Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context
Summary: Background: The selective serotonin reuptake inhibitors (SSRIs) fluoxetine and fluvoxamine were repurposed for the treatment of early COVID-19 based on their antiviral activity in vitro, and observational and clinical trial evidence suggesting they prevented progression to severe disease....
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Elsevier
2025-02-01
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| author | Podjanee Jittamala Simon Boyd William H.K. Schilling James A. Watson Thundon Ngamprasertchai Tanaya Siripoon Viravarn Luvira Elizabeth M. Batty Phrutsamon Wongnak Lisia M. Esper Pedro J. Almeida Cintia Cruz Fernando R. Ascencao Renato S. Aguiar Najia K. Ghanchi James J. Callery Shivani Singh Varaporn Kruabkontho Thatsanun Ngernseng Jaruwan Tubprasert Wanassanan Madmanee Kanokon Suwannasin Amornrat Promsongsil Borimas Hanboonkunupakarn Kittiyod Poovorawan Manus Potaporn Attasit Srisubat Bootsakorn Loharjun Walter R.J. Taylor Farah Qamar Abdul Momin Kazi M. Asim Beg Danoy Chommanam Sisouphanh Vidhamaly Kesinee Chotivanich Mallika Imwong Sasithon Pukrittayakamee Arjen M. Dondorp Nicholas P.J. Day Mauro M. Teixeira Watcharapong Piyaphanee Weerapong Phumratanaprapin Nicholas J. White |
| author_facet | Podjanee Jittamala Simon Boyd William H.K. Schilling James A. Watson Thundon Ngamprasertchai Tanaya Siripoon Viravarn Luvira Elizabeth M. Batty Phrutsamon Wongnak Lisia M. Esper Pedro J. Almeida Cintia Cruz Fernando R. Ascencao Renato S. Aguiar Najia K. Ghanchi James J. Callery Shivani Singh Varaporn Kruabkontho Thatsanun Ngernseng Jaruwan Tubprasert Wanassanan Madmanee Kanokon Suwannasin Amornrat Promsongsil Borimas Hanboonkunupakarn Kittiyod Poovorawan Manus Potaporn Attasit Srisubat Bootsakorn Loharjun Walter R.J. Taylor Farah Qamar Abdul Momin Kazi M. Asim Beg Danoy Chommanam Sisouphanh Vidhamaly Kesinee Chotivanich Mallika Imwong Sasithon Pukrittayakamee Arjen M. Dondorp Nicholas P.J. Day Mauro M. Teixeira Watcharapong Piyaphanee Weerapong Phumratanaprapin Nicholas J. White |
| author_sort | Podjanee Jittamala |
| collection | DOAJ |
| description | Summary: Background: The selective serotonin reuptake inhibitors (SSRIs) fluoxetine and fluvoxamine were repurposed for the treatment of early COVID-19 based on their antiviral activity in vitro, and observational and clinical trial evidence suggesting they prevented progression to severe disease. However, these SSRIs have not been recommended in therapeutic guidelines and their antiviral activity in vivo has not been characterised. Methods: PLATCOV is an open-label, multicentre, phase 2, randomised, controlled, adaptive pharmacometric platform trial running in Thailand, Brazil, Pakistan, and Laos. We recruited low-risk adult outpatients aged 18–50 with early symptomatic COVID-19 (symptoms <4 days) between 5 April 2022 and 8 May 2023. Patients were assigned using block randomisation to one of eleven treatment arms including oral fluoxetine (40 mg/day for 7 days), or no study drug. Uniform randomisation ratios were applied across the active treatment groups while the no study drug group comprised ≥20% of patients at all times. The primary endpoint was the rate of oropharyngeal viral clearance assessed until day 7. Measurements were taken daily between days 0 and 7 and analysed in a modified intention-to-treat population (>2 days follow-up).The viral clearance rate was estimated under a Bayesian hierarchical linear model fitted to the log10 viral densities measured in standardised duplicate oropharyngeal swab eluates taken daily over one week (18 measurements per patient). Secondary endpoints were all-cause hospital admission at 28 days, and time to resolution of fever and symptoms. This ongoing trial is registered at ClinicalTrials.gov (NCT05041907). Findings: 271 patients were concurrently randomised to either fluoxetine (n = 120) or no study drug (n = 151). All patients had received at least one COVID-19 vaccine dose and 67% were female (182/271). In the primary analysis, viral clearance rates following fluoxetine were compatible with a small or no increase relative to the no study drug arm (15% increase; 95% credible interval (CrI): −2 to 34%). There were no deaths or hospitalisations in either arm. There were no significant differences in times to symptom resolution or fever clearance between the fluoxetine and the no study drug arms (although only a quarter of patients were febrile at baseline). Fluoxetine was well tolerated, there were no serious adverse events and only one grade 3 adverse event in the intervention arm. Interpretation: Overall, the evidence from this study is compatible with fluoxetine having a weak in vivo antiviral activity against SARS-CoV-2, although the primary endpoint is also compatible with no effect. This level of antiviral efficacy is substantially less than with other currently available antiviral drugs. Funding: Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator. |
