Phase 2 Multi-Center Study to Evaluate Antiviral Treatments for Early Symptomatic COVID-19 in Adults Aged 18 to 60

What this Trial Is About

Researchers are evaluating antiviral treatments for adults with early symptomatic COVID-19 who have high viral loads but are at low risk of severe illness. This Phase 2 trial aims to develop and validate a way to measure how well these treatments reduce the amount of virus in the body. The study compares three types of interventionssmall molecule drugs, monoclonal antibodies, and dose adjustments for nirmatrelvirritonaviragainst a control group that receives no antiviral treatment. The trial is adaptive and is supported by the Wellcome Trust through the COVID-19 Therapeutics Accelerator. The treatments studied include various small molecule drugs like nitazoxanide, nirmatrelvirritonavir, hydroxychloroquine, atilotrelvirritonavir, metformin, and monoclonal antibodies such as sotrovimab and others as they become available. Some treatment arms have been closed after meeting stopping criteria. Participants are randomly assigned to receive one of the available antiviral drugs or no treatment, with at least 20% assigned to the control group. Dosages vary by drug and are typically administered over 5 to 7 days. Participants will be monitored closely over the first 14 days, with daily assessments of viral levels and symptoms. Researchers will measure how quickly the virus clears from the body compared to no treatment or positive control arms. Additional outcomes include fever resolution and symptom improvement. Participants must be able to walk unaided and agree to follow-up visits. The study runs until January 2027 and aims to determine optimal dosing and antiviral effectiveness in early COVID-19 infection.

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