Study Detail

CATALYST

A randomised phase II proof of principle multi-arm multi-stage trial designed to guide the selection of interventions for phase III trials in hospitalised patients with COVID-19 infection

Status: Open

Type: Interventional

Funder: not available

Sponsor: University of Birmingham

CI: Dr Tonny Veenith

IRAS-Number: 282431

CPMS-ID: 45648

Approval Date: 11 May 2020

Summary:

CATALYST is a clinical trial where participants will be randomly allocated to one of several possible new treatments for COVID-19. It will enrol patients admitted to hospital with COVID-19 associated pneumonia. The aim is to rapidly assess these new treatments in small numbers of patients, enabling the most promising therapies to be taken forward for evaluation in much larger trials. The primary means to assess these therapies will be to look for early changes in how much additional oxygen the patient needs to be given in relation to the oxygen levels in their blood. The study will also assess the clinical progress that the patient makes following treatment. The initial therapies in the trial will target the excessive and damaging levels of inflammation that are triggered by infection with the virus that causes COVID-19.

Description:

CATALYST is a randomised, open-label, multi-arm, adaptive, phase II trial to assess the potential efficacy of drugs in the early phase setting, rapidly determining which new therapies should be considered for larger-scale testing within ongoing national phase III platform trials. SARS-CoV-2 virus can cause severe pneumonia and multi-organ failure. An important contributor to severity seems to be over-activation of parts of the immune system including a type of immune cell known as macrophages, resulting in a 'cytokine storm'. Licensed and novel drugs are now available with potential to target this harmful proinflammatory response and/or directly act as antivirals, allowing a healthy adaptive immunity to emerge to suppress the viral infection and reduce viral replication respectively. CATALYST will identify candidate drugs which limit the resulting tissue damage, modify the course of the disease and improve outcomes for patients hospitalised with COVID-19.

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