NOXCOVID COVID-19 Clinical Trial
A Dose Escalation and Dose Expansion Study of NOX66 in the Treatment of COVID-19 Infection
Veyonda® in combination with standard care in patients hospitalised with moderate COVID-19 disease
Objectives - to demonstrate that in COVID-19 patients at risk of developing a cytokine storm and septic shock:
- Veyonda® is safe and well tolerated, and
- Veyonda® can halt the deterioration of COVID-19 patients and progression to septic shock
The novel and unique anti-inflammatory action of Veyonda®, via the STING signaling pathway, could potentially prevent progression of COVID-19 disease.
The aim is to prevent the onset of the cytokine storm that inflicts tissue damage in the lungs and other major organs, aggravating lung damage and requiring mechanical ventilation and potentially causing death.
There is potential that this activity could extend to other causes of septic shock.
A Phase 1 dose-escalation and dose-expansion study focusing on safety and proof-of-principle endpoints (biomarker and clinical responses) - underway
Contract research organisation, Clinical Accelerator, is overseeing the Europe based trial. The clinical protocol has been designed acting on the advice of Australian, U.S. and European clinicians, and incorporating FDA recommendations. The trial is being conducted at a number of sites with high rates of COVID-19 cases.
Approximately 40 patients who have been admitted to hospital for respiratory insufficiency (not requiring artificial ventilation) associated with the SARS-CoV-2 virus will be recruited and patients are treated for 14 days.
Trial results to be announced following the analysis of final data.
Veyonda® is currently not approved in Australia or any other country