Also, CIGB-325 significantly reduced the CPK ( p = 0.007) and LDH ( p = 0.028) plasma levels at day 7. However, CIGB-325 significantly reduced the median number of pulmonary lesions (9.5 to 5.5, p = 0.042) at day 7 and the proportion of patients with such an effect was also higher according to Bayesian analysis (pDif > 0 0.951). Both therapeutic regimens were similar with respect to SARS-CoV-2 clearance in nasopharynx swabs over time. CIGB-325 induced transient mild and/or moderate adverse events such as pruritus, flushing, and rash in some patients. Considering the small sample size, differences between groups were estimated by Bayesian analysis.
Parametric and nonparametric statistical analyses were performed according to the type of variable. Adverse events were classified by the WHO Adverse Reaction Terminology. Twenty patients were randomly assigned to receive CIGB-325 (2.5 mg/kg/day during 5-consecutive days) plus standard-of-care (10 patients) or standard-of-care alone (10 patients). A monocentric, controlled, and therapeutic exploratory trial of intravenous CIGB-325 in adults hospitalized with COVID-19 was performed. This trial aimed to explore the safety and putative clinical benefit of CIGB-325, an anti-CK2 peptide previously assessed in cancer patients. Anti-SARS-CoV-2 activity has been reported by CK2 inhibitors in vitro however, no anti-CK2 clinical approach has been investigated in COVID-19. The instrumental role of CK2 in the SARS-CoV-2 infection has pointed out this protein kinase as promising therapeutic target in COVID-19.
0 kommentar(er)
