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All Studies   Meta Analysis    Recent:   

The STOP COVID 2 study: Fluvoxamine vs placebo for outpatients with symptomatic COVID-19, a fully-remote randomized controlled trial

Reiersen et al., Open Forurm Infectious Diseases, doi:10.1093/ofid/ofad419 (results 8/20/2021), STOP COVID 2, NCT04668950
Aug 2021  
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0 0.5 1 1.5 2+ Oxygen therapy, NIV -201% Improvement Relative Risk Oxygen therapy 33% Oxygen therapy, PP 38% Hospitalization 9% Progression 12% primary Fluvoxamine  STOP COVID 2  EARLY TREATMENT  DB RCT Is early treatment with fluvoxamine beneficial for COVID-19? Double-blind RCT 547 patients in the USA (December 2020 - May 2021) Trial underpowered to detect differences c19early.org Reiersen et al., Open Forurm Infectiou.., Aug 2021 Favors fluvoxamine Favors control
26th treatment shown to reduce risk in November 2021
 
*, now known with p = 0.00014 from 21 studies, recognized in 3 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
Remote RCT 547 outpatients a median of 5 days from onset, showing no significant differences with fluvoxamine. The trial was stopped early and underpowered due to low event rates. The trial does not report outcomes that may not be underpowered like time to recovery. Authors note that treatment may have been too late.
risk of oxygen therapy, 201.1% higher, RR 3.01, p = 0.50, treatment 1 of 272 (0.4%), control 0 of 275 (0.0%), continuity correction due to zero event (with reciprocal of the contrasting arm), non-invasive ventilation.
risk of oxygen therapy, 32.6% lower, RR 0.67, p = 0.60, treatment 6 of 272 (2.2%), control 9 of 275 (3.3%), NNT 94.
risk of oxygen therapy, 37.5% lower, RR 0.62, p = 0.74, treatment 3 of 164 (1.8%), control 6 of 205 (2.9%), NNT 91, per-protocol.
risk of hospitalization, 9.0% lower, RR 0.91, p = 1.00, treatment 9 of 272 (3.3%), control 10 of 275 (3.6%), NNT 305.
risk of progression, 12.4% lower, RR 0.88, p = 0.85, treatment 13 of 272 (4.8%), control 15 of 275 (5.5%), NNT 148, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Reiersen et al., 20 Aug 2021, Double Blind Randomized Controlled Trial, USA, peer-reviewed, median age 47.0 (treatment) 48.0 (control), 24 authors, study period 22 December, 2020 - 21 May, 2021, average treatment delay 5.0 days, trial NCT04668950 (history) (STOP COVID 2).
This PaperFluvoxamineAll
The STOP COVID 2 study: Fluvoxamine vs placebo for outpatients with symptomatic COVID-19, a fully-remote randomized controlled trial
MD, MPE Angela M Reiersen, MD Caline Mattar, Rachel A Bender Ignacio, MD, MPH David R Boulware, MD, MPH Todd C Lee, MD Rachel Hess, Alexander J Lankowski, MDCM, MSc, FRCPC Emily G Mcdonald, J Philip Miller, MD William G Powderly, MD Matthew F Pullen, MD, MPH Jeffrey T Rado, MD Michael W Rich, MD, MSc Joshua T Schiffer, Julie Schweiger, MD Adam M Spivak, BS Angela Stevens, MD, MSc, FRCPC Simone N Vigod, MD Payal Agarwal, MPH, MSIS Lei Yang, MS Michael Yingling, PhD Torie R Gettinger, MD Charles F Zorumski, MD Eric J Lenze
Open Forum Infectious Diseases, doi:10.1093/ofid/ofad419
Background: Prior randomized clinical trials have reported benefit of fluvoxamine >200mg/day vs placebo for patients infected with severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Methods: This randomized, double-blind, placebo-controlled, fully-remote multi-site clinical trial evaluated whether fluvoxamine prevents clinical deterioration in higher-risk outpatients with acute COVID-19. Between December 2020 and May 2021, non-hospitalized US and Canadian participants with confirmed symptomatic infection received fluvoxamine (50mg on Day 1, 100mg twice daily thereafter) or placebo for 15 days. The primary modified intent -to-treat (mITT) population included participants who started the intervention within 7 days of symptom onset with a baseline oxygen saturation ≥ 92%. The primary outcome was clinical deterioration within 15 days of randomization defined as having both (1) shortness of breath (severity ≥ 4 on 0-10 scale or requiring hospitalization), and (2) oxygen saturation <92% on room air or need for supplemental oxygen. Results: A total of 547 participants were randomized and met mITT criteria (n=272 fluvoxamine, n=275 placebo). The Data Safety Monitoring Board recommended stopping early for futility related to lower than predicted event rate and declining accrual concurrent with vaccine availability in the U.S. and Canada. Clinical deterioration occurred in 13 (4.8%) participants in the fluvoxamine group and 15 (5.5%) participants in the placebo group (absolute difference at day 15, 0.68% [95% CI, -3.0 % to 4.4 %]; log rank P=0.91). Conclusions: This trial did not find fluvoxamine efficacious in preventing clinical deterioration in unvaccinated outpatients with symptomatic COVID-19. It was stopped early and underpowered due to low primary outcome rates.
