AbstractThere have been 774,075,242 cases of COVID-19 and 7,012,986 deaths worldwide as of January 2024. In the early stages of the pandemic, there was an urgent need to reduce the severity of the disease and prevent the need for hospitalization to avoid stress on healthcare systems worldwide. The repurposing of drugs to prevent clinical deterioration of COVID-19 patients was trialed in many studies using many different drugs.

摘要截至2024年1月，全世界共有774075242例新型冠状病毒肺炎病例和7012986例死亡病例。在大流行的早期阶段，迫切需要降低疾病的严重程度，并防止需要住院治疗，以避免对全球医疗系统造成压力。在许多使用许多不同药物的研究中，对药物的重新用途进行了试验，以防止新型冠状病毒肺炎患者的临床恶化。

Fluvoxamine (an SSRI and sigma-1 receptor agonist) was initially identified to potentially provide beneficial effects in COVID-19-infected patients, preventing clinical deterioration and the need for hospitalization. Fourteen clinical studies have been carried out to date, with seven of those being randomized placebo-controlled studies.

氟伏沙明（一种SSRI和sigma-1受体激动剂）最初被确定为可能对COVID-19感染患者提供有益作用，防止临床恶化和住院治疗的需要。迄今为止，已经进行了14项临床研究，其中7项是随机安慰剂对照研究。

This systematic review and meta-analysis covers the literature from the outbreak of SARS-CoV-2 in late 2019 until January 2024. Search terms related to fluvoxamine, such as its trade names and chemical names, along with words related to COVID-19, such as SARS-CoV-2 and coronavirus, were used in literature databases including PubMed, Google Scholar, Scopus, and the ClinicalTrials.gov database from NIH, to identify the trials used in the subsequent analysis.

本系统评价和荟萃分析涵盖了2019年末至2024年1月SARS-CoV-2爆发的文献。在PubMed，Google Scholar，Scopus和NIH的ClinicalTrials.gov数据库等文献数据库中使用了与氟伏沙明相关的搜索词，如其商品名和化学名称，以及与COVID-19相关的词，如SARS-CoV-2和冠状病毒，以确定后续分析中使用的试验。

Clinical deterioration and death data were extracted from these studies where available and used in the meta-analysis. A total of 7153 patients were studied across 14 studies (both open-label and double-blind placebo-controlled). 681 out of 3553 (19.17%) in the standard care group and 255 out of 3600 (7.08%) in the fluvoxamine-treated group experienced clinical deterioration.

临床恶化和死亡数据是从这些研究中提取的，并用于荟萃分析。在14项研究（开放标签和双盲安慰剂对照）中共研究了7153名患者。标准治疗组3553例中有681例（19.17%），氟伏沙明治疗组3600例中有255例（7.08%）出现临床恶化。

The estimated average log odds ratio was 1.087 (95% CI 0.200 to 1.973), which differed significantly from zero (z = 2.402, p = 0.016). The seven placebo-controlled studies resulted in a log .

估计的平均对数优势比为1.087（95%CI为0.200至1.973），与零有显着差异（z=2.402，p=0.016）。七项安慰剂对照研究产生了一个日志。

IntroductionThe outbreak of COVID-19 was caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)1. Since its outbreak in Wuhan, China, in December 2019, COVID-19 has rapidly spread worldwide, leading to one of the deadliest pandemics in modern history2,3. With over 774 million cases and 7 million deaths globally by January 2024, the virus has had a profound impact on public health4.

引言新型冠状病毒肺炎的爆发是由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）1引起的。自2019年12月在中国武汉爆发以来，新型冠状病毒（COVID-19）在世界范围内迅速传播，导致现代史上最致命的流行病之一2,3。到2024年1月，全球共有7.74亿例病例和700万人死亡，该病毒对公共卫生产生了深远影响4。

Various mutations, such as the delta, lambda, mu, and omicron variants, have continued to drive the death toll and have led to widespread lockdowns to control the spread of the virus5,6,7. However, the advent of vaccines has significantly reduced the disease's severity and mortality rate.COVID-19 is now considered in the differential diagnosis for several common neurological syndromes, including encephalopathy, encephalitis, stroke, and Guillain-Barré syndrome8.

