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The Real-World Effectiveness of Fluvoxamine Therapy in Mild to Moderate COVID-19 Patients; a Historical Cohort Study (Fluvoxa Trial)

Siripongboonsitti et al., Journal of Infection and Public Health, doi:10.1016/j.jiph.2023.10.010, Fluvoxa, TCTR20230401001
Oct 2023  
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Mortality 59% Improvement Relative Risk Ventilation -48% ICU admission 26% Oxygen therapy -67% Deterioration, day 14 42% Deterioration, day 5 35% Deterioration, day 2 33% Progression, ARDS -48% WHO-CPS, day 14 34% WHO-CPS, day 5 -8% WHO-CPS, day 2 -3% Viral clearance -4% Fluvoxamine for COVID-19  Fluvoxa  EARLY TREATMENT Is early treatment with fluvoxamine beneficial for COVID-19? Retrospective 752 patients in Thailand (April - July 2021) Higher need for oxygen therapy (p=0.02) and improved recovery (p<0.0001) c19early.org Siripongboonsitti et al., J. Infection.., Oct 2023 Favorsfluvoxamine Favorscontrol 0 0.5 1 1.5 2+
27th treatment shown to reduce risk in November 2021
 
*, now with p = 0.00014 from 21 studies, recognized in 3 countries.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 79 treatments. c19early.org
Retrospective 752 patients in Thailand showing mixed results with 50mg fluvoxamine bid. Authors note that trials showing benefit mostly used 100mg bid.
risk of death, 59.2% lower, RR 0.41, p = 1.00, treatment 0 of 234 (0.0%), control 1 of 518 (0.2%), NNT 518, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 28.
risk of mechanical ventilation, 47.6% higher, RR 1.48, p = 0.65, treatment 2 of 234 (0.9%), control 3 of 518 (0.6%).
risk of ICU admission, 26.2% lower, RR 0.74, p = 1.00, treatment 2 of 234 (0.9%), control 6 of 518 (1.2%), NNT 329.
risk of oxygen therapy, 67.3% higher, RR 1.67, p = 0.02, treatment 34 of 234 (14.5%), control 45 of 518 (8.7%).
risk of deterioration, 41.9% lower, RR 0.58, p = 0.08, treatment 13 of 217 (6.0%), control 49 of 475 (10.3%), NNT 23, day 14.
risk of deterioration, 35.0% lower, RR 0.65, p = 0.047, treatment 23 of 166 (13.9%), control 88 of 413 (21.3%), NNT 13, day 5.
risk of deterioration, 32.9% lower, RR 0.67, p = 0.004, treatment 51 of 217 (23.5%), control 132 of 377 (35.0%), NNT 8.7, day 2.
risk of progression, 47.6% higher, RR 1.48, p = 0.65, treatment 2 of 234 (0.9%), control 3 of 518 (0.6%), ARDS.
WHO-CPS, 33.6% lower, RR 0.66, p < 0.001, treatment mean 0.73 (±0.67) n=234, control mean 1.1 (±0.75) n=518, WHO-CPS score, day 14.
WHO-CPS, 7.9% higher, RR 1.08, p = 0.06, treatment mean 2.06 (±1.07) n=234, control mean 1.91 (±0.98) n=518, WHO-CPS score, day 5.
WHO-CPS, 3.3% higher, RR 1.03, p = 0.43, treatment mean 2.21 (±1.25) n=234, control mean 2.14 (±1.06) n=518, WHO-CPS score, day 2.
risk of no viral clearance, 3.6% higher, RR 1.04, p = 0.66, treatment 130 of 210 (61.9%), control 218 of 365 (59.7%), day 14.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Siripongboonsitti et al., 6 Oct 2023, retrospective, Thailand, peer-reviewed, 4 authors, study period 16 April, 2021 - 24 July, 2021, trial TCTR20230401001 (Fluvoxa). Contact: taweegrit.sir@cra.ac.th.
This PaperFluvoxamineAll
The Real-World Effectiveness of Fluvoxamine Therapy in Mild to Moderate COVID-19 Patients; a Historical Cohort Study (Fluvoxa Trial)
M.D. M.Sc Taweegrit Siripongboonsitti, Kriangkrai Tawinprai, M.D.M.Sc Paruspak Payoong, Nithi Mahanonda
Journal of Infection and Public Health, doi:10.1016/j.jiph.2023.10.010
Background: Fluvoxamine (FVX) has been proposed as a potential treatment for severe COVID-19 by the σ-1 receptor agonist, which can reduce cytokine production. However, the efficacy of FVX remains controversial. Methods: A historical retrospective cohort study was conducted in mild to moderate COVID-19 patients, 2:1 ratio of standard of care (SOC) and FVX treatments to assess the effectiveness of FVX in preventing deterioration by the fifth day of treatment. Results: Of 752 eligible patients, 234 received FVX while 518 received SOC, and there was no significant difference in the effectiveness of FVX and SOC in preventing clinical deterioration. On the fifth day after treatment, 86.1% of patients in the FVX-treated group did not experience clinical deterioration compared to 78.7% in the SOC group. Notably, the FVX group had higher rates of pneumonia development and hospitalization, requiring more oxygen supplementation while showing less reduction in viral shedding than the SOC group. However, no difference in mechanical ventilation use, ICU admission, and survival was observed. Conclusion: Fluvoxamine treatment is failed to demonstrate effectiveness in preventing deterioration in mild to moderate COVID-19 and may lead to a higher incidence of pneumonia, hospitalization, and oxygen supplementation, necessitating careful consideration before prescribing the drug for COVID-19. Trial registration: Thai clinical trials registry (TCTR) no.
Consent for publication Not applicable Competing interests The authors declare that they have no competing interests. Authors' Contributions T.S. had full access to all of the data in this study and took responsibility for the data's integrity and accuracy. T.S.-first authors. T.S.-Corresponding author, T.S., K.T., P.P., N.M. contributed equally to the study. Concept and design-T.S., N.M. Investigation-T.S., K.T., P.P., N.M., Acquisition, analysis, or interpretation of data: T.S.; Critical revision of the manuscript for important intellectual content: T.S.; Statistical analysis: A.K.; Obtained funding. N.M., T.S.; Administrative, technical, or material support: T.S.; Supervision: T.S., N.M. Conflict of interest statement The authors have no interest to declare J o u r n a l P r e -p r o o f
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. 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. FLCCC and WCH provide treatment protocols.
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