Treatment with an Anti-CK2 Synthetic Peptide Improves Clinical Response in COVID-19 Patients with Pneumonia. A Randomized and Controlled Clinical Trial
Abstract
Background: The recently discovered instrumental role of CK2 in the SARS-Cov2 infection has pointed out this protein kinase as a promising therapeutic target in Covid-19 disease. Accordingly, anti-SARS-Cov2 activity has been reported by CK2 inhibitors in vitro, however any anti-CK2 clinical approach has been assessed in Covid-19 patients so far. Here, we investigated the putative clinical benefit of CIGB-325, an anti-CK2 peptide previously used in cancer patients, which was added to the standard-of-care to treat Covid-19. Methods: A monocentric, randomized standard-of-care controlled trial of intravenous CIGB-325 in adults hospitalized with Covid-19. Twenty patients were randomly assigned to receive CIGB-300 (2.5 mg/kg/day during 5-consecutive days) plus standard-of-care (10 patients) or standard-of-care (10 patients). Primary outcomes were time to viral clearance defined as the time (in days) to have nasopharyngeal SARS-Cov2 negative PCR and clinical response. This trial is registered with https://rpcec.sld.cu/trials/RPCEC00000317-En (Code: IG/CIGB300I/CV/2001). Results: Most of the patients had initial positive by chest-computed tomography (CT). CIGB-325 treatment reduced both number of pulmonary lesions and lesion's extent compared to control group in seven days. Taking into account the Covid-19 chest-CT abnormalities, CIGB-325 was also superior to control as well as in terms of proportion of patients with such clinical benefit. Improvement of clinical status was…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 325 participants or records.
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