Introduction:

CIGB-258 is a peptide, whose mechanism of action has been associated with the inhibition of inflammation. This paper aims to demonstrate that CIGB-258 reduces hyperinflammation in COVID-19 patients.

Methods:

Pharmacokinetic and biodistribution profiles of the peptide labeled with iodine 125 [125I] were studied in Lewis rats. Thirteen critical COVID-19 patients and nine severe ones were included and treated, according to the protocol established (RPCEC00000313). Serum samples were obtained before and after treatment with CIGB-258, for the determination of biomarkers of inflammation.

Results:

Maximum concentration of peptide in blood from rats was at 0,5 to 1 h; and the half-life (t½) was calculated to be 6,3 to 6,9 hours. 48 h after the treatment with CIGB-258, clinical, radiological, and ventilation improvement was observed in all patients. C-reactive protein (CRP) levels significantly decreased after 72 h. CRP levels were inversely associated with oxygen uptake efficiency in the mechanical ventilation cohort in critical patients. Laboratory tests associated with hyperinflammation included white blood cell count with differential, ferritin, lactate dehydrogenase and calprotectin, which were gradually normalized. CIGB-258 led to a significant reduction of IL-6, TNF α and IL-10. Conclusion: CIGB-258 induced a clinical and radiological improvement in the patients, according with its pharmacokinetic and biodistribution profile. This improvement was associated with a decrease in biomarkers of systemic inflammation.

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