Fluvoxamine for COVID-19: real-time analysis of all 5 studies

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Database of all fluvoxamine COVID-19 studies. Submit updates/corrections.


Aug 23	Late	Reis et al., Preprint (Preprint)	death, ↓29.3%, p=0.26	Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: The Together randomized platform clinical trial
	Details Together Trial preprint showing significantly lower hospitalization/extended ER visits with treatment, per-protocol analysis RR 0.34 [0.20-0.54]; ITT analysis RR 0.71 [0.54-0.93]. Adherence was only 73.2%. Symptom onset was unspecified or..
Aug 23	Details Source PDF Late treatment study Late treatment study
	Reis et al., Preprint (Preprint)
	Effect of early treatment with fluvoxamine on risk of emergency care and hospitalization among patients with COVID-19: The Together randomized platform clinical trial
	Together Trial preprint showing significantly lower hospitalization/extended ER visits with treatment, per-protocol analysis RR 0.34 [0.20-0.54]; ITT analysis RR 0.71 [0.54-0.93]. Adherence was only 73.2%. Symptom onset was unspecified or >= 4 days for 57% of patients. The schedule of study activities specifies treatment administration only one day after randomization, adding an additional day delay. Overall mortality is high for the patient population. Results may be impacted by late treatment, poor SOC, and may be specific to local variants [1, 2]. The total dose used is less than half of that in Lenze et al. Per protocol analysis is not provided for mortality. There is an unusual amount of missing data raising questions about the reliability of data overall - age is unknown for 6.5% of patients according to the sub-group analysis. Both age <=50 and >50 show better results on the primary outcome than the overall result, indicating that the relatively low treatment effect seen in this study is driven more by patients with unknown age. NCT04727424. Also see [3]. [1] science.sciencemag.org/content/372/6544/815 [2] thelancet.com/article/S0140-6736(21)00183-5/fulltext [3] twitter.com/Covid19Crusher/status/1430170252575395843 risk of death, 29.3% lower, RR 0.71, p = 0.26, treatment 17 of 739 (2.3%), control 24 of 733 (3.3%), OR converted to RR. risk of hospitalization, 20.7% lower, RR 0.79, p = 0.17, treatment 74 of 739 (10.0%), control 92 of 733 (12.6%), OR converted to RR. extended ER observation or hospitalization, 66.0% lower, RR 0.34, p < 0.001, treatment 541, control 609, per protocol. extended ER observation or hospitalization, 29.0% lower, RR 0.71, p = 0.01, treatment 77 of 739 (10.4%), control 108 of 733 (14.7%), ITT. extended ER observation or hospitalization, 32.0% lower, RR 0.68, p = 0.01, treatment 77 of 728 (10.6%), control 108 of 722 (15.0%), mITT. risk of no virological cure, 37.0% higher, RR 1.37, p = 0.17, treatment 173 of 218 (79.4%), control 160 of 217 (73.7%), adjusted. Reis et al., 8/23/2021, Double Blind Randomized Controlled Trial, Brazil, South America, preprint, 25 authors.
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Aug 12	Review	Hoertel et al., Molecular Psychiatry, doi:10.1038/s41380-021-01254-3 (Review) (Peer Reviewed)	review	Repurposing antidepressants inhibiting the sphingomyelinase acid/ceramide system against COVID-19: current evidence and potential mechanisms
	Details Review of the mechanisms of action and clinical studies for the treatment of COVID-19 with FIASMA antidepressants such as fluoxetine, fluvoxamine, paroxetine, escitalopram, or amitriptyline.
Aug 12	Details Source PDF Review Review
	Hoertel et al., Molecular Psychiatry, doi:10.1038/s41380-021-01254-3 (Review) (Peer Reviewed)
	Repurposing antidepressants inhibiting the sphingomyelinase acid/ceramide system against COVID-19: current evidence and potential mechanisms
	Review of the mechanisms of action and clinical studies for the treatment of COVID-19 with FIASMA antidepressants such as fluoxetine, fluvoxamine, paroxetine, escitalopram, or amitriptyline. Hoertel et al., 8/12/2021, peer-reviewed, 12 authors.
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Jun 29	PrEP	Assanovich et al., Psychiatry, Psychotherapy and Clinical Psychology, doi:10.34883/PI.2021.12.2.007 (Peer Reviewed)		Fluvoxamine in the Treatment of Patients with COVID-19
	Details Report on the use of fluvoxamine for COVID-19 noting that "patients with COVID-19 taking fluvoxamine did not report clinical complications of coronavirus infection". Only the abstract is currently available.
Jun 29	Details Source PDF Pre-Exposure Prophylaxis study Pre-Exposure Prophylaxis study
	Assanovich et al., Psychiatry, Psychotherapy and Clinical Psychology, doi:10.34883/PI.2021.12.2.007 (Peer Reviewed)
	Fluvoxamine in the Treatment of Patients with COVID-19
	Report on the use of fluvoxamine for COVID-19 noting that "patients with COVID-19 taking fluvoxamine did not report clinical complications of coronavirus infection". Only the abstract is currently available. Assanovich et al., 6/29/2021, peer-reviewed, 1 author.
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Apr 20	Review	Sukhatme et al., Front. Pharmacol., doi:10.3389/fphar.2021.652688 (Review) (Peer Reviewed)	review	Fluvoxamine: A Review of Its Mechanism of Action and Its Role in COVID-19
	Details Review of mechanisms of action of fluvoxamine and other SSRIs that could be beneficial for COVID-19 treatment, including lower platelet aggregation, decreased mast cell degranulation, interference with endolysosomal viral trafficking, reg..
Apr 20	Details Source PDF Review Review
	Sukhatme et al., Front. Pharmacol., doi:10.3389/fphar.2021.652688 (Review) (Peer Reviewed)
	Fluvoxamine: A Review of Its Mechanism of Action and Its Role in COVID-19
