Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study.
Bruce J KirengaLevicatus MugenyiMarina Sánchez-RicoHenry S Kyobe BosaWinters MuttambaRaymond MugumeEliya MwesigwaEzra KalimoVicky NyombiIvan SegawaLoryndah Olive NamakulaRogers SekibiraWilberforce KabweruRosemary ByanyimaHellen AanyuPauline Byakika-KibwikaHenry G MwebesaNicolas HoertelWilliam BazeyoPublished in: Molecular psychiatry (2023)
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; χ 2 = 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.
Keyphrases
- coronavirus disease
- sars cov
- open label
- major depressive disorder
- obsessive compulsive disorder
- cardiovascular events
- patient reported
- clinical trial
- bipolar disorder
- respiratory syndrome coronavirus
- healthcare
- end stage renal disease
- ejection fraction
- palliative care
- chronic kidney disease
- squamous cell carcinoma
- prognostic factors
- radiation therapy
- randomized controlled trial
- young adults
- pregnant women
- adipose tissue
- coronary artery disease
- peritoneal dialysis
- phase iii
- insulin resistance
- metabolic syndrome
- phase ii study
- rectal cancer
- combination therapy
- pregnancy outcomes