References
Bramante, Huling, Tignanelli, Randomized Trial of Metformin, Ivermectin, and Fluvoxamine for Covid-19, N Engl J Med, doi:10.1056/NEJMoa2201662
Cummings, Clinical Trials Without Clinical Sites, JAMA Intern Med, doi:10.1001/jamainternmed.2020.9223
Gottlieb, Vaca, Paredes, Early Remdesivir to Prevent Progression to Severe Covid-19 in Outpatients, N Engl J Med, doi:10.1056/NEJMoa2116846
Ibrahim, Lowe, Bramante, Metformin and Covid-19: Focused Review of Mechanisms and Current Literature Suggesting Benefit, Front Endocrinol (Lausanne), doi:10.3389/fendo.2021.587801
Kornhuber, Hoertel, Gulbins, The acid sphingomyelinase/ceramide system in COVID -19. Mol Psychiatry, doi:10.1038/s41380-021-01309-5
Lee, Vigod, Bortolussi-Courval, Fluvoxamine for Outpatient Management of COVID-19 to Prevent Hospitalization: A Systematic Review and Meta-analysis, JAMA Network Open, doi:10.1001/jamanetworkopen.2022.6269
Lenze, Mattar, Zorumski, Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial, JAMA, doi:10.1001/jama.2020.22760
Mccarthy, Naggie, Boulware, Effect of Fluvoxamine vs Placebo on Time to Sustained Recovery in Outpatients With Mild to Moderate COVID-19: A Randomized Clinical Trial, JAMA, doi:10.1001/jama.2022.24100
Reis, Santos Moreira-Silva, Silva, 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, doi:10.1016/S2214-109X(21)00448-4
Reis, Santos, Silva, Silva, Oral Fluvoxamine With Inhaled Budesonide for Treatment of Early-Onset COVID-19 : A Randomized Platform Trial, Ann Intern Med, doi:10.7326/M22-3305
Rosen, Seki, Fernandez-Castaneda, Modulation of the sigma-1 receptor-IRE1 pathway is beneficial in preclinical models of inflammation and sepsis, Sci Transl Med. Feb, doi:10.1126/scitranslmed.aau5266
Sukhatme, Reiersen, Vayttaden, Sukhatme, Fluvoxamine: A Review of Its Mechanism of Action and Its Role in COVID-19. Perspective, Frontiers in Pharmacology, doi:10.3389/fphar.2021.652688
Wiersinga, Rhodes, Cheng, Peacock, Prescott, Pathophysiology, Transmission, Diagnosis, and Treatment of Coronavirus Disease 2019 (COVID-19): A Review, JAMA, doi:10.1001/jama.2020.12839
Zaid, Guessous, Puhm, Platelet reactivity to thrombin differs between patients with COVID-19 and those with ARDS unrelated to COVID-19, Blood Adv, doi:10.1182/bloodadvances.2020003513
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Between December 2020 ' 'and May 2021, nonhospitalized US and Canadian participants with confirmed symptomatic ' 'infection received fluvoxamine (50\u2005mg on day 1, 100\u2005mg twice daily thereafter) or ' 'placebo for 15 days. The primary modified intent-to-treat (mITT) population included ' 'participants who started the intervention within 7 days of symptom onset with a baseline ' 'oxygen saturation ≥92%. The primary outcome was clinical deterioration within 15 days of ' 'randomization, defined as having both (1) shortness of breath (severity ≥4 on a 0–10 scale or ' 'requiring hospitalization) and (2) oxygen saturation &amp;lt;92% on room air or need for ' 'supplemental oxygen.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A total of 547 participants were randomized and met mITT criteria ' '(n = 272 fluvoxamine, n = 275 placebo). The Data Safety Monitoring Board recommended stopping ' 'early for futility related to lower-than-predicted event rates and declining accrual ' 'concurrent with vaccine availability in the United States and Canada. Clinical deterioration ' 'occurred in 13 (4.8%) participants in the fluvoxamine group and 15 (5.5%) participants in the ' 'placebo group (absolute difference at day 15, 0.68%; 95% CI, −3.0% to 4.4%; log-rank P = ' '.91).</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>This trial did not find fluvoxamine efficacious in preventing ' 'clinical deterioration in unvaccinated outpatients with symptomatic COVID-19. 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