From the very first days of the outbreak, ARENSIA took a high commitment to support the local communities by facilitating access to COVID-19 treatment options through clinical research. With an ever-growing pressure and increasing demand from both, patients and the industry, ARENSIA has been developing a dedicated infrastructure to support conduct clinical trials in COVID-19 patients and maximize outreach. Since the initiation of our 1st COVID-19 trial in Romania in summer 2020, ARENSIA has subsequently involved its locations in Moldova and Ukraine. As the latest step in this development, we are pleased to announce that in December 2020 ARENSIA further expanded its research capabilities in COVID-19 through the collaboration with Hospital No. 12, in the downtown area of Kyiv, Ukraine.
Being the second largest country in Europe by land area, Ukraine’s population is ~45M with approximately 1/10 living in the Kyiv greater area. Ukraine has seen spike in infections rates in the past few months, piking in November-December 2020 (~15K daily cases). Anticipating vaccine roll-out in February/March, local epidemiologists expect to see a large part of the population still contracting SARS-CoV-2 until the end of 2021.
Ukraine’s highly centralized healthcare system enabled a coordinated pandemic response by establishing dedicated specialized Reference Centers around the country. As part of the pandemic response plan, Hospital No. 12 – formerly a multi-therapeutic hospital – has been transformed into a COVID-19 center, fully focused on diagnostics and treatment of COVID-19 patients. Today, the hospital has 400 in-patient bed capacity and disposes on-site CT, X-ray, centralized oxygen supply system, diagnostics laboratory, etc. RT-PCR turn-around time is maximum 4-6 hrs. Patient care is being provided by skilled medical teams in accordance with National/WHO treatment protocols.
In collaboration with Hospital No. 12, ARENSIA is supporting trials with therapeutic compounds involving patients of all stages of COVID-19 severity as well as vaccine and prevention trials in healthy subjects. Highest standards for safety of study subjects, staff and visitors are in place. The research facilities include a large ambulatory department with separated circuits for “red” and “green” zones, as well as additional dedicated rooms for staff, pharmacy, sample preparation lab, sample storage facilities, meeting / conferencing rooms and a dedicated space for monitors.
Within the scope of the COVID-19 response, Ukrainian regulatory authorities are very supportive of clinical trials in COVID-19, prioritizing the review of COVID-19 protocols in 10 business days and a parallel submission to RA and EC.
Through a dedicated COVID-19 infrastructure in Ukraine and together with our COVID-dedicated partner hospitals in Romania and Moldova, ARENSIA offers unique abilities to conduct sophisticated Phase I-II-III protocols, including intensive PK/PD sampling, at the highest quality and speed.
We are happy to support existing or join new projects with innovative therapeutic or vaccine approaches in the fight against COVID-19!
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