A meta-analysis regarding fluvoxamine and hospitalization risk of COVID-19 patients: TOGETHER making a difference

Marčec, Robert; Dodig, Vinko Michael; Likić, Robert

doi:10.1016/j.jinf.2022.11.011

Cited by 6 publications

(7 citation statements)

References 4 publications

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“…The TOGETHER trial performed in an ambulatory setting reported a significantly lower risk of emergency department retention >6 h or hospital admission with fluvoxamine use compared with placebo [79 [11%] of 741 versus 119 [16%] of 756; relative risk [RR] 0.68; 95% Bayesian credible interval [95% BCI] = 0.52-0.88] [18,66]. Three recent systematic reviews and meta-analyses reported that fluvoxamine significantly and substantially reduced hospitalization risk among outpatients with COVID-19 [13][14][15][16]. Finally, a prospective cohort study of patients admitted to the ICU for COVID-19 reported a significant association between the 15-day use of fluvoxamine and reduced mortality [20].…”

Section: Discussionmentioning

confidence: 99%

Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study

et al. 2023

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Prior research suggests that fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) used for the treatment of obsessive-compulsive disorder and major depressive disorder, could be repurposed against COVID-19. We undertook a prospective interventional open-label cohort study to evaluate the efficacy and tolerability of fluvoxamine among inpatients with laboratory-confirmed COVID-19 in Uganda. The main outcome was all-cause mortality. Secondary outcomes were hospital discharge and complete symptom resolution. We included 316 patients, of whom 94 received fluvoxamine in addition to standard care [median age, 60 years (IQR = 37.0); women, 52.2%]. Fluvoxamine use was significantly associated with reduced mortality [AHR = 0.32; 95% CI = 0.19–0.53; p < 0.001, NNT = 4.46] and with increased complete symptom resolution [AOR = 2.56; 95% CI = 1.53–5.51; p < 0.001, NNT = 4.44]. Sensitivity analyses yielded similar results. These effects did not significantly differ by clinical characteristic, including vaccination status. Among the 161 survivors, fluvoxamine was not significantly associated with time to hospital discharge [AHR 0.81, 95% CI (0.54–1.23), p = 0.32]. There was a trend toward greater side effects with fluvoxamine (7.45% versus 3.15%; SMD = 0.21; χ2 = 3.46, p = 0.06), most of which were light or mild in severity and none of which were serious. One hundred mg of fluvoxamine prescribed twice daily for 10 days was well tolerated and significantly associated with reduced mortality and with increased complete symptom resolution, without a significant increase in time to hospital discharge, among inpatients with COVID-19. Large-scale randomized trials are urgently needed to confirm these findings, especially for low- and middle-income countries, where access to vaccines and approved treatments against COVID-19 is limited.

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Section: Discussionmentioning

confidence: 99%

Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study

et al. 2023

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“…This study has limitation. From the results of several meta-analyses, there is an ongoing debate over the beneficial effects of fluvoxamine for COVID-19 [96][97][98][99][100][101][102][103]. A recent meta-analysis using 6 randomized clinical trials and 5 observational studies demonstrated that the medium dose (100 mg twice daily) of fluvoxamine, but not low dose (50 mg twice daily), was associated with a 21% reduction in the risk of hospitalization, and a 28% reduction in the risk of mortality [104].…”

Section: Limitationmentioning

confidence: 99%

Overview of the potential use of fluvoxamine for COVID-19 and long COVID

Hashimoto

2023

Discov Ment Health

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Coronavirus disease 2019 (COVID-19) has presented a serious worldwide threat to public health since its emergence in late 2019. From a safety point of view, drug repurposing has received particular attention. Several clinical studies have demonstrated that the use of fluvoxamine, a selective serotonin reuptake inhibitor with potent sigma-1 receptor agonism, in the early-stage of infection might be associated with the prevention of clinical deterioration in individuals with SARS-CoV-2 infection, although several reports have shown that a low dose of fluvoxamine may be ineffective. There is increasing evidence that SARS-CoV-2 can cross the blood–brain barrier, resulting in a number of psychiatric and neurologic symptoms in COVID-19 survivors. Importantly, about half of COVID-19 survivors experience a variety of long-term sequelae, including psychiatric and neurologic symptoms, known as long COVID. In this priority review, the author presents an overview of the potential use of fluvoxamine in the treatment of COVID-19 and long COVID.

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“…Similar results were also obtained from the meta-analysis conducted by Cheema et al [ 18 ]. However, following the publication of the TOGETHER study results [ 10 ], Marcec et al reanalyzed the hospitalization outcome using the information provided by Cheema while also included hospitalization data from the TOGETHER trial [ 19 ]. They found that fluvoxamine does, in fact, statistically significantly lower the probability of hospitalization in COVID-19 outpatients, which was in line with our findings.…”

Section: Discussionmentioning

confidence: 99%

The efficacy and safety of fluvoxamine in patients with COVID-19: A systematic review and meta-analysis from randomized controlled trials

Zhou,

Zhao,

Pan

et al. 2024

PLoS ONE

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Background Recently, several randomized controlled trials (RCTs) of fluvoxamine have been successfully conducted for the treatment of patients with coronavirus disease 2019 (COVID-19). This systematic review and meta-analysis was to evaluate the efficacy and safety of fluvoxamine in patients with COVID-19. Methods MEDLINE, EMBASE, Cochrane Library and clinicaltrials.gov were searched for RCTs which were performed to evaluate fluvoxamine and placebo up to January 31, 2024. Review Manager 5.3 was used to perform meta-analysis. The risk ratio (RR) and mean difference (MD) was analyzed and calculated with a random effect model. Results We pooled 4,711 participants from six RCTs (2,382 in the fluvoxamine group and 2,329 in the placebo group). Compared to the placebo group, the fluvoxamine group had a significantly lower rate of clinical deterioration (RR, 0.73; P = 0.004; 95% CI, 0.59 to 0.90; I2 = 0%) and hospitalization (RR, 0.76; P = 0.04; 95% CI, 0.59 to 0.99; I2 = 0%). In the meantime, compared with the placebo group, fluvoxamine group did not show any higher risk of AEs (P = 0.13 and 0.91, respectively) in safety outcomes analysis. The subgroup analysis showed that fluvoxamine treatment performed more than 200 mg daily appears to be more effective than those performed less than 200 mg daily in reducing clinical deterioration and hospitalization risks, while not exhibiting higher AE and SAE risks than placebo group. Conclusion Fluvoxamine for patients with COVID-19, especially those who take 200 mg or more daily, is superior to the placebo group in reducing clinical deterioration and hospitalization, and did not show any higher risk of AEs and SAEs in safety concerns, which might be a promising intervention for COVID-19.

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A meta-analysis regarding fluvoxamine and hospitalization risk of COVID-19 patients: TOGETHER making a difference

Cited by 6 publications

References 4 publications

Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study

Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study

Overview of the potential use of fluvoxamine for COVID-19 and long COVID

The efficacy and safety of fluvoxamine in patients with COVID-19: A systematic review and meta-analysis from randomized controlled trials

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