| format | Article |
| id | doaj-art-33d23012bc4e4d308392df604b2978ba |
| institution | Kabale University |
| issn | 2589-5370 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj-art-33d23012bc4e4d308392df604b2978ba2025-01-20T04:17:49ZengElsevierEClinicalMedicine2589-53702025-02-0180103036Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in contextPodjanee Jittamala0Simon Boyd1William H.K. Schilling2James A. Watson3Thundon Ngamprasertchai4Tanaya Siripoon5Viravarn Luvira6Elizabeth M. Batty7Phrutsamon Wongnak8Lisia M. Esper9Pedro J. Almeida10Cintia Cruz11Fernando R. Ascencao12Renato S. Aguiar13Najia K. Ghanchi14James J. Callery15Shivani Singh16Varaporn Kruabkontho17Thatsanun Ngernseng18Jaruwan Tubprasert19Wanassanan Madmanee20Kanokon Suwannasin21Amornrat Promsongsil22Borimas Hanboonkunupakarn23Kittiyod Poovorawan24Manus Potaporn25Attasit Srisubat26Bootsakorn Loharjun27Walter R.J. Taylor28Farah Qamar29Abdul Momin Kazi30M. Asim Beg31Danoy Chommanam32Sisouphanh Vidhamaly33Kesinee Chotivanich34Mallika Imwong35Sasithon Pukrittayakamee36Arjen M. Dondorp37Nicholas P.J. Day38Mauro M. Teixeira39Watcharapong Piyaphanee40Weerapong Phumratanaprapin41Nicholas J. White42Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK; Corresponding author. Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok, 10400, Thailand.Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK; Infectious Diseases Data Observatory, Big Data Institute, Oxford, United KingdomDepartment of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandDepartment of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandDepartment of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandClinical Research Unit, Center for Advanced and Innovative Therapies, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilClinical Research Unit, Center for Advanced and Innovative Therapies, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandDepartment of Biochemistry and Immunology, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilDepartment of Genetics, Ecology and Evolution, Institute of Biological Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilAga Khan University, Karachi, PakistanMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandDepartment of Medical Services, Ministry of Public Health, Bangkok, ThailandDepartment of Medical Services, Ministry of Public Health, Bangkok, ThailandDepartment of Medical Services, Ministry of Public Health, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKAga Khan University, Karachi, PakistanAga Khan University, Karachi, PakistanAga Khan University, Karachi, PakistanLaos-Oxford-Mahosot Hospital-Wellcome Trust Research Unit, Microbiology Laboratory, Mahosot Hospital, Vientiane, LaosPulmonology Department, Mahosot Hospital, Vientiane, LaosMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Molecular Tropical Medicine and Genetics, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UKClinical Research Unit, Center for Advanced and Innovative Therapies, Universidade Federal de Minas Gerais, Belo Horizonte, BrazilDepartment of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandDepartment of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, ThailandMahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK; Corresponding author. Mahidol Oxford Tropical Medicine Research Unit, Faculty of Tropical Medicine, Mahidol University, 420/6 Rajvithi Rd, Bangkok, 10400, Thailand.Summary: Background: The selective serotonin reuptake inhibitors (SSRIs) fluoxetine and fluvoxamine were repurposed for the treatment of early COVID-19 based on their antiviral activity in vitro, and observational and clinical trial evidence suggesting they prevented progression to severe disease. However, these SSRIs have not been recommended in therapeutic