CSIC sponsor of two research-initiated clinical trials of antivirals against COVID-19

The Spanish National Research Council (CSIC) reports the results of two clinical trials of repositioning drugs proposed for the treatment of outpatients with COVID-19 at a meeting held at the Centro de Investigaciones Biológicas Margarita Salas (CSIC) on Wednesday, February 1, 2023.

These clinical trials, the result of interdisciplinary collaboration between scientists from PTI+ Global Health, are the first to have CSIC as the sole sponsor. The two repositioning drugs in the trials, bromhexine, and domperidone, were identified in the Translational Medicinal and Biological Chemistry laboratory of the CIB Margarita Salas.

The conference brought together 62 attendees, mostly physicians from the primary care centers of the Community of Madrid (CAM) participating in the clinical trials, as well as members of the Primary Care Assistance Management (GAAP) of the CAM, researchers from the Interdisciplinary Thematic Platform Global Health of the CSIC, PTI+ Global Health, who have led this research, and E-C-BIO, S.L., a support company for clinical research in charge of monitoring and statistical analysis in both trials.

PTI+ Global Health was created in March 2020 to respond to the health emergency caused by the COVID-19 pandemic and currently has 144 research groups from all fields of knowledge, whose joint work has enabled the first clinical trials of antivirals promoted by the CSIC to be completed. To this end, PTI+ Global Health has received funding from the European Recovery and Resilience Funds, NextGeneration EU (Regulation EU 2020/2094), as well as in-kind donations such as those made by ARQUIMEA, with PCR kits and analysis, and by SANOFI, with the donation of bromhexine.

For bromhexine, administered under the Bisolvon brand, a randomized multicenter study (EudraCT 2021-001227-41) and open-label of 28 days duration were carried out in 191 outpatients with mild to moderate COVID-19 from 19 primary care centers in the CAM, where the efficacy of the combined administration of this drug together with standard treatment (ST) was evaluated (n = 98) versus that of ST alone (n = 93). The results of this study have been published in The Journal of Clinical Medicine.

The efficacy of oral domperidone as an antiviral was evaluated in 173 outpatients with mild to moderate COVID-19 in the primary healthcare setting (17 participating CAM centers). This study was designed as a randomized double-blind multicenter (EudraCT 2021-001228-17) of 28 days duration with two arms, oral domperidone plus standard of care (SOC) (n = 87) versus placebo plus SOC (n = 86). The results, pending publication in The Journal of Clinical Medicine, show a reduction in viral load of the SARS-CoV-2 ORF1ab, Protein N and Protein S genes within several days of treatment.

Although the results have not been significant in relation to the control group, it should be noted that the CSIC through collaborative and interdisciplinary research instruments, such as the PTI+ Global Health, and with the help of European Recovery Funds and private donations, has demonstrated its ability to lead the results of biomedical research generated to clinical evidence through the promotion of investigator-initiated clinical trials, which are a priority axis in European research and innovation programs, such as Partnership Fostering a European Research Area for Health.

These actions are aligned with the Spanish Science, Technology, and Innovation Strategy 2021-2027, which has been designed to facilitate the articulation of our R&D&I policy with the EU science and innovation framework program and which includes activities aimed at solving the problems caused by COVID-19 as a tool for the social, economic and industrial reconstruction of our country. This exercise could represent a first step in the alignment with these global policies and positions the CSIC as an agent with initiative and scientific-technical, legal, and regulatory capacity to launch and finalize studies of this type.