	Review of mechanisms of action of fluvoxamine and other SSRIs that could be beneficial for COVID-19 treatment, including lower platelet aggregation, decreased mast cell degranulation, interference with endolysosomal viral trafficking, regulation of inositol-requiring enzyme 1α-driven inflammation, and increased melatonin levels. Sukhatme et al., 4/20/2021, peer-reviewed, 4 authors.
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Mar 6	Review	Kirsch, S. (Review) (Preprint)	review	COVID FAQ
	Details COVID FAQ from the founder of the COVID-19 Early Treatment Fund [1], including an extensive analysis of the fluvoxamine trials and other supporting evidence.
Mar 6	Details Source PDF Review Review
	Kirsch, S. (Review) (Preprint)
	COVID FAQ
	COVID FAQ from the founder of the COVID-19 Early Treatment Fund [1], including an extensive analysis of the fluvoxamine trials and other supporting evidence. [1] treatearly.org/ Kirsch et al., 3/6/2021, preprint, 1 author.
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Feb 1	Early	Seftel et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab050 (Peer Reviewed)	death/ICU, ↓83.9%, p=0.15	Prospective cohort of fluvoxamine for early treatment of COVID-19
	Details Prospective quasi-randomized (patient choice) study with 125 outpatients, 77 treated with fluvoxamine, showing lower death/ICU admission (0 of 77 vs. 2 of 48), lower hospitalization (0 of 77 vs. 6 of 48), and faster recovery with treatmen..
Feb 1	Details Source PDF Early treatment study Early treatment study
	Seftel et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab050 (Peer Reviewed)
	Prospective cohort of fluvoxamine for early treatment of COVID-19
	Prospective quasi-randomized (patient choice) study with 125 outpatients, 77 treated with fluvoxamine, showing lower death/ICU admission (0 of 77 vs. 2 of 48), lower hospitalization (0 of 77 vs. 6 of 48), and faster recovery with treatment. Note that 12 treatment patients were added but are not reflected in the table in the paper (because the numbers had been previously published and the IRB did not allow updating the table). risk of combined death/ICU, 83.9% lower, RR 0.16, p = 0.15, treatment 0 of 77 (0.0%), control 2 of 48 (4.2%), continuity correction due to zero event. risk of hospitalization, 94.0% lower, RR 0.06, p = 0.003, treatment 0 of 77 (0.0%), control 6 of 48 (12.5%), continuity correction due to zero event. risk of no recovery, 98.7% lower, RR 0.01, p < 0.001, treatment 0 of 77 (0.0%), control 29 of 48 (60.4%), continuity correction due to zero event. Seftel et al., 2/1/2021, prospective quasi-randomized (patient choice), USA, North America, peer-reviewed, 2 authors.
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Nov 12 2020	Early	Lenze et al., JAMA, doi:10.1001/jama.2020.22760 (Peer Reviewed)	progression, ↓92.7%, p=0.009	Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial
	Details RCT 152 outpatients, 80 treated with fluvoxamine showing lower progression with treatment (0 of 80 versus 6 of 72 control).
Nov 12 2020	Details Source PDF Early treatment study Early treatment study
	Lenze et al., JAMA, doi:10.1001/jama.2020.22760 (Peer Reviewed)
	Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19: A Randomized Clinical Trial
	RCT 152 outpatients, 80 treated with fluvoxamine showing lower progression with treatment (0 of 80 versus 6 of 72 control). risk of disease progression, 92.7% lower, RR 0.07, p = 0.009, treatment 0 of 80 (0.0%), control 6 of 72 (8.3%), continuity correction due to zero event, clinical deterioration over 15 days. risk of hospitalization, 82.0% lower, RR 0.18, p = 0.009, treatment 1 of 80 (1.2%), control 5 of 72 (6.9%), COVID-19 hospitalization within 15 days, see supplemental appendix for details. Lenze et al., 11/12/2020, Double Blind Randomized Controlled Trial, USA, North America, peer-reviewed, 11 authors.
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Aug 17 2020	Late	Hoertel et al., Molecular Psychiatry, doi:10.1038/s41380-021-01021-4 (Peer Reviewed)		Association between antidepressant use and reduced risk of intubation or death in hospitalized patients with COVID-19: results from an observational study
	Details Retrospective 7,230 hospitalized COVID-19 patients in France, 345 receiving an antidepressant medication within 48 hours of admission. There was a significant association between antidepressant use and reduced risk of intubation or death ..
Aug 17 2020	Details Source PDF Late treatment study Late treatment study
	Hoertel et al., Molecular Psychiatry, doi:10.1038/s41380-021-01021-4 (Peer Reviewed)
	Association between antidepressant use and reduced risk of intubation or death in hospitalized patients with COVID-19: results from an observational study
	Retrospective 7,230 hospitalized COVID-19 patients in France, 345 receiving an antidepressant medication within 48 hours of admission. There was a significant association between antidepressant use and reduced risk of intubation or death (HR 0.56, p < 0.001). Fluvoxamine is not included because there was only one person taking it in this study. Hoertel et al., 8/17/2020, peer-reviewed, 17 authors.
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Please send us corrections, updates, or comments. Vaccines and treatments are both extremely valuable and complementary. All practical, effective, and safe means should be used. Elimination of COVID-19 is a race against viral evolution. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases the risk of COVID-19 becoming endemic; and increases mortality, morbidity, and collateral damage. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. Treatment protocols for physicians are available from the FLCCC.

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