guidelines and their antiviral activity in vivo has not been characterised. Methods: PLATCOV is an open-label, multicentre, phase 2, randomised, controlled, adaptive pharmacometric platform trial running in Thailand, Brazil, Pakistan, and Laos. We recruited low-risk adult outpatients aged 18–50 with early symptomatic COVID-19 (symptoms <4 days) between 5 April 2022 and 8 May 2023. Patients were assigned using block randomisation to one of eleven treatment arms including oral fluoxetine (40 mg/day for 7 days), or no study drug. Uniform randomisation ratios were applied across the active treatment groups while the no study drug group comprised ≥20% of patients at all times. The primary endpoint was the rate of oropharyngeal viral clearance assessed until day 7. Measurements were taken daily between days 0 and 7 and analysed in a modified intention-to-treat population (>2 days follow-up).The viral clearance rate was estimated under a Bayesian hierarchical linear model fitted to the log10 viral densities measured in standardised duplicate oropharyngeal swab eluates taken daily over one week (18 measurements per patient). Secondary endpoints were all-cause hospital admission at 28 days, and time to resolution of fever and symptoms. This ongoing trial is registered at ClinicalTrials.gov (NCT05041907). Findings: 271 patients were concurrently randomised to either fluoxetine (n = 120) or no study drug (n = 151). All patients had received at least one COVID-19 vaccine dose and 67% were female (182/271). In the primary analysis, viral clearance rates following fluoxetine were compatible with a small or no increase relative to the no study drug arm (15% increase; 95% credible interval (CrI): −2 to 34%). There were no deaths or hospitalisations in either arm. There were no significant differences in times to symptom resolution or fever clearance between the fluoxetine and the no study drug arms (although only a quarter of patients were febrile at baseline). Fluoxetine was well tolerated, there were no serious adverse events and only one grade 3 adverse event in the intervention arm. Interpretation: Overall, the evidence from this study is compatible with fluoxetine having a weak in vivo antiviral activity against SARS-CoV-2, although the primary endpoint is also compatible with no effect. This level of antiviral efficacy is substantially less than with other currently available antiviral drugs. Funding: Wellcome Trust Grant ref: 223195/Z/21/Z through the COVID-19 Therapeutics Accelerator.http://www.sciencedirect.com/science/article/pii/S2589537024006151SARS-CoV-2AntiviralsCOVID-19Viral clearance |
| spellingShingle | Podjanee Jittamala Simon Boyd William H.K. Schilling James A. Watson Thundon Ngamprasertchai Tanaya Siripoon Viravarn Luvira Elizabeth M. Batty Phrutsamon Wongnak Lisia M. Esper Pedro J. Almeida Cintia Cruz Fernando R. Ascencao Renato S. Aguiar Najia K. Ghanchi James J. Callery Shivani Singh Varaporn Kruabkontho Thatsanun Ngernseng Jaruwan Tubprasert Wanassanan Madmanee Kanokon Suwannasin Amornrat Promsongsil Borimas Hanboonkunupakarn Kittiyod Poovorawan Manus Potaporn Attasit Srisubat Bootsakorn Loharjun Walter R.J. Taylor Farah Qamar Abdul Momin Kazi M. Asim Beg Danoy Chommanam Sisouphanh Vidhamaly Kesinee Chotivanich Mallika Imwong Sasithon Pukrittayakamee Arjen M. Dondorp Nicholas P.J. Day Mauro M. Teixeira Watcharapong Piyaphanee Weerapong Phumratanaprapin Nicholas J. White Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context EClinicalMedicine SARS-CoV-2 Antivirals COVID-19 Viral clearance |
| title | Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context |
| title_full | Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context |
| title_fullStr | Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context |
| title_full_unstemmed | Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context |
| title_short | Antiviral efficacy of fluoxetine in early symptomatic COVID-19: an open-label, randomised, controlled, adaptive platform trial (PLATCOV)Research in context |
| title_sort | antiviral efficacy of fluoxetine in early symptomatic covid 19 an open label randomised controlled adaptive platform trial platcov research in context |
| topic | SARS-CoV-2 Antivirals COVID-19 Viral clearance |
| url | http://www.sciencedirect.com/science/article/pii/S2589537024006151 |
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