A randomised, 2x2 factorial then adaptive multi-centre trial of Colchicine and IMP to improve clinical outcomes in adults with SARS CoV-2 COVID-19, hospitalised for hypoxia.

 

Trial Summary:

SARS CoV-2 (COVID-19) is highly infectious, with each case transmitting infection to between 2 to 3 other people. Approximately 15% of infected individuals will be hospitalised and 1 in 3 will require artificial ventilatory support. Up to a third of patients will have a poor prognosis with the commonest causes of death being overwhelming respiratory failure and/or cardiac failure and cardiac arrest associated with an acute viral or cytokine-induced myocarditis.

More than 69,000 individuals globally have died from COVID-19 infection already, with estimates for deaths in Australia projected up to more than 30,000 over the next 6-12 months. These final events are thought to be driven by inflammatory responses to the viral infection resulting in host-mediated tissue damage to lung and heart, with cytokine storm considered to be a penultimate event resulting in acute respiratory distress syndrome and many individuals suffering from cardiac myocarditis injury with potentially fatal arrhythmias and cardiogenic shock.

We have shown in pilot studies that oral colchicine has striking anti-inflammatory properties in patients with cardiovascular disease and a “single shot” colchicine markedly suppresses monocyte inflammasome activation. Biodegradable immunomodulatory particles trigger splenic and hepatic sequestration of activated monocytes capable of otherwise releasing potent cytokines with direct tissue damage and could reduce tissue injury by 25%, then this might improve outlook both in terms of need for intubation, and fatal outcomes of COVID-19 materially and enhance survivorship with subsequent immunity from re-infection. Troublesome side effects with both treatments appear to be rare.

Aim To evaluate the ability of both immune-modifying nanoparticles (IMP©; FDAfast- track approval; COUR Inc., USA) and low-dose anti-inflammatory colchicine treatment, alone and together, to reduce host injury to the lungs and heart and adverse outcomes in Australians hospitalised with symptomatic COVID-19 (swab-positive PCR) related infections.

Supported By:

MRFF

Eligibility:

Patients with SARS CoV2 COVID-19, who are in hospital and require oxygen support.

Registration ID:

Tbc

Participation:

Sites tbc

Australian Lead Group:

CTC

Status:

Start-up

Activation Date:

Q3 2020

Chairs:

Prof Tony Keech

Contact:

Tbc