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:29 publications
Grant number: MC_PC_19056
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Key facts
Disease
COVID-19Start & end year
20202021Known Financial Commitments (USD)
$2,699,935.59Funder
Department of Health and Social Care / National Institute for Health and Care Research (DHSC-NIHR), UK Research and Innovation (UKRI)Principal Investigator
PendingResearch Location
ChinaLead Research Institution
University of OxfordResearch Priority Alignment
N/A
Research Category
Therapeutics research, development and implementation
Research Subcategory
Prophylactic use of treatments
Special Interest Tags
N/A
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.
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