A real-world clinical study has started, thanks to a collaboration between private companies and public health organisations, to support resuscitation of COVID-19 patients suffering from ARDS (Acute Respiratory Distress Syndrome).
Yghea, a Contract Research Organization (CRO) of Ecol Studio SpA, has teamed up with Nubilaria Srl under the coordination of the Maggiore Hospital of Bologna, to launch a clinical study in support of the resuscitation departments of the hospital.
The COVID-19 Deceiver study will give clinical professionals the opportunity to collect, share and analyse data in order to identify the best intervention strategy.
Free ACTide EDC to help ICUs tackle COVID- 19 related ARDS
Italian healthcare authorities have approved the collaboration to start the deceiver trial in support of intensive care for COVID-19 patients. Facing a surge in acute cases, Intensive Care Units (ICUs) in Italy and across Europe are under unprecedented pressure, facing a surge in acute coronavirus cases.
Eleonora Romagnoli, Scientific Director of Yghea, a CRO of Ecol Studio SpA, says:
“In Italy, the current severity of the emergency linked to the COVID-19 is subjecting hospital structures to unprecedented stress: intensive care units are literally overwhelmed and health workers are dealing with a number of patients far greater than the capacity of the available resources”.
An urgent request for essential data arises from the frontline healthcare operators. The immediate availability of data and information is essential to allow them to make effective choices at the right time. The Scientific Director of Yghea added:
“For us, it was only natural to make our clinical research experience available free of charge to achieve this primary goal”
The COVID-19 ARDS study initiative was developed on the basis of these urgent ICU needs. Focussing on resuscitators concerned with the care of patients affected by COVID-19, the research will be conducted under the direction of Yghea, a CRO of Ecol Studio SpA. E-Clinical solutions provider Nubilaria Srl will support the pro bono study efforts by providing it’s cutting edge Electronic Data Capture (EDC) system called ACTide EDC free of charge.
EDC analytics to save lives
The study will incorporate the ACTide EDC platform for free to collect and analyse data linked to ventilation practices for COVID-19 patients, in order to identify:
- The best ventilatory strategies for patients requiring orotracheal intubation
- Optimal weaning
- Return to autonomous breathing
It is common sense for Yghea to turn to Nubilaria for help in this task, trusting in the pro bono and the immediate, unconditional collaboration and natural synergy between the two teams.
Organising a rigorous trial in an emergency setting
Nubilaria has provided the design tool for the definition of the requirements, the publication of the first draft of the eCRF and the review and approval process with the Scientific Committee.
These activities are overseen and managed by Yghea, with the intervention of Nubilaria for the supplier test, study validation and deployment on a GAMP5, EU GMP Annex 11 eClinical platform named ACTide. The whole process was compiled and completed within a week, in full compliance with workflow and Standard Operating Procedures (SOPs) commonly followed in clinical intervention trials.
Data collection from the “first line” of resuscitations commenced on the 30th of March, as soon as the green light was received from the General Direction of the Policlinico Sant’Orsola-Malpighi, the University Hospital of Bologna and from the AUSL Area Vasta Romagna, a Local Healthcare Service Department covering a wide territory up to Rimini – Riccione, one of the hardest-hit regions by the COVID-19 disease.
The data collection represents only the first phase of the Deceiver trial titled “Predictive factors of rapid weaning in patients affected by ARDS COVID-19 related”. The study will be conducted under the supervision of a purposely established scientific committee, comprised of Doctors C. Capozzi, C. A. Mazzoli, S. Spadaro, E. Giampalma, coordinated by Dr. Lorenzo Gamberini MD, of the Anesthesia, Resuscitation Intensive Care and Territorial Emergency 118 operating unit of the Maggiore Hospital of Bologna. The study is conducted in full compliance with current privacy and GCP Good Clinical Practice regulations.
ACTide’s team will help: “Whatever it takes”
The team at Nubilaria is highly committed, now and in the future, and “will do whatever it takes” to run the study in terms of eClinical solutions to support an adaptive trial and rapid project management by Yghea.
Nubilaria’s team says:
“We want to help alleviate the suffering of people affected by COVID-19 and contribute to the development of knowledge and treatment of this terrible disease.”
Claudio Fornari, Sole Director of Ecol Studio SpA, commented:
Every company today has a duty to make the skills of its human resources available to the community if they can be of help to those who fight on the front of this real battle… ”
” … Important partners such as Nubilaria and the synergy with the national health service will help to identify the best intervention strategies on patients with Covid-19, fully realizing what it must be, today more than ever, the social role of every entrepreneur: to enhance and protect people. “
This is the reason why Nubilaria is reinforcing a message of support for other non-profit COVID-19 related research programs.
Nubilaria is currently offering its cutting edge ACTide EDC Free for non-profit European healthcare organisations to battle the COVID-19 pandemic.
For more info please contact: The ACTide Team
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