各种突变，例如delta，lambda，mu和omicron变体，继续驱动死亡人数，并导致广泛的锁定以控制病毒的传播5,6,7。然而，疫苗的出现大大降低了疾病的严重程度和死亡率。COVID-19现在被认为是几种常见神经系统综合征的鉴别诊断，包括脑病，脑炎，中风和格林-巴利综合征8。

Approximately half of COVID-19 survivors experience long-term effects, known as post-acute sequelae of COVID-19 (PASC) or Long-covid9. Symptoms of Long-covid encompass a wide range of issues, including sleep disturbances, anxiety, depression, brain fog, and fatigue. These persistent symptoms are linked to several mechanisms, such as neuroinflammation, blood–brain barrier breakdown, and neurodegeneration10.One drug that could be used for treatment that emerged early in the pandemic is fluvoxamine, which was initially used for obsessive–compulsive disorder and major depression11.

大约一半的COVID-19幸存者经历了长期影响，称为COVID-19（PASC）或长期covid9的急性后遗症。长期新型冠状病毒的症状包括广泛的问题，包括睡眠障碍，焦虑，抑郁，脑雾和疲劳。这些持续的症状与多种机制有关，例如神经炎症，血脑屏障破坏和神经退行性疾病10。在大流行早期出现的一种可用于治疗的药物是氟伏沙明，最初用于强迫症和严重抑郁症11。

Fluvoxamine was tested for the treatment of COVID-19 due to its sigma-1 receptor (σ1R) agonist action, which has anti-inflammatory effects12. This action helps prevent excessive cytokine production, potentially reducing clinical deterioration in COVID-19 patients. Additional hypothesized mechanisms include inhibition of acid sphingomyelinase.

氟伏沙明由于其σ-1受体（σ1R）激动剂作用而被测试用于治疗COVID-19，其具有抗炎作用12。这一行动有助于防止过度的细胞因子产生，有可能减少COVID-19患者的临床恶化。其他假设的机制包括抑制酸性鞘磷脂酶。

Table 1 Summary of Clinical Studies on Fluvoxamine Included in the Systematic Review and Meta-Analysis. This table provides detailed information on all the clinical studies using fluvoxamine that were included in the systematic review and meta-analysis.Full size tableLiterature quality scoringThe clinical studies identified by this manuscript were scored based on a set of questions previously devised for the literature quality scoring36, expanded from the JADAD scoring system for clinical trials37.

表1系统评价和荟萃分析中氟伏沙明的临床研究总结。该表提供了系统评价和荟萃分析中包括的所有使用氟伏沙明的临床研究的详细信息。全尺寸表格文献质量评分本手稿确定的临床研究是根据先前为文献质量评分36设计的一组问题进行评分的，这些问题是从JADAD临床试验评分系统37扩展而来的。

Each question carried 1 point for a positive answer, and 1 point was subtracted for a negative answer. The maximum score was 12, and the minimum was -11 (question 2 depended on a positive answer to question 1). The quality scoring questions were as follows:.

每个问题的肯定答案加1分，否定答案减1分。最高分为12分，最低分为-11分（问题2取决于对问题1的肯定回答）。质量评分问题如下：。

1.

1.

Was the study randomized?

这项研究是随机的吗？

2.

2.

If yes to question 1, was the randomization appropriate?

如果问题1是，随机化是否合适？

3.

3.

Was the study double-blinded?

这项研究是双盲的吗？

4.

4.

Was there a description of any withdrawals from the study?

是否有任何退出研究的描述？

5.

5.

Was there a clear description of the inclusion/exclusion criteria for the study?

是否明确描述了该研究的纳入/排除标准？

6.

6.

Was there an appropriate control group?

是否有适当的对照组？

7.

7.

Was the dose appropriate?

剂量合适吗？

8.

8.

Were the adverse effects monitored and described?

是否对不良反应进行了监测和描述？

9.

9.

Was the method of statistical analysis described?

是否描述了统计分析方法？

10.

10.

Was there an appropriate follow-up of patients?

是否对患者进行了适当的随访？

11.

11.

Are the primary and secondary outcomes clearly defined?

主要和次要结果是否明确定义？

12.

12.

Have the results of the study been published?

