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• W4362455261 abstract "We sincerely thank Zeng et al. [[1]Zeng G. Liu J. Liu S. Re: ‘efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysis’ by Deng et al.Clin Microbiol Infect. 2023; 29: 578-586https://doi.org/10.1016/j.cmi.2023.01.024Abstract Full Text Full Text PDF Scopus (0) Google Scholar] for their insightful comments. We agree with Zeng et al. [[1]Zeng G. Liu J. Liu S. Re: ‘efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysis’ by Deng et al.Clin Microbiol Infect. 2023; 29: 578-586https://doi.org/10.1016/j.cmi.2023.01.024Abstract Full Text Full Text PDF Scopus (0) Google Scholar] that factors beyond differences in fluvoxamine dose should be considered when interpreting our results. As discussed in our review, one such factor is the difference in vaccination rates between the TOGETHER trial and the newer ACTIV-6 and COVID-OUT trials [[2]Deng J. Rayner D. Ramaraju H.B. Abbas U. Garcia C. Heybati K. et al.Efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysis.Clin Microbiol Infect. 2023; 29: 578-586https://doi.org/10.1016/j.cmi.2023.01.010Abstract Full Text Full Text PDF Scopus (1) Google Scholar]. Both the ACTIV-6 and COVID-OUT trials had vaccination rates of >50% compared with a vaccination rate of <10% in the TOGETHER trial [3Reis G. Dos Santos Moreira-Silva E.A. Silva D.C.M. Thabane L. Milagres A.C. Ferreira T.S. et al.Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial.Lancet Glob Health. 2022; 10: e42-e51https://doi.org/10.1016/s2214-109x(21)00448-4Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 4McCarthy M.W. Naggie S. Boulware D.R. Lindsell C.J. Stewart T.G. Felker G.M. et al.Fluvoxamine for outpatient treatment of COVID-19: a decentralized, placebo-controlled, randomized, platform clinical trial.https://doi.org/10.1101/2022.10.17.22281178v2Date: 2022Google Scholar, 5Bramante C.T. Huling J.D. Tignanelli C.J. Buse J.B. Liebovitz D.M. Nicklas J.M. et al.Randomized trial of metformin, ivermectin, and fluvoxamine for Covid-19.N Engl J Med. 2022; 387: 599-610https://doi.org/10.1056/nejmoa2201662Crossref PubMed Scopus (0) Google Scholar]. Given that the implementation of the COVID-19 vaccination has been associated with reduced hospitalization and death following SARS-CoV-2 infections [[6]Marrone G. Nicolay N. Bundle N. Karki T. Spiteri G. Suija H. et al.Risk reduction of severe outcomes in vaccinated COVID-19 cases: an analysis of surveillance data from Estonia, Ireland, Luxembourg and Slovakia, January to November 2021.Euro Surveill. 2022; 27https://doi.org/10.2807/1560-7917.ES.2022.27.7.2200060Crossref PubMed Scopus (2) Google Scholar,[7]Moghadas S.M. Vilches T.N. Zhang K. Wells C.R. Shoukat A. Singer B.H. et al.The impact of vaccination on coronavirus disease 2019 (COVID-19) outbreaks in the United States.Clin Infect Dis. 2021; 73: 2257-2264https://doi.org/10.1093/cid/ciab079Crossref PubMed Scopus (191) Google Scholar], a higher proportion of vaccinated patients in the newer trials could diminish the protective effect of selective serotonin reuptake inhibitors (SSRIs). In addition, differences in the inclusion criteria between different SSRI trials should also be considered. For instance, the TOGETHER trial only included patients with risk factors for clinical progression, whereas the ACTIV-6 trial did not impose such a restriction [[3]Reis G. Dos Santos Moreira-Silva E.A. Silva D.C.M. Thabane L. Milagres A.C. Ferreira T.S. et al.Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial.Lancet Glob Health. 2022; 10: e42-e51https://doi.org/10.1016/s2214-109x(21)00448-4Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar,[4]McCarthy M.W. Naggie S. Boulware D.R. Lindsell C.J. Stewart T.G. Felker G.M. et al.Fluvoxamine for outpatient treatment of COVID-19: a decentralized, placebo-controlled, randomized, platform clinical trial.https://doi.org/10.1101/2022.10.17.22281178v2Date: 2022Google Scholar]. Patients who are at high risk are more prone to clinical events and thus may be more likely to benefit from SSRIs and other COVID-19 medications under investigation [[8]Agrawal U. Bedston S. McCowan C. Oke J. Patterson L. Robertson C. et al.Severe COVID-19 outcomes after full vaccination of primary schedule and initial boosters: pooled analysis of national prospective cohort studies of 30 million individuals in England, Northern Ireland, Scotland, and Wales.Lancet. 