Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study
Kirenga et al.,
Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a..,
Molecular Psychiatry, doi:10.1038/s41380-023-02004-3
Prospective study of 316 hospitalized patients in Uganda, 94 receiving fluvoxamine, showing significantly lower mortality and improved recovery with treatment.
risk of death, 68.0% lower, HR 0.32, p < 0.001, treatment 29 of 94 (30.9%), control 126 of 222 (56.8%), NNT 3.9, adjusted for unbalanced covariates, propensity score weighting, Cox proportional hazards.
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symptom resolution, 53.1% lower, HR 0.47, p = 0.04, treatment 94, control 222, inverted to make HR<1 favor treatment, propensity score weighting, Cox proportional hazards, RR approximated with OR.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Kirenga et al., 3 Mar 2023, prospective, Uganda, peer-reviewed, 19 authors, study period December 2021 - February 2022.
Contact:
brucekirenga@yahoo.co.uk.
Abstract: Molecular Psychiatry
ARTICLE
www.nature.com/mp
OPEN
Association of fluvoxamine with mortality and symptom
resolution among inpatients with COVID-19 in Uganda:
a prospective interventional open-label cohort study
✉
Bruce J. Kirenga1,2 , Levicatus Mugenyi 2,3, Marina Sánchez-Rico 4, Henry Kyobe 5, Winters Muttamba2,6, Raymond Mugume2,
2,7
Eliya Mwesigwa , Ezra Kalimo7, Vicky Nyombi7, Ivan Segawa 2, Loryndah Olive Namakula2,7, Rogers Sekibira2, Wilberforce Kabweru7,
Rosemary Byanyima7, Hellen Aanyu 7, Pauline Byakika-Kibwika 1, Henry G. Mwebesa5, Nicolas Hoertel4,8,9 and William Bazeyo10
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© The Author(s) 2023
Prior research suggests that fluvoxamine, a selective serotonin reuptake inhibitor (SSRI) used for the treatment of obsessivecompulsive 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.
Molecular Psychiatry; https://doi.org/10.1038/s41380-023-02004-3
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