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.