Finding treatments for COVID-19: A phase 2 multi-centre adaptive platform trial to assess antiviral pharmacodynamics in early symptomatic COVID-19 (PLAT-COV)
- Funded by Wellcome Trust
- Total publications:21 publications
Grant number: 223195/Z/21/Z
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Key facts
Disease
COVID-19Start & end year
20212023Known Financial Commitments (USD)
$5,088,336.86Funder
Wellcome TrustPrincipal Investigator
Prof Sir Nicholas WhiteResearch Location
United KingdomLead Research Institution
University of OxfordResearch Priority Alignment
N/A
Research Category
Therapeutics research, development and implementationResearch Subcategory
Clinical trial (unspecified trial phase)Special Interest Tags
N/AStudy Type
ClinicalClinical Trial Details
Randomized Controlled TrialBroad Policy Alignment
PendingAge Group
Adults (18 and older)Vulnerable Population
UnspecifiedOccupations of Interest
Unspecified
Abstract
We propose to set up and validate a pharmacometric platform to provide quantitative assessment of antiviral effects in low risk adult patients with recent onset uncomplicated COVID-19 and high viral burdens. This assessment is based on measurement of oropharyngeal viral clearance rates. This will be a randomised, open label, group sequential adaptive platform trial to quantitate the antiviral activity of currently available potential (i.e. repurposed) treatments in low-risk adult patients with early COVID-19, through adjusted qPCR of serial oropharyngeal samples. It will be a mainly outpatient study conducted in three locations; one each in the Americas, Europe and Asia. The interventions to be evaluated in this first phase are hydroxychloroquine, lopinavir/ritonavir, ivermectin, miglustat, remdesivir, intranasal heparin, with the Regeneron monoclonal antibody cocktail or Peginterferon-lambda as a positive control. This will identify drugs with a > 90% probability of accelerating virus clearance compared to no treatment and will reject drugs with
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