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Clinical Trial Summary

The trial will develop and validate a platform for quantitative assessment of antiviral effects in low-risk patients with high viral burdens and uncomplicated COVID-19. In this randomised open label, controlled, group sequential adaptive platform trial, we will assess the performance of three distinct types of intervention relative to control (no treatment): A: potentially effective repurposed antiviral drugs; B: Positive control: we will initially include the REGN-COV2 (monoclonal antibody cocktail); and later: C: any future small molecule drugs that pass phase 1 testing. PLATCOV study is funded by ACT-Accelerator Therapeutics Partnership through the Wellcome Trust. The grant reference number is 223195/Z/21/Z

Clinical Trial Description

The platform trial will assess drugs with potential SARS-CoV-2 antiviral activity of three general types: A. Repurposed potential antiviral drugs (initially from: hydroxychloroquine, ivermectin, lopinavir-ritonavir, miglustat, remdesivir, nitazoxanide, nebulised unfractionated heparin (UFH), favipiravir) Repurposed drugs are already recommended in some countries. Showing that they do not have a significant antiviral activity is as important as showing that they do. B. Positive control: monoclonal antibody initially Monoclonal antibodies are vulnerable to viral escape mutations. Tracking their performance over time is important to characterise the impact and inform the therapeutics of mutant SARS-CoV-2 strains. Monoclonal antibodies are expensive and cannot be produced at large scale currently, but this may change in the near future. C. Novel small molecule drugs that have gone through phase 1 testing Each site will include a negative control arm consisting of patients not receiving any study drug except for antipyretics- paracetamol. At any given time in the study, it is possible that not all intervention arms are available. Randomisation ratios will be uniform across all available treatment arms of type A and B and the control arm in each site. Once interventions of type C (novel drugs) are added to the platform, response adaptive randomisation will apply ("pick the winner"). ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05041907
Study type Interventional
Source University of Oxford
Contact William Schilling, MD
Phone +662 203 6333
Email [email protected]
Status Recruiting
Phase Phase 2
Start date September 30, 2021
Completion date August 2023

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