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Finding treatments for COVID-19: A phase 2 multi-centre adaptive platform trial to assess antiviral pharmacodynamics in early symptomatic COVID-19 (PLAT-COV)

Grant number: 223195/Z/21/Z

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Key facts

  • Disease

    COVID-19
  • Start & end year

    2021
    2023
  • Known Financial Commitments (USD)

    $5,088,336.86
  • Funder

    Wellcome Trust
  • Principal Investigator

    Prof Sir Nicholas White
  • Research Location

    United Kingdom
  • Lead Research Institution

    University of Oxford
  • Research Priority Alignment

    N/A
  • Research Category

    Therapeutics research, development and implementation

  • Research Subcategory

    Clinical trial (unspecified trial phase)

  • Special Interest Tags

    N/A

  • Study Type

    Clinical

  • Clinical Trial Details

    Randomized Controlled Trial

  • Broad Policy Alignment

    Pending

  • Age Group

    Adults (18 and older)

  • Vulnerable Population

    Unspecified

  • Occupations 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

21 Publications linked via Europe PMC

Characterizing viral clearance kinetics in acute influenza.

Accurate Measurement of Viral Clearance in Early-Phase Antiviral Studies in Coronavirus Disease 2019.

Correction to Lancet Infect Dis 2025; published online Oct 10. https://doi.org/10.1016/S1473-3099(25)00482-7.

Antiviral efficacy of oral ensitrelvir versus oral ritonavir-boosted nirmatrelvir in COVID-19 (PLATCOV): an open-label, phase 2, randomised, controlled, adaptive trial.

Assessing monoclonal antibodies for respiratory virus infections.

Characterising viral clearance kinetics in acute influenza

A comparison of national seasonal influenza treatment guidelines across the Asia Pacific region.

Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV).

Evidence that remdesivir treatment reduces viral titers in patients with COVID-19.