Effect of fluvoxamine on preventing neuropsychiatric symptoms of post COVID syndrome in mild to moderate patients, a randomized placebo-controlled double-blind clinical trial
Ramin Hamidi Farahani, Ali Ajam, Alireza Ranjbar Naeini
BMC Infectious Diseases, doi:10.1186/s12879-023-08172-5
Background Shortly after the Coronavirus disease 2019 (COVID-19) pandemic, a considerable number of recovered patients reported persisting symptoms, especially neuropsychological manifestations, which were later named post-COVID syndrome (PCS). Immune dysregulation was suggested as one of the main mechanisms for PCS. Fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) that is mostly used to treat depression, anxiety disorders, and obsessivecompulsive disorder, has been suggested as an anti-COVID drug due to its anti-inflammatory effects, mainly through the sigma-1 receptor. Therefore, we aimed to evaluate fluvoxamine's effect on PCS neuropsychiatric symptoms.
Method In this double-blind randomized clinical trial, we included confirmed mild to moderate COVID-19 outpatients using polymerase chain reaction (PCR) by an infectious disease specialist. The presence of severe COVID-19 symptoms was evaluated by the infectious disease specialist and included dyspnea, SpO2 < 94% on room air, PaO2/ FiO2 < 300 mm Hg, a respiratory rate > 30 breaths/min, and lung infiltrates > 50%. Then we performed permuted block randomization and assigned patients 1:1 into two groups to either receive fluvoxamine 100 mg tablet or a placebo daily for 10 days. Eligible patients were evaluated after 12 weeks for the presence of fatigue, as the primary, and other PCS symptoms as secondary outcomes.
Results We screened a total of 486 patients from March to June 2022. After 12 weeks, 42 patients receiving fluvoxamine and 43 patients receiving Placebo were evaluated for PCS. Patients had a mean age of 38.5 ± 14.1 and 48% of them were women. Fatigue was significantly lower in the fluvoxamine group (p-value 0.026). No significant differences were observed in other symptoms.
Conclusion We concluded that taking fluvoxamine during active COVID-19 can reduce the chance of fatigue but the advantage of fluvoxamine was not observed for other symptoms. Further studies are necessary to confirm these preliminary results.
Authors' contributions A. Ajam contributed to interpreting the data, draft writing, and final editing. A. Ranjbar Naeini contributed to research design and final editing. R. Hamidi Farahani contributed to the research design and revised it critically. The author(s) read and approved the final manuscript.
Funding All funding support was provided by the AJAUMS.
Declarations Ethics approval and consent to participate Informed consent was obtained from all study participants. The protocol of this study is by the 2013 Helsinki declaration and was approved by the Ethics Committee of AJA University of Medical Sciences (AJAUMS), Ethics ID: IR.AJAUMS.REC.1400.302. This RCT was registered in the Iranian registry of clinical trials (IRCT), a primary registry in the WHO registry network (registration number: IRCT20220526054990N1) on 01/06/2022.
Consent for publication Not applicable.
Competing interests The authors declare no competing interests.
Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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