COVID-19: multi-arm, multi stage adaptive clinical trial (CoV-MAMS)

  • Funded by Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)
  • Total publications:28 publications

Grant number: MC_PC_19056

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2020
    2021
  • Known Financial Commitments (USD)

    $2,699,935.59
  • 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

    China, Europe
  • Lead Research Institution

    University of Oxford
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Prophylactic use of treatments

  • Special Interest Tags

    Gender

  • Study Subject

    Clinical

  • Clinical Trial Details

    Clinical Trial, Phase II

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Unspecified

  • Occupations of Interest

    Unspecified

Abstract

This COVID-19 Rapid Response award is jointly funded (50:50) between the Medical Research Council and the National Institute for Health Research. The figure displayed is the total award amount of the two funders combined, with each partner contributing equally towards the project. Medicines to prevent and effectively treat 2019 coronavirus disease (COVID-19), especially severe lower respiratory tract (LRT) illness, would save lives and reduce healthcare pressures. Randomised controlled trials (RCTs) are ongoing in China of lopinavir/ritonavir [ChiCTR2000029308] and remdesivir [NCT04257656 and NCT04252664]. Additional potential therapeutics are being considered by the WHO. Building on our existing experience and capabilities, we are proposing to implement a multi-arm, multi-stage (MAMS) RCT. This trial will be designed to evaluate up to four experimental therapeutics in a flexible, adaptive framework. MAMS designs have been shown to be more efficient than sequential RCTs or factorial designs. The trial will enrol patients hospitalised with laboratory confirmed COVID-19. Patients will initially be randomised equally to receive one of up to 4 active treatments or control. Should not all active arms be available at study onset, patients will be randomized between available active arms and control. The trial will commence with two active arms, lopinavir/ritonavir and low dose dexamethasone. Additional active arms will be added as data and drug availability allow.

Publicationslinked via Europe PMC

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View all publications at Europe PMC

Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Correction to Lancet Diabetes Endocrinol 2023; 11: 905-14.

Empagliflozin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.

Chemically defined cytokine-free expansion of human haematopoietic stem cells.

Facilitating participation in clinical trials during pregnancy.

Baricitinib in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial and updated meta-analysis.

Janus kinase inhibitors for the treatment of COVID-19.

Why preprints are good for patients.

Casirivimab and imdevimab in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial.