COVID-19 related ARDS intensive care: The Nubilaria ACTide experience
Yghea and Nubilaria happy to donate project management and the eClinical platform.
Thanks to a synergy between private companies and public health structures, a real-world study has been started to support resuscitation of patients with COVID-19 related ARDS – Acute Respiratory Distress Syndrome. DECEIVER study will allow healthcare professionals to collect, share and analyze data in order to identify the best intervention strategy.
This collaboration has been given a green light by Italian health authorities to start trial DECEIVER in support of resuscitation of Coronavirus patients.
“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 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”
“For us, it was only natural to make our clinical research experience available free-of-charge to achieve this primary goal”,
says Eleonora Romagnoli, Scientific Director of Yghea, a Contract Research Organization of Ecol Studio SpA.
On this basis, the initiative of a study was developed, focussing on resuscitators concerned with the care of patients affected by Coronavirus. The research will be conducted under the direction of Yghea, a contract research organization of Ecol Studio SpA, with the pro bono collaboration of the eClinical provider Nubilaria Srl, and the Electronic Data Capture solution called ACTide.
The study’s purpose is to collect and analyze data linked to ventilation practices, in order to identify:
- Best ventilatory strategies for patients requiring orotracheal intubation
- Optimal weaning
- Return to autonomous breathing
How to organize a rigorous trial in emergency time?
Also, it was only natural for Yghea to ask Nubilaria for help, trusting in the pro bono and the immediate, unconditional collaboration between the two teams.
Nubilaria 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 were managed by Yghea, with the intervention of Nubilaria for the supplier test, study validation, deployment on a GAMP5, EU GMP Annex 11 eClinical platform named ACTide. All the process was completed in one week, in full compliance with workflow and SOPs commonly followed in intervention trials.
The data collection from the “first line” of resuscitations began on Monday 30th of March as soon as the go-ahead 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 most affected by the COVID-19 disease.
The data collection represents only the first phase of the study DECEIVER trial (which full title reads: Predictive factors of rapid weaning in patients affected by ARDS COVID-19 related), which will be conducted under the supervision of a purposely established scientific committee (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. We at Nubilaria are highly committed, now and in the future, and we will do whatever it takes to run the DECEIVER trial in terms of eClinical solutions with to support an adaptive trial and rapid project management by Yghea: 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.
That’s the reason why we reinforce our message for other non-profit SARS-Cov-2 related research programs:
The ACTide EDC platform and the eClinical tools for design, deploy, are for free, as well as our technical support and consultancy.
“This is a clinical study characterized by a highly pragmatic approach”
explains Eleonora Romagnoli
“It arises, in fact, from the urgent request of the resuscitators themselves. The immediate availability of data and information is essential to allow them to make effective choices at the right time. Giving timely answers to those operating in emergency situations is the primary goal of this study”.
The management of Area Vasta Romagna, the structure of reference to all hospital facilities in the region between Riccione and Faenza, was the first to respond positively and proactively to the proposed study.
Their reaction was then quickly followed up by the direction of the hospital centers in the great-Bologna area. The study begins in one of the national territories most affected by the current emergency and it promotes the need to identify, on several levels, effective tools in the fight against Coronavirus diseases.
According to Claudio Fornari, CEO of Ecol Studio SpA
“Yghea’s contribution represents the best way to be useful to the country in these tragic moments.
Today, every company has a duty to make the skills of its human resources available to the community if these can be of any help to those who fight on the front of this real battle.
I am convinced that the contribution of the Yghea team, thanks to the collaboration of an important partner such as Nubilaria ACTide and the synergy with the national health service will help to identify the best intervention strategies on patients affected by COVID-19.
Today more than ever, this is the social duty of every entrepreneur: to contribute to protecting people”.