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All Studies   Meta Analysis    Recent:   

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., Molecular Psychiatry, doi:10.1038/s41380-023-02004-3
Mar 2023  
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0 0.5 1 1.5 2+ Mortality 68% Improvement Relative Risk Symptom resolution 53% Fluvoxamine  Kirenga et al.  LATE TREATMENT Is late treatment with fluvoxamine beneficial for COVID-19? Prospective study of 316 patients in Uganda (Dec 2021 - Feb 2022) Lower mortality (p<0.0001) and improved recovery (p=0.04) c19early.org Kirenga et al., Molecular Psychiatry, Mar 2023 Favors fluvoxamine Favors control
26th treatment shown to reduce risk in November 2021
 
*, now known with p = 0.00014 from 21 studies, recognized in 3 countries.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,200+ studies for 70+ treatments. c19early.org
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.
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.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Kirenga et al., 3 Mar 2023, prospective, Uganda, peer-reviewed, 19 authors, study period December 2021 - February 2022. Contact: brucekirenga@yahoo.co.uk.
This PaperFluvoxamineAll
Association of fluvoxamine with mortality and symptom resolution among inpatients with COVID-19 in Uganda: a prospective interventional open-label cohort study
Bruce J Kirenga, Levicatus Mugenyi, Marina Sánchez-Rico, Henry Kyobe, Winters Muttamba, Raymond Mugume, Eliya Mwesigwa, Ezra Kalimo, Vicky Nyombi, Ivan Segawa, Loryndah Olive Namakula, Rogers Sekibira, Wilberforce Kabweru, Rosemary Byanyima, Hellen Aanyu, Pauline Byakika-Kibwika, Henry G Mwebesa, Nicolas Hoertel, William Bazeyo
Molecular Psychiatry, doi:10.1038/s41380-023-02004-3
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; 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.
AUTHOR CONTRIBUTIONS Concept and design: BJK; Funding acquisition: BJK and WB; Acquisition of data: RM, EM, EK, VN, LON, RS, WK and HA; Administrative, technical, or material support: WM, IS, HK, RB and HGM; Supervision: BJK and WM; Critical revision of the manuscript: BJK, LM, MSR, NH, WM, PBK and WB; Statistical analysis: BJK, LM, MSR and NH. COMPETING INTERESTS NH is an inventor on a patent application related to methods of treating COVID-19 (FIASMA antidepressants), filled by Assistance Publique-Hopitaux de Paris in France. The other authors have no conflicts of interest related to this work to declare. ETHICAL APPROVAL Compassionate use approval of fluvoxamine for the treatment of COVID-19 was obtained from the Ministry of Health of Uganda (clearance reference no. ADM.180/O1 dated 2nd January 2022). All patients were informed that this medication was under evaluation by health authorities. Patients willing to be treated with this medication gave verbal informed consent. All data used in this study were collected as part of routine care. ADDITIONAL INFORMATION Supplementary information The online version contains supplementary material available at https://doi.org/10.1038/s41380-023-02004-3. Correspondence and requests for materials should be addressed to Bruce J. Kirenga. Reprints and permission information is available at http://www.nature.com/ reprints Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and..
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Springer; New York, USA; 2000.', 'DOI': '10.1007/978-1-4757-3294-8'}, { 'key': '2004_CR62', 'doi-asserted-by': 'publisher', 'first-page': '515', 'DOI': '10.1093/biomet/81.3.515', 'volume': '81', 'author': 'PM Grambsch', 'year': '1994', 'unstructured': 'Grambsch PM, Therneau TM. Proportional hazards tests and diagnostics ' 'based on weighted residuals. Biometrika. 1994;81:515–26.', 'journal-title': 'Biometrika.'}, { 'key': '2004_CR63', 'unstructured': 'R Core Team. R: a language and environment for statistical computing. R ' 'Foundation for Statistical Computing. Auckland, New Zealand; 2022. ' 'https://www.R-project.org/.'}, { 'key': '2004_CR64', 'doi-asserted-by': 'publisher', 'first-page': 'e6', 'DOI': '10.1192/bjo.2021.1053', 'volume': '8', 'author': 'CL Clelland', 'year': '2021', 'unstructured': 'Clelland CL, Ramiah K, Steinberg L, Clelland JD. Analysis of the impact ' 'of antidepressants and other medications on COVID-19 infection risk in a ' 'chronic psychiatric in-patient cohort. BJPsych Open. 2021;8:e6.', 'journal-title': 'BJPsych Open'}, { 'key': '2004_CR65', 'doi-asserted-by': 'publisher', 'first-page': '111437', 'DOI': '10.1016/j.biopha.2021.111437', 'volume': '138', 'author': 'JF Creeden', 'year': '2021', 'unstructured': 'Creeden JF, Imami AS, Eby HM, Gillman C, Becker KN, Reigle J, et al. ' 'Fluoxetine as an anti-inflammatory therapy in SARS-CoV-2 infection. ' 'Biomed Pharmacother. 2021;138:111437.', 'journal-title': 'Biomed Pharmacother'}, { 'key': '2004_CR66', 'doi-asserted-by': 'publisher', 'first-page': 'e333', 'DOI': '10.1016/S2214-109X(21)00588-X', 'volume': '10', 'author': 'G Reis', 'year': '2022', 'unstructured': 'Reis G, Mills E. Fluvoxamine for the treatment of COVID-19—author’s ' 'reply. Lancet Glob Health. 2022;10:e333.', 'journal-title': 'Lancet Glob Health'}], 'container-title': 'Molecular Psychiatry', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://www.nature.com/articles/s41380-023-02004-3.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41380-023-02004-3', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://www.nature.com/articles/s41380-023-02004-3.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 3, 3]], 'date-time': '2023-03-03T10:05:59Z', 'timestamp': 1677837959000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.nature.com/articles/s41380-023-02004-3'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 3, 3]]}, 'references-count': 66, 'alternative-id': ['2004'], 'URL': 'http://dx.doi.org/10.1038/s41380-023-02004-3', 'relation': {}, 'ISSN': ['1359-4184', '1476-5578'], 'subject': ['Cellular and Molecular Neuroscience', 'Psychiatry and Mental health', 'Molecular Biology'], 'container-title-short': 'Mol Psychiatry', 'published': {'date-parts': [[2023, 3, 3]]}, 'assertion': [ { 'value': '17 November 2022', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '8 February 2023', 'order': 2, 'name': 'revised', 'label': 'Revised', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '15 February 2023', 'order': 3, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '3 March 2023', 'order': 4, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': 'NH is an inventor on a patent application related to methods of treating ' 'COVID-19 (FIASMA antidepressants), filled by Assistance Publique-Hopitaux de ' 'Paris in France. The other authors have no conflicts of interest related to ' 'this work to declare.', 'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}, { 'value': 'Compassionate use approval of fluvoxamine for the treatment of COVID-19 was ' 'obtained from the Ministry of Health of Uganda (clearance reference no. ' 'ADM.180/O1 dated 2nd January 2022). All patients were informed that this ' 'medication was under evaluation by health authorities. Patients willing to be ' 'treated with this medication gave verbal informed consent. All data used in ' 'this study were collected as part of routine care.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethical approval'}}]}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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