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Impact of fluvoxamine on outpatient treatment of COVID-19 in Honduras in a prospective observational real-world study

Pineda et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.1054644 (date from preprint)
Oct 2022  
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Mortality 94% Improvement Relative Risk Oxygen therapy 73% Hospitalization 51% Hospitalization time -71% Fluvoxamine  Pineda et al.  EARLY TREATMENT Is early treatment with fluvoxamine beneficial for COVID-19? Prospective study of 657 patients in Honduras (Nov 2020 - Jan 2022) Lower mortality (p=0.011) and lower oxygen therapy (p=0.00016) c19early.org Pineda et al., Frontiers in Pharmacology, Oct 2022 Favorsfluvoxamine Favorscontrol 0 0.5 1 1.5 2+
27th treatment shown to reduce risk in November 2021, now with p = 0.00014 from 21 studies, recognized in 3 countries.
No treatment is 100% effective. Protocols combine treatments.
5,100+ studies for 112 treatments. c19early.org
Prospective study of 657 COVID+ outpatients in Honduras, 594 accepting fluvoxamine treatment, showing significantly lower mortality and hospitalization with treatment.
risk of death, 94.0% lower, RR 0.06, p = 0.01, treatment 1 of 594 (0.2%), control 4 of 63 (6.3%), NNT 16, adjusted per study.
risk of oxygen therapy, 73.0% lower, RR 0.27, p < 0.001, treatment 15 of 594 (2.5%), control 13 of 63 (20.6%), NNT 5.5, adjusted per study.
risk of hospitalization, 51.0% lower, RR 0.49, p = 0.04, treatment 23 of 594 (3.9%), control 11 of 63 (17.5%), NNT 7.4, adjusted per study.
hospitalization time, 71.4% higher, relative time 1.71, p = 0.08, treatment 23, control 11.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Pineda et al., 4 Oct 2022, prospective, Honduras, peer-reviewed, mean age 48.1, 24 authors, study period November 2020 - January 2022. Contact: anupamsekhon@yahoo.com.
This PaperFluvoxamineAll
Impact of fluvoxamine on outpatient treatment of COVID-19 in Honduras in a prospective observational real-world study
Estela Pineda, Jarmanjeet Singh, Miguel Vargas Pineda, Jose Garay Umanzor, Fernando Baires, Luis G Benitez, Cesar Burgos, Anupamjeet Kaur Sekhon, Nicole Crisp, Anita S Lewis, Jana Radwanski, Marco Bermudez, Karen Sanchez Barjun, Oscar Diaz, Elsa Palou, Rossany E Escalante, Carlos Isai Hernandez, Mark L Stevens, Deke Eberhard, Manuel Sierra, Tito Alvarado, Omar Videa, Miguel Sierra-Hoffman, Fernando Valerio-Pascua
Frontiers in Pharmacology, doi:10.3389/fphar.2022.1054644
Background: The COVID-19 pandemic has impacted millions of lives globally. While COVID-19 did not discriminate against developed or developing nations, it has been a significant challenge for third world countries like Honduras to have widespread availability of advanced therapies. The concept of early treatment was almost unheard of when early outpatient treatments utilizing repurposed drugs in Latin American countries began showing promising results. One such drug is fluvoxamine, which has shown tremendous potential in two major studies. As a direct result, fluvoxamine was added to the standard of care in a major medical center outpatient COVID-19 clinic.
Ethics statement The studies involving human participants were reviewed and approved by Institutional Review Board (IRB) of the Hospital Centro Médico Sanpedrano and the Ethics committee of investigation of infectious and zoonotic disease masters of the Universidad Nacional Autónoma de Honduras. The patients/ participants provided their written informed consent to participate in this study. Author contributions All authors listed have made a substantial, direct, and intellectual contribution to the work and approved it for publication. Conflict of interest The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.