研究结果发表了吗？

A positive outcome in the scoring was considered appropriate for entering data into the meta-analysis. For the quality scoring, the Active-6 studies were assessed as one study.Data collection and statistical analysisAll eligible manuscripts and data sets available before the end of January 2024 were selected and included in the study.Data were extracted from the eligible publications or data sets, and the meta-analysis was carried out using Jamovi computer software (Version 2.4.8.0 for Mac) (https://www.jamovi.org)38, and IBM SPSS Statistics (Version 29.0.1.0 (171) for Mac) (https://www.ibm.com/products/spss-statistics).

评分的积极结果被认为适合将数据输入荟萃分析。对于质量评分，Active-6研究被评估为一项研究。数据收集和统计分析选择了2024年1月底之前可用的所有符合条件的手稿和数据集，并将其纳入研究。数据是从符合条件的出版物或数据集中提取的，荟萃分析是使用Jamovi计算机软件（Mac版本2.4.8.0）进行的(https://www.jamovi.org)38和IBM SPSS Statistics（Mac版本29.0.1.0（171））(https://www.ibm.com/products/spss-statistics)。

In the analysis of mortality, we only included studies that had a death in at least one of the groups (fluvoxamine or standard care/placebo) to avoid bias caused by the different group sizes. The estimated mean difference, 95% CI, and p value were presented. Heterogeneity statistics were presented with the I2 value and its corresponding p value.

在死亡率分析中，我们只包括至少一组（氟伏沙明或标准护理/安慰剂）死亡的研究，以避免由不同群体规模引起的偏倚。给出了估计的平均差异，95%CI和p值。异质性统计数据以I2值及其相应的p值表示。

Data was presented as a Forrest plot showing each study's weighted log odds ratio and the estimated mean difference for the combined studies. Publication bias was assessed using the Rosenthal approach to the Fail-safe N (file draw analysis) and presented with a funnel plot. The analysis used the log odds ratio as the outcome measure, and a random-effects model was fitted to the data.

数据显示为Forrest图，显示每项研究的加权对数优势比和组合研究的估计平均差异。使用Rosenthal方法对故障安全N（文件绘制分析）评估了发表偏倚，并给出了漏斗图。该分析使用对数优势比作为结果指标，并对数据拟合了随机效应模型。

The amount of heterogeneity (i.e., tau2) was estimated using the restricted maximum-likelihood estimator39. In addition to the estimate of tau2, the Q-test for heterogeneity and the I2 statistics were calculated. If any amount of heterogeneity was detected (i.e., tau2 > 0, regardless of the results of the Q-test), a prediction interval for the true outcomes was also provided.

使用受限最大似然估计量39估计异质性的量（即tau2）。除了tau2的估计之外，还计算了异质性的Q检验和I2统计量。如果检测到任何数量的异质性（即tau2>，无论Q检验的结果如何），也提供了真实结果的预测区间。

Studentized residuals and Cook's distances were used to e.

学生化残差和库克距离用于e。

Meta-analysis-subgrouping analysisAt the start of this study, we set out to discover if certain aspects of fluvoxamine treatment for COVID-19, such as dose or time to intervention, affected the study's outcome. Furthermore, there were some indications of heterogeneity in the above meta-analysis. Therefore, we have carried out subgrouping analysis, splitting the data into groupings as follows: High (200 mg or more/day) and low dose (less than 200 mg) (we also further divided the doses into up to 300 mg/ day, up to 200 mg/day and up to 100 mg/day) and time to intervention, early (within three days) and medium (within four to seven days) and late (within eight to ten days).

荟萃分析亚组分析在本研究开始时，我们着手发现氟伏沙明治疗COVID-19的某些方面（如干预剂量或时间）是否影响研究结果。此外，在上述荟萃分析中有一些异质性的迹象。因此，我们进行了亚组分析，将数据分为以下几组：高剂量（200毫克或更多/天）和低剂量（少于200毫克）（我们还将剂量进一步分为高达300毫克/天，高达200毫克/天，高达100毫克/天）和干预时间，早期（三天内）和中期（四到七天内）和晚期（八到十天内）。

We chose the grouping based on the observation that the low-dose studies tended to be the ones that were less likely to result in a positive outcome for fluvoxamine. We chose time for treatment as, early in the pandemic, it became clear that the second week of infection was where clinical deterioration became apparent, and at that point, starting drug treatment became less effective.Fluvoxamine high/low dose subgroup analysis in clinical deteriorationNine studies employed a high dose (≥ 200 mg/day), and five used a low dose (< 200 mg/day).

