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Treatment with an Anti-CK2 Synthetic Peptide Improves Clinical Response in COVID-19 Patients with Pneumonia. A
Leticia R Cruz1, Idania Baladrón2, Aliusha Rittoles1
1Central Hospital "Luis Diaz Soto", Havana 19130, Cuba.
Abstract:
The instrumental role of CK2 in the SARS-CoV-2 infection has pointed out this protein kinase as promising therapeutic target in COVID-19. 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. This trial aimed to explore the safety and putative clinical benefit of CIGB-325, an anti-CK2 peptide previously assessed in cancer patients. A monocentric, controlled, and therapeutic exploratory trial of intravenous CIGB-325 in adults hospitalized with COVID-19 was performed. 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). Adverse events were classified by the WHO Adverse Reaction Terminology. Parametric and nonparametric statistical analyses were performed according to the type of variable. Considering the small sample size, differences between groups were estimated by Bayesian analysis. CIGB-325 induced transient mild and/or moderate adverse events such as pruritus, flushing, and rash in some patients. Both therapeutic regimens were similar with respect to SARS-CoV-2 clearance in nasopharynx swabs over time. 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). Also, CIGB-325 significantly reduced the CPK (p = 0.007) and LDH (p = 0.028) plasma levels at day 7. Our preliminary findings suggest that this anti-CK2 clinical approach could be combined with standard-of-care in COVID-19 in larger studies.
Insights
This clinical trial explored CIGB-325, a novel anti-CK2 peptide, for COVID-19 treatment. CIGB-325 showed potential in reducing lung lesions and improving biomarkers, suggesting its use alongside standard care.
Area of Science:
- Virology
- Pharmacology
- Clinical Medicine
Background:
- Protein kinase CK2 plays a key role in SARS-CoV-2 infection.
- CK2 inhibitors show in vitro anti-SARS-CoV-2 activity.
- No clinical anti-CK2 approaches have been investigated for COVID-19.
Purpose of the Study:
- To explore the safety and clinical benefit of CIGB-325, an anti-CK2 peptide, in hospitalized COVID-19 patients.
- To evaluate CIGB-325 as a potential therapeutic agent for COVID-19.
Main Methods:
- A monocentric, controlled, exploratory trial involving 20 hospitalized COVID-19 adults.
- Patients received either CIGB-325 plus standard-of-care or standard-of-care alone.
- Safety was monitored via WHO Adverse Reaction Terminology; efficacy assessed by viral clearance, pulmonary lesions, and biomarkers (CPK, LDH). Bayesian analysis was used for small sample size comparisons.
Main Results:
- CIGB-325 was associated with transient, mild-to-moderate adverse events (pruritus, flushing, rash).
- No significant difference in SARS-CoV-2 clearance was observed between groups.
- CIGB-325 significantly reduced pulmonary lesions and plasma levels of CPK and LDH at day 7.
Conclusions:
- The anti-CK2 peptide CIGB-325 appears safe and potentially beneficial for COVID-19 patients.
- CIGB-325 demonstrated a positive impact on lung lesions and key biomarkers.
- Further investigation in larger studies is warranted to confirm the efficacy of CIGB-325 in combination with standard-of-care for COVID-19.
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