2022; 400: 1305-1320https://doi.org/10.1016/S0140-6736(22)01656-7Abstract Full Text Full Text PDF PubMed Scopus (26) Google Scholar]. Similarly, the STOP COVID 2 trial—which did not limit its inclusion criteria to patients who were at high risk—also observed a lack of clinical events and treatment effects despite using a higher dose of fluvoxamine than that used in ACTIV-6 trial, resulting in its premature termination [[9]Lee T.C. Vigod S. Bortolussi-Courval É. Hanula R. Boulware D.R. Lenze E.J. et al.Fluvoxamine for outpatient management of COVID-19 to prevent hospitalization: a systematic review and meta-analysis.JAMA Netw Open. 2022; 5e226269https://doi.org/10.1001/jamanetworkopen.2022.6269Crossref Scopus (31) Google Scholar,[10]Fluvoxamine for early treatment of Covid-19.https://clinicaltrials.gov/ct2/show/NCT04668950Google Scholar]. On the other hand, the COVID-OUT trial did not observe any significant benefits associated with the same fluvoxamine regimen used in the ACTIV-6 trial, despite enrolling high-risk patients who were overweight or living with obesity [[5]Bramante C.T. Huling J.D. Tignanelli C.J. Buse J.B. Liebovitz D.M. Nicklas J.M. et al.Randomized trial of metformin, ivermectin, and fluvoxamine for Covid-19.N Engl J Med. 2022; 387: 599-610https://doi.org/10.1056/nejmoa2201662Crossref PubMed Scopus (0) Google Scholar]. Based on these findings, both dosage and patient characteristics may affect the protective effects of SSRIs. As stated in our review, we maintain the view that future COVID-19 trials should be limited to patients at risk for deterioration who are more likely to benefit from intervention medications. As Zeng et al. [[1]Zeng G. Liu J. Liu S. Re: ‘efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysis’ by Deng et al.Clin Microbiol Infect. 2023; 29: 578-586https://doi.org/10.1016/j.cmi.2023.01.024Abstract Full Text Full Text PDF Scopus (0) Google Scholar] mentioned, similar approaches have already been adopted in clinical trials assessing other COVID-19 medications, such as the EPIC-SR trial assessing nirmatrelvir/ritonavir, which stopped its enrolment in standard-risk patients [[11]Pfizer Media RelationsPfizer reports additional data on PAXLOVIDTM supporting upcoming new drug application submission to. U.S. FDA. Pfizer Press Release, 2022https://www.pfizer.com/news/press-release/press-release-detail/pfizer-reports-additional-data-paxlovidtm-supportingGoogle Scholar,[12]PfizerEvaluation of protease inhibition for COVID-19 in standard-risk patients (EPIC-SR).https://clinicaltrials.gov/ct2/show/NCT05011513Google Scholar]. We agree with Zeng et al. [[1]Zeng G. Liu J. Liu S. Re: ‘efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysis’ by Deng et al.Clin Microbiol Infect. 2023; 29: 578-586https://doi.org/10.1016/j.cmi.2023.01.024Abstract Full Text Full Text PDF Scopus (0) Google Scholar] that further investigations are needed to elucidate the protective effects of SSRIs. We look forward to results from upcoming investigations, including the Fluvoxamine 100 arm of the ACTIV-6 platform trial, which recently completed its patient enrolment process. This new data should shed more light on whether the differences in our observed treatment effects are attributable to dosing regimens and/or other factors. J.D., C.G., K.H., and F.Z. conceptualized the main points within this letter. J.D. and E.A. were involved in the research and drafting process. C.G., K.H., and F.Z. made critical revisions to the letter. The authors declare that they have no conflicts of interest. The authors did not receive any funding for the completion of this letter. Re: ‘efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysis’ by Deng et al.Clinical Microbiology and InfectionVol. 29Issue 6PreviewDeng et al. [1] conducted a systematic review and meta-analysis to evaluate the efficacy and safety of fluvoxamine in the management of patients with COVID-19. Their study found that medium-dose fluvoxamine was associated with reduced mortality, hospitalization, and emergency room visits. Therefore, they suggested that the differences in the results of clinical trials may be related to the different dosing regimens used in randomized controlled trials (RCTs), with higher doses of fluvoxamine used in earlier RCTs compared with those used in recent RCTs. Full-Text PDF Efficacy and safety of selective serotonin reuptake inhibitors in COVID-19 management: a systematic review and meta-analysisClinical Microbiology and InfectionVol. 29Issue 5PreviewThe efficacy of selective serotonin reuptake inhibitors (SSRIs) in the treatment of acute COVID-19 is still under investigation, with conflicting results reported from randomized controlled trials (RCTs). Different dosing regimens may have contributed to the contradictory findings. Full-Text PDF" @default.
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