我们选择分组是基于以下观察结果：低剂量研究往往不太可能导致氟伏沙明的阳性结果。我们选择了治疗时间，因为在大流行早期，很明显感染的第二周是临床恶化变得明显的地方，到那时，开始药物治疗变得不那么有效。临床恶化中的氟伏沙明高/低剂量亚组分析9项研究采用高剂量（≥200 mg/天），5项使用低剂量（<200 mg/天）。

These were grouped and analyzed (Figs. 5 and 6), covering 4655 patients. 373 from 2158 (17.2%) in the standard care group and 213 from 2497 (8.5%) in the fluvoxamine group succumbed to clinical deterioration.Figure 5Meta-analysis for all the studies on fluvoxamine treatment of COVID-19 and clinical deterioration sub-grouped by dose.

对这些患者进行分组和分析（图5和6），涵盖4655名患者。标准治疗组2158例（17.2%）中有373例，氟伏沙明组2497例（8.5%）中有213例死于临床恶化。图5氟伏沙明治疗COVID-19和按剂量分组的临床恶化的所有研究的ETA分析。

(A) Forrest plot. High dose LogOR 0.6957 (95% CI 0.3777 to 1.0137) z = 4.2882, p < 0.0001. Low dose LogOR 1.198 (95% CI -0.930 to 3.325) z = 1.082, p = 0.279. (B) Funnel Plot. No Asymmetry was observed at either high or low dose grouping.F.

（A） Forrest图。高剂量LogOR 0.6957（95%CI 0.3777至1.0137）z=4.2882，p<0.0001。低剂量LogOR 1.198（95%CI-0.930至3.325）z=1.082，p=0.279。（B） 漏斗图。在高剂量或低剂量组中均未观察到不对称性。F。

Data availability

数据可用性

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

在当前研究期间生成和/或分析的数据集可根据合理要求从通讯作者处获得。

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Download referencesAcknowledgementsMIP is supported by the Ratchadapisek Sompote Fund for the Postdoctoral Fellowship, Chulalongkorn University. This research was supported by the Ratchadaprisk Sompoch Endowment Fund (2023), Chulalongkorn University (Sys_66_007_3700_001).Author informationAuthors and AffiliationsNatural Products for Neuroprotection and Anti-Ageing (Neur-Age Natura) Research Unit, Chulalongkorn University, Bangkok, 10330, ThailandMani Iyer Prasanth, Anchalee Prasansuklab, Tewin Tencomnao & James Michael BrimsonDepartment of Clinical Chemistry, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok, ThailandMani Iyer Prasanth & Tewin TencomnaoDepartment of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, JapanDhammika Leshan WannigamaDepartment of Microbiology, Faculty of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Thai Red Cross Society, Bangkok, ThailandDhammika Leshan WannigamaYamagata Prefectural University of Health Sciences, Kamiyanagi, Yamagata, 990-2212, JapanDhammika Leshan WannigamaPathogen Hunter’s Research Collaborative Team, Department of Infectious Diseases and Infection Control, Yamagata Prefectural Central Hospital, Yamagata, JapanDhammika Leshan WannigamaDepartment of Psychiatry, School of Medicine, Washington University in St.

下载参考文献致谢SMIP由朱拉隆功大学Ratchadapisek Sompote博士后奖学金基金支持。这项研究得到了朱拉隆功大学Ratchadaprisk Sompoch捐赠基金（2023）的支持（Sys\U 66\U 007\U 3700\U 001）。作者信息作者和附属机构朱拉隆功大学神经保护和抗衰老天然产物研究室，曼谷，10330，ThailandMani Iyer Prasanth，Anchalee Prasansuklab，Tewin Tencomnao＆James Michael Brimson朱拉隆功大学联合健康科学学院临床化学系，曼谷，ThailandMani Iyer Prasanth＆Tewin Tencomnao日本山形山形山形县中央医院传染病和感染控制系Hammika Leshan Wannigama朱拉隆功国王纪念医学院微生物学系泰国红十字会朱拉隆功大学医院，泰国曼谷，泰国达米卡，乐山万尼加山形县卫生科学大学，山形县神谷，990-2212，日本，哈米卡，乐山万尼加山形县中央医院传染病和感染控制系，病原体猎人研究合作团队，JapanDhammika Leshan Wannigama华盛顿大学医学院精神病学系。

