Finding Treatments for COVID-19: A Phase 2 Multi-centre Adaptive Platform Trial to Assess Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
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: Small molecule drugs; B: Monoclonal antibodies; C: Dose finding for the constituent parts of nirmatrelvir/ritonavir PLATCOV study is supported by the Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.
• Patient understands the procedures and requirements and is willing and able to give informed consent for full participation in the study.
• Previously healthy adults, male or female, aged 18 to 60 years at time of consent with early symptomatic COVID-19
• SARS-CoV-2 positive by lateral flow antigen test OR a positive PCR test for SARS-CoV-2 within the last 24hrs with a Ct value of less than 25 (all viral targets)
• Symptoms of COVID-19 (including fever, or history of fever) for less than 4 days (96 hours).
• Oxygen saturation ≥96% measured by pulse-oximetry at time of screening.
• Able to walk unaided and unimpeded in ADLs
• Agrees and is able to adhere to all study procedures, including availability and contact information for follow-up visits