biostudies-literatureStewart TGNIDDK NIH HHS2354-2363https://www.ebi.ac.uk/biostudies/studies/S-EPMC10656670biostudies-literatureUnknown330(24)<h4>Importance</h4>The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.<h4>Objective</h4>To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.<h4>Design, setting, and participants</h4>The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less.<h4>Interventions</h4>Participants were randomized to receive fluvoxamine, 50 mJAMAHigher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial.PMC10656670K23 DK124654Mamon AJacklin KSexton CPillai RKhetpal SBrehaut SOragwu CCastex JFortt TSoileau BTSloan OJazayeri YManis EMankowski KCarrillo GMorales Castillo LPatel PCantu LReyes LFortt ADockery MWoods AManning BLuis Garcia JBianchi RDockery SSingleton DJames VDe La Cruz MThicklin FYuan YAdhami EAamodt DKarawan GBallmajo MVogel CAbdelsayed DNaquiallah DGutierrez APatel YAccelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV)-6 Study Group and InvestigatorsPatel VMichelson ESeithel MMcAdams MPKoppinger NVecchiarelli AMotel VFisher LGeorge-Adebayo CKlicka KWilliams TQuintero ADedier JCampora PPrabhu RHarrington AQuintero OKariyawasam DJuma MRoche AAverett ASummers JPremas JLima SJones CPyram-Bernard NMerkel ARivon MLindblom KLopez IHarper AMiller DBaez JWaite KMiller CGarcia Del Sol ITSlandzicki AHurst TTurner TWhite BRamin SShahamatdar SPangburn HHicks MDixon SPanaccione EGrimes CZSulkowski MVincent RGould CHarrell FLambert AADeComarmond MHeavlin HPullen MPrieto SBarbera ACohen JVaidya-Tank BMattox BRao SMehta MBowman JVance MGriffin AWells KHallowell CShirey-Rice JArcher ACardona OQGupta ASekikawa APardue VSamraj JEvans KVandeWeerd CGriffin MGupta MKhizer SFraser RPatterson TFOkulicz JFarlow BLi JChen JLinn DGarcia MUmana UUmana VLozinski GGnoni MLamb DGinde AAOstrosky-Zeichner LPerez Landabur ROHeidish RSMaria JAdeyemi OCienki JLai JArnold JLim STorress DGrady CAdam SJJordan JScott JParihar PRaymond OVincent WKMorris MUrbat CRebolledo PABoulware DRMarta MNielsen LPrato NHassanien GPathak DVasquez MWatts SDaugherty HSommers STan HNCollins SLenert LAHernandez AFStelmash LMartin DOrozco DAlicic RRowland TPowers-Fletcher MSappington EMcTigue KJacques GO'Donnell ACherukuri VStout EBurns ADeAlmeida SSouthwell AJackson PEHCollins JBacallao NSzwast EIsache CShah NCastro MWilson JMoy JVergara LOfotokun IWeeks KBaxter JWiley HOguego NKerr BZhang CMartin RAchong ARamirez AMAbdulghani AAziz MBozant EGentile NChan ASwink WFlys TWallan JDel Pilar AMunoz SGhaly EMaldonado MCallaghan-Brown AWeir MDuran BNwosu SMcCarthy MWRonan TWills WOyelakin MArmas ESpangler ASzeto JJones-Ince IAlleyne CDeLong ABurruss VSamir YVasbinder ABrounce GDolor RSeagle HLove NTragus RManresa IHerbert AMourad AFelker GMJayaweera DPazier PMarlin JParra DD'Andrea MOlofintuyi ACurtis CSpees RVasoya PAdams MRivera EGarcia Del Sol IWilder RRoberts MNataraj JEllison LBhat NObregon SMarcus JClement JGallegos CRohde MGabriel AAdebayo AWang JVail JArena JAmon ASevier MWatson CGoyal PPaudel DCordero-Loperena DHanna GJSingh ULiao VZapatero JBramante CTFeliciano PMeltzer AStewart TGNaggie SAdkins RRichwine RGao YMukunzi SWilliamson JCChopp JSchwasinger-Schmidt TLightfeather AKrishna AStone ARodriguez LKlawson EDunsmore SEMilstone ASmith VEMichal MWard MLindsell CJGaytan-Alvarez DAst ACornejo AChi WNMorton-Jost MDing XRuiz-Unger JGamboa Jackman JHaughey HMRogers MNowell EChandrasekar NHarrison JHarding TAbbott RRothman RLPagan IKorzekwinski KRobbs LIsmail STalati RWilliamson JRobinson MZamora YBugajski ARandle DMahadevan AGrindstaff JRoman ASheets MRobinson PMcKee ACrow MNguyen JPickell NSmith JPosey FAlmanzar MBrown LGraves JShenkman EBeauchaine MVermillion KShah BOlivo JCooper AKavtaradze DfalseHigher-Dose Fluvoxamine and Time to Sustained Recovery in Outpatients With COVID-19: The ACTIV-6 Randomized Clinical Trial.<h4>Importance</h4>The effect of higher-dose fluvoxamine in reducing symptom duration among outpatients with mild to moderate COVID-19 remains uncertain.<h4>Objective</h4>To assess the effectiveness of fluvoxamine, 100 mg twice daily, compared with placebo, for treating mild to moderate COVID-19.<h4>Design, setting, and participants</h4>The ACTIV-6 platform randomized clinical trial aims to evaluate repurposed medications for mild to moderate COVID-19. Between August 25, 2022, and January 20, 2023, a total of 1175 participants were enrolled at 103 US sites for evaluating fluvoxamine; participants were 30 years or older with confirmed SARS-CoV-2 infection and at least 2 acute COVID-19 symptoms for 7 days or less.<h4>Interventions</h4>Participants were randomized to receive fluvoxamine, 50 m2023-01-01T00:00:00Z2023 Dec2026-06-01T18:50:54.881Z2026-05-19T03:07:10.385ZS-EPMC106566703797607210.1001/jama.2023.23363