Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) — PLATCOV  

COVID-19 Clinical Trial

Official title: Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)

Status Recruiting

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 to determine in-vivo antiviral activity. In this randomized 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: Newly available and repurposed potential antiviral drugs; B: Positive control: monoclonal antibodies initially but subsequently any therapeutic that is shown to accelerate the rate of viral clearance C: Novel small molecule drugs that have gone through phase 1 testing PLATCOV study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.

Clinical Trial Description

The platform trial will assess drugs with potential SARS-CoV-2 antiviral Activity of three general types: A. Newly available and repurposed potential antiviral drugs. (initially from: hydroxychloroquine, ivermectin, lopinavir-ritonavir, miglustat, remdesivir, nitazoxanide, nebulized unfractionated heparin (UFH), favipiravir, molnupiravir, nirmatrelvir/ritonavir (e.g. PAXLOVID™), fluoxetine, fluvoxamine, AZD7442 (EVUSHELD™),ensitrelvir, and a combination of molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVID™) Newly available and repurposed drugs are already used and recommended in some countries. Showing that they do not have significant antiviral activity is as important as showing that they do. For the newly approved antivirals, comparing antiviral activities in- vivo will inform health authorities' recommendations. B. Positive control: monoclonal antibodies initially (e.g. casirivimab/imdevimab) but subsequently any therapeutic that is shown to accelerate the rate of viral clearance 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. This will also be important for other antivirals. Monoclonal antibodies are expensive and cannot be produced at large scale currently, but this may change in the near future. These drugs may not be available early in the study, and will be included if there is local availability and regulatory approval. 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. Randomization to the no antiviral treatment control arm (no intervention) will be fixed at a minimum of 20% throughout the study. The randomization ratios will be uniform for all available interventions. Recruitment into the ivermectin arm was stopped on April 18th 2022 due to meeting the pre- defined stopping criteria. Recruitment into the remdesivir arm was stopped on June 10th 2022 due to meeting the pre- defined stopping criteria. Recruitment into the REGN-COV2 arm was stopped on October 20th 2022 due to meeting the pre-defined stopping criteria. Recruitment into the favipiravir arm was stopped on October 31st 2022 due to meeting the pre-defined stopping criteria. ;

Related Conditions & MeSH terms

• COVID-19

• NCT number: NCT05041907
• Study type: Interventional
• Source: University of Oxford
• Contact: William Schilling, MD
• Phone: +662 203 6333
• Email: william@tropmedres.ac
• Status: Recruiting
• Phase: Phase 2
• Start date: September 30, 2021
• Completion date: August 2024