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The
administration of colchicine added to standard therapy was safe and
well-tolerated. However, it was not linked with considerable improvements in
the inflammatory markers or clinical condition.
Compared to the standard therapy, colchicine therapy neither led to improvement in the clinical status nor the inflammatory response in hospitalized people infected with SARS-CoV-2, as per the findings of a recent study. COL-COVID trial was carried out to assess the effect of colchicine added to standard therapy vs standard therapy in hospitalized COVID-19 people that do not require mechanical ventilatory support.
In this open-label, prospective, phase III randomized controlled clinical trial,103 participants (52% male) were randomized to either the colchicine group (n=52) or the control group (n=51). Colchicine was commenced within the initial forty-eight hours of hospitalization at a 1.5 mg loading dose. This was followed by 0.5 mg twice a day for 1 week and 0.5 mg per day for twenty-eight days. Inflammatory biomarkers and clinical status (7-points WHO ordinal scale) were the endpoints ascertained.
On day twenty-eight, all participants in colchicine arm were alive and discharged. On the other hand, in the control group, 2 participants died in-hospital, and 1 participant remained hospitalized. Regarding alterations on the WHO scale at day 14 and 28 and time to 1-point clinical improvement, no profound inter-group differences were reported.
The clinical deterioration (rise of at least 1-point in the WHO scale) was noted in a greater percentage of cases in the colchicine arm (13.8%) when compared to the control arm (5.8%). Colchicine treatment was related to a reduced risk of clinical deterioration following adjustment by baseline risk factors and concomitant therapies.
The concentration of inflammatory
biomarkers (such as Interleukin-6, C-Reactive Protein) did not considerably
differ between the groups. After 28 days of treatment, colchicine therapy did
not produce a substantial advantage in terms of inflammatory response or
clinical improvement over the standard therapy. However, a preventive effect
for further clinical deterioration may be possible.
The International Journal of General Medicine
Colchicine in Recently Hospitalized Patients with COVID-19: A Randomized Controlled Trial (COL-COVID)
Domingo A Pascual-Figal et al.
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