Active Infection & Immunity

A phase 2 multi-centre adaptive platform trial to assess antiviral pharmacodynamics in COVID-19 (PLATCOV)

In plain English

AI plain-English summary

A single clinical trial in Thailand, Brazil, Pakistan, Laos, and an African site is now systematically measuring which antiviral drugs actually clear COVID-19 from the body—and which do nothing at all. During a pandemic, doctors and policymakers need fast, reliable answers about which treatments work. Most COVID-19 drug trials compared a drug to placebo, but that tells you nothing about how one drug stacks up against another. PLATCOV solves this by using a standardised method: it measures the rate at which the virus disappears from a patient’s throat over seven days, then compares each drug’s effect to a no-drug control. The trial has already shown that ivermectin has no effect, while remdesivir accelerates viral clearance by 42%, and the monoclonal antibody combination casivirimab/imdevimab sped clearance by 60% against the Delta variant. If this platform continues, it will provide definitive head-to-head comparisons of new antivirals and monoclonal antibodies for COVID-19, and begin doing the same for influenza. The result is a global, standardised system for rapidly assessing treatments during future respiratory pandemics—replacing guesswork with hard pharmacometric data that can guide clinical decisions in real time.

View original technical description
PLATCOV is an ongoing phase 2, open label, randomised, controlled adaptive platform trial. It is unique in providing a standardised quantitative comparative method for in vivo assessment of potential antiviral treatments in low-risk adults with early symptomatic COVID-19. The primary outcome is the rate of viral clearance measured as the slope of the log10 oropharyngeal viral clearance curve over the first 7 days following randomisation. The treatment effect is the multiplicative change in viral clearance rate relative to the no study drug arm. PLATCOV has recruited over 550 patients and provided definitive assessments of ivermectin (no effect), remdesivir (42% acceleration in viral clearance), casivirimab/imdevimab (60% acceleration in Delta, and approximately 20% acceleration in Omicron BA.2 and BA.5). This proposal is to continue PLATCOV in order to assess new antiviral drugs and monoclonal antibodies and combinations, to extend to five study sites across the world (continue in Thailand and Brazil, add Pakistan, Laos and an African site), and to conduct preliminary evaluations of a similar pharmacometric design to assess anti-influenza drugs. The final objective is definitive assessments of comparative antiviral effects in COVID-19, and initial establishment of a global platform for pharmacometric assessment of interventions in pandemic respiratory infections.

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Researchers

James Watson (EPMC Awardee)Mauro Teixeira (EPMC Awardee)Mohammed Asim Beg (EPMC Awardee)Podjanee Jittamala (EPMC Awardee)William Schilling (EPMC Awardee)

Related Research

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Discretionary Award

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