Tue Jan 26 2021
suPARnostic® can become the first companion diagnostic device to aid in selecting and excluding COVID-19 patient groups for drug treatment.
The product is already deployed for risk stratification and patient management of COVID-19 patients in European hospitals.
We have initiated a clinical study that will be conducted in collaboration with HISS (Hellenic Institute for the Study of Sepsis) to clinically validate suPARnostic® for guiding early anakinra treatment of COVID-19 patients.
An exploratory study from October 2020, currently undergoing peer review, shows initial positive results using suPAR-guided anakinra treatment to prevent severe respiratory failure (SRF) for COVID-19 patients. The reported data include 130 COVID-19 patients with suPAR levels above 6 ng/mL undergoing anakinra treatment and 130 matched controls who did not receive anakinra treatment. Results showed that the incidence of SRF among treated patients was 22.3% compared to 59.2% among untreated comparators. Mortality after 30 days was 11.5% and 22.3%, respectively.
HISS has initiated a study to clinically validate the exploratory study’s findings.
The study is an interventional, confirmatory, phase III randomized clinical trial (RCT) aiming to evaluate the efficacy and safety of early start of anakinra treatment guided by suPAR in COVID-19 patients in improving the clinical outcome for COVID-19 patients over 28 days. The study will enroll 600 patients across 42 hospitals in Greece and Italy. The primary outcome is measured by the ordinal scale of the 11-point WHO clinical progression scale ranging from the best outcome (asymptomatic) to the worst outcome (death). Secondary outcomes such as cost of hospitalization, time until discharge and rate of adverse events will also be measured. We will provide suPARnostic® test kits for the clinical trial.
Since 2019, the suPARnostic® TurbiLatex and Quick Triage products have been deployed across various hospitals in Europe, including for COVID-19 patients since March 2020. We have recently scaled up the production to meet the expected increased demand from customers using the product for COVID-19 patient management.
“If the interim results are validated in the randomized clinical trial, the implication for healthcare professionals working with the management of COVID-19 patients can be significant.”
MD, PhD., Hellenic Institute for the Study of Sepsis
Evangelos Giamarellos-Bourboulis, MD, Ph.D., Hellenic Institute for the Study of Sepsis, said:
“Our interim analysis of 130 patients using suPAR-guided anakinra treatment of COVID-19 patients showed promising results in significantly decreasing mortality, the incidence of severe respiratory failure, and the median cost of hospitalization. If the interim results are validated in the randomized clinical trial, the implication for healthcare professionals working with the management of COVID-19 patients can be significant.”
Jakob Knudsen, Chief Executive Officer of ViroGates, says:
”We are delighted to enter a partnership with HISS to clinically validate our suPARnostic® product as potentially the first companion diagnostic device used in the process to assess patients eligible for treatment for COVID-19 disease. The hospital systems currently face severe crowding in acute and intensive care functions. The ability to identify COVID-19 patients for early treatment can potentially save lives, reduce costs, and ease the burden on national health care systems.”