CATALYST a randomised early phase adaptive trial for new drugs for SARS-CoV-2+ patients

  • Funded by Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Total publications:2 publications

Grant number: MC_PC_20007

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2021
  • Known Financial Commitments (USD)

    $552,150
  • Funder

    Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Principle Investigator

    Pending
  • Research Location

    United Kingdom, Europe
  • Lead Research Institution

    University of Birmingham
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Phase 2 clinical trial

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Clinical Trial, Phase II

  • Broad Policy Alignment

    Pending

  • Age Group

    Unspecified

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

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 by sequestration of virally-infected pulmonary and circulating macrophages, dendritic cells and abnormal antibody response to viral antigens, which promote an injurious, proinflammatory microenvironment. 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. The primary outcome measure, the ratio of oxygen saturation to fractional inspired oxygen concentration (SpO2/FiO2), will be modelled using Bayesian multi-level models that allow for nesting of the repeated measures data. Specifically, posterior probabilities for the treatment and treatment/time interaction covariates will be used to conduct decision making. Data will be analysed in subsets; each treatment against the control group, with modelling conducted on each dataset. Any important covariates will be incorporated accordingly into the model structure. All comparisons will be performed with regard to control arm data.

Publicationslinked via Europe PMC

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View all publications at Europe PMC

Namilumab or infliximab compared with standard of care in hospitalised patients with COVID-19 (CATALYST): a randomised, multicentre, multi-arm, multistage, open-label, adaptive, phase 2, proof-of-concept trial.

CATALYST trial protocol: a multicentre, open-label, phase II, multiarm trial for an early and accelerated evaluation of the potential treatments for COVID-19 in hospitalised adults.