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MORU/LOMWRU. Photographer: Latsaniphone Soutthasavong.
After recruiting 240 low-risk adult patients with early symptomatic COVID-19 to the multicentre open-label, randomised, controlled, adaptive PLATCOV platform trial, the Mahidol Oxford Tropical Medicine Research Unit (MORU) researchers gave Favipiravir to 114 randomly selected patients and no study drug to 126 randomised patients. They found no difference in the rate of viral clearance between patients given Favipiravir and patients receiving no study drug.
“This study reinforces the important principle that before an anti-infective drug is recommended for general use its activity needs to be evaluated in patients as well as in the laboratory,” said study co-Principal Investigator (PI) Prof Sir Nick White, based at MORU, in Bangkok.
“Favipiravir, an anti-influenza drug, has activity against the SARS-CoV-2 virus in the laboratory, and has been recommended for the treatment of COVID-19 in some countries – but our study showed that Favipiravir provides no benefit in treating early COVID-19 infection,” said Prof White.
The Mahidol-based University of Oxford affiliated researchers developed a simple method of quickly assessing the antiviral activity of COVID drugs in people with mild infections based on frequent measurements of the amount of virus at the back of the mouth.
In 2021, funded by the Wellcome Trust (UK), they started PLATCOV – a series of studies to determine the efficacy of antiviral drugs that were being used to treat COVID-19 infections.
“Favipiravir was recommended for the treatment of uncomplicated COVID-19 in several countries including Japan, Russia, Saudi Arabia, Turkey, Hungary, Kenya and Thailand. The study underlines the need for clinical trial evidence to determine if there is really a benefit. In some cases, there were effective alternative treatments available. Belatedly developing this evidence on the effectiveness of drugs which were used in the COVID pandemic, and the optimal way to assess them, will, we hope, prove beneficial in the future,” said Dr William Schilling, study co-PI and a University of Oxford DPhil student based at MORU in Bangkok.
The PLATCOV testing method sets the stage for future rapid comparisons of antiviral drugs for COVID and other viral infections such as influenza.
“The PLATCOV platform is a simple, well tolerated method of comparing antiviral drugs in patients with mild infections. It provides critical information on antiviral activity. COVID-19 is still common – and large clinical trials are expensive and take time. We cannot be sure that COVID will not become serious again, so we need methods of comparing medicines rapidly to inform treatment guidelines,” said Dr Podjanee Jittamala, author of the paper and Research Physician in MORU’s Clinical Therapeutic Unit (CTU).
Paper
Clinical antiviral efficacy of favipiravir in early COVID-19 (PLATCOV): an open-label, randomised, controlled, adaptive platform trial. Luvira V, Schilling WHK, Jittamala P, Watson JA, Boyd S, Siripoon T, Ngamprasertchai T, Almeida PJ, Ekkapongpisit M, Cruz C, Callery JJ, Singh S, Tuntipaiboontana R, Kruabkontho V, Ngernseng T, Tubprasert J, Abdad MY, Keayarsa S, Madmanee W, Aguiar RS, Santos FM, Hanboonkunupakarn P, Hanboonkunupakarn B, Poovorawan K, Imwong M, Taylor WRJ, Chotivanich V, Chotivanich K, Pukrittayakamee S, Dondorp AM, Day NPJ, Teixeira MM, Piyaphanee W, Phumratanaprapin W, White NJon behalf of the PLATCOV Collaborative Group. BMC Infect Dis 24, 89 (2024). https://doi.org/10.1186/s12879-023-08835-3