Louis, St. Louis, MO, USAAngela Michelle ReiersenSiriraj Research Group in Immunobiology and Therapeutic Sciences, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandPremrutai ThitilertdechaCollege of Public Health Sciences, Chulalongkorn University, Bangkok, ThailandAnchalee PrasansuklabDepartment of Clinical Microscopy, Faculty of Allied Health Sciences, Chulalongkorn University, Bangkok,.

路易斯，圣路易斯，密苏里州，USANGELA MICHELLER ReiersenSiriraj免疫生物学和治疗科学研究小组，曼谷马希隆大学医学院Siriraj医院，泰国朱拉隆功大学公共卫生科学学院，曼谷，泰国朱拉隆功大学联合健康科学学院临床显微镜系，曼谷，。

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PubMed Google ScholarContributionsM.I.P.- Manuscript drafting—first draft & revisions, data collection, and contributed to analysis. D.L.W.—Manuscript drafting, editing and contributed to the analysis. A.M.R.- Manuscript drafting—first draft & revisions, editing, and contributed to analysis.

PubMed谷歌学术贡献。一、 手稿起草初稿和修订，数据收集，并为分析做出贡献。D、 L.W.-手稿起草，编辑并为分析做出了贡献。A、 M.R.-手稿起草初稿和修订，编辑并为分析做出贡献。

P.T.- Manuscript drafting and data collection. A.P- Funding acquisition, data collection, manuscript editing. T.T.- Funding acquisition, manuscript editing. S.B.- Funding acquisition and administration, data collection. J.M.B.- Conceived & designed the analysis, funding acquisition, data collection, and data analysis, Manuscript drafting first draft & revisions.Corresponding authorCorrespondence to.

P、 手稿起草和数据收集。A、 P-资金获取，数据收集，稿件编辑。T、 资金获取，稿件编辑。S、 B.资金获取和管理，数据收集。J、 M.B.构思并设计了分析，资金获取，数据收集和数据分析，手稿起草初稿和修订。对应作者对应。

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Competing interests

相互竞争的利益

AMR is listed as an inventor on a patent application related to methods of treating COVID-19 (including Sigma1 agonists and specifically fluvoxamine), which was filed by Washington University in St. Louis. No other author declares any potential conflict of interest or competing financial or non-financial interest in relation to the manuscript.

AMR被列为一项专利申请的发明人，该专利申请涉及治疗COVID-19的方法（包括Sigma1激动剂，特别是氟伏沙明），该专利申请由圣路易斯华盛顿大学提交。没有其他作者声明与稿件有关的任何潜在利益冲突或竞争性财务或非财务利益。

AMR is listed on a patent application that includes the use of σ1R agonists for the treatment of COVID-19. No other authors have any conflicts to declare..

AMR被列入专利申请，其中包括使用σ1R激动剂治疗COVID-19。没有其他作者需要声明任何冲突。。

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Reprints and permissionsAbout this articleCite this articlePrasanth, M.I., Wannigama, D.L., Reiersen, A.M. et al. A systematic review and meta-analysis, investigating dose and time of fluvoxamine treatment efficacy for COVID-19 clinical deterioration, death, and Long-COVID complications.

转载和许可本文引用本文Prasanth，M.I.，Wannigama，D.L.，Reiersen，A.M.等人的系统评价和荟萃分析，研究氟伏沙明治疗COVID-19临床恶化，死亡和长期COVID并发症的剂量和时间。

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Keywords(E)‐5‐methoxy‐1‐[4‐(trifluoromethyl)phenyl]pentan‐1‐one O‐2‐aminoethyl oxime)SARS-CoV-2PandemicSigma-1 receptor (σ1R)Drug repurposingPandemicCoronavirusAntidepressant

关键词（E）-5-甲氧基-1-[4-（三氟甲基）苯基]戊烷-1-酮O-2-氨基乙基肟）SARS-CoV-2PandemicSigma-1受体（σ1R）药物再利用泛冠病毒抗抑制剂

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