19.
Author affiliations 1 Department of Internal Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil 2 Department of Pharmacology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil 3 Department of Cell Biology, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil 4 Department of Emergency Medicine, Ribeirao Preto Medical School, University of Sao Paulo, Ribeirao Preto, Brazil 5