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{ 'indexed': {'date-parts': [[2023, 3, 21]], 'date-time': '2023-03-21T14:30:49Z', 'timestamp': 1679409049267}, 'reference-count': 48, 'publisher': 'Frontiers Media SA', 'license': [ { 'start': { 'date-parts': [[2022, 11, 30]], 'date-time': '2022-11-30T00:00:00Z', 'timestamp': 1669766400000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'https://creativecommons.org/licenses/by/4.0/'}], 'content-domain': {'domain': ['frontiersin.org'], 'crossmark-restriction': True}, 'abstract': '<jats:p><jats:bold>Background:</jats:bold> The COVID-19 pandemic has impacted millions of ' 'lives globally. While COVID-19 did not discriminate against developed or developing nations, ' 'it has been a significant challenge for third world countries like Honduras to have ' 'widespread availability of advanced therapies. The concept of early treatment was almost ' 'unheard of when early outpatient treatments utilizing repurposed drugs in Latin American ' 'countries began showing promising results. One such drug is fluvoxamine, which has shown ' 'tremendous potential in two major studies. As a direct result, fluvoxamine was added to the ' 'standard of care in a major medical center outpatient COVID-19 ' 'clinic.</jats:p><jats:p><jats:bold>Methods:</jats:bold> This is a prospective observational ' 'study performed at the Hospital Centro Médico Sampedrano (CEMESA) in San Pedro Sula, Cortes, ' 'Honduras in the COVID-19 outpatient clinic. All patients were at least 15\xa0years of age who ' 'had presented with mild or moderate signs and symptoms of COVID-19, and who also had a ' 'documented positive SARS-CoV-2 antigen or Reverse Transcription Polymerase Chain Reaction ' '(RT-PCR) were included in the study. These patients then were all prescribed fluvoxamine. The ' 'cohort of patients who decided to take fluvoxamine were compared for primary endpoints of ' 'mortality and hospitalization risk to the cohort who did not take fluvoxamine. Patients were ' 'then monitored for 30\xa0days with the first follow up at 7\xa0days and the second follow up ' 'at 10–14\xa0days of symptom onset. Categorical variables were compared by Pearson Chi-square ' 'test. The Relative risk was calculated using regression models. Continuous variables were ' 'compared by t-test and Wilcoxon rank-sum ' 'tests.</jats:p><jats:p><jats:bold>Results:</jats:bold> Out of total 657 COVID-19 cases, 594 ' 'patients took fluvoxamine and 63 did not take fluvoxamine. A total of five patients (0.76 ' 'percent) died, with only one death occurring in the fluvoxamine group. Patients who received ' 'fluvoxamine had a significantly lower relative risk of mortality (RR 0.06, ' '<jats:italic>p</jats:italic> 0.011, 95% CI 0.007–0.516). There was a lower relative risk of ' 'hospitalization in the patients who in the fluvoxamine group. (−10 vs. 30 hospitalizations, ' 'RR 0.49, <jats:italic>p</jats:italic> = 0.035, 95% CI 0.26–0.95). There was 73 percent ' 'reduction in relative risk of requiring oxygen in the fluvoxamine group (RR 0.27, ' '<jats:italic>p</jats:italic> &amp;lt; 0.001, 95% CI 0.14–0.54 Mean lymphocytes count on the ' 'first follow-up visit was significantly higher in the fluvoxamine group (1.72 vs. 1.38, Δ ' '0.33, <jats:italic>p</jats:italic> 0.007, CI ' '0.09–0.58).</jats:p><jats:p><jats:bold>Conclusion:</jats:bold> The results of our study ' 'suggest that fluvoxamine lowers the relative risk of death, hospitalization, and oxygen ' 'requirement in COVID 19 patients.</jats:p>', 'DOI': '10.3389/fphar.2022.1054644', 'type': 'journal-article', 'created': { 'date-parts': [[2022, 11, 30]], 'date-time': '2022-11-30T06:16:23Z', 'timestamp': 1669788983000}, 'update-policy': 'http://dx.doi.org/10.3389/crossmark-policy', 'source': 'Crossref', 'is-referenced-by-count': 1, 'title': 'Impact of fluvoxamine on outpatient treatment of COVID-19 in Honduras in a prospective ' 'observational real-world study', 'prefix': '10.3389', 'volume': '13', 'author': [ {'given': 'Estela', 'family': 'Pineda', 'sequence': 'first', 'affiliation': []}, {'given': 'Jarmanjeet', 'family': 'Singh', 'sequence': 'additional', 'affiliation': []}, {'given': 'Miguel Vargas', 'family': 'Pineda', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jose Garay', 'family': 'Umanzor', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fernando', 'family': 'Baires', 'sequence': 'additional', 'affiliation': []}, {'given': 'Luis G.', 'family': 'Benitez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Cesar', 'family': 'Burgos', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anupamjeet Kaur', 'family': 'Sekhon', 'sequence': 'additional', 'affiliation': []}, {'given': 'Nicole', 'family': 'Crisp', 'sequence': 'additional', 'affiliation': []}, {'given': 'Anita S.', 'family': 'Lewis', 'sequence': 'additional', 'affiliation': []}, {'given': 'Jana', 'family': 'Radwanski', 'sequence': 'additional', 'affiliation': []}, {'given': 'Marco', 'family': 'Bermudez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Karen Sanchez', 'family': 'Barjun', 'sequence': 'additional', 'affiliation': []}, {'given': 'Oscar', 'family': 'Diaz', 'sequence': 'additional', 'affiliation': []}, {'given': 'Elsa', 'family': 'Palou', 'sequence': 'additional', 'affiliation': []}, {'given': 'Rossany E.', 'family': 'Escalante', 'sequence': 'additional', 'affiliation': []}, {'given': 'Carlos Isai', 'family': 'Hernandez', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mark L.', 'family': 'Stevens', 'sequence': 'additional', 'affiliation': []}, {'given': 'Deke', 'family': 'Eberhard', 'sequence': 'additional', 'affiliation': []}, {'given': 'Manuel', 'family': 'Sierra', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tito', 'family': 'Alvarado', 'sequence': 'additional', 'affiliation': []}, {'given': 'Omar', 'family': 'Videa', 'sequence': 'additional', 'affiliation': []}, {'given': 'Miguel', 'family': 'Sierra-Hoffman', 'sequence': 'additional', 'affiliation': []}, {'given': 'Fernando', 'family': 'Valerio-Pascua', 'sequence': 'additional', 'affiliation': []}], 'member': '1965', 'published-online': {'date-parts': [[2022, 11, 30]]}, 'reference': [ { 'key': 'B1', 'doi-asserted-by': 'publisher', 'first-page': '365', 'DOI': '10.1007/978-3-642-38664-0_15', 'article-title': 'Serotonin transporter and serotonin receptors', 'volume': '218', 'author': 'Adnot', 'year': '2013', 'journal-title': 'Handb. 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Pharmacol.', 'published': {'date-parts': [[2022, 11, 30]]}}
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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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