Dataset Information

Prospective Cohort of Fluvoxamine for Early Treatment of Coronavirus Disease 19.

ABSTRACT: We report a real-world experience using fluvoxamine for coronavirus disease 19 (COVID-19) in a prospective cohort in the setting of a mass outbreak. Overall, 65 persons opted to receive fluvoxamine (50 mg twice daily) and 48 declined. Incidence of hospitalization was 0% (0 of 65) with fluvoxamine and 12.5% (6 of 48) with observation alone. At 14 days, residual symptoms persisted in 0% (0 of 65) with fluvoxamine and 60% (29 of 48) with observation.

SUBMITTER: Seftel D

PROVIDER: S-EPMC7888564 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Prospective Cohort of Fluvoxamine for Early Treatment of Coronavirus Disease 19.

Seftel David D Boulware David R DR

Open forum infectious diseases 20210201 2

We report a real-world experience using fluvoxamine for coronavirus disease 19 (COVID-19) in a prospective cohort in the setting of a mass outbreak. Overall, 65 persons opted to receive fluvoxamine (50 mg twice daily) and 48 declined. Incidence of hospitalization was 0% (0 of 65) with fluvoxamine and 12.5% (6 of 48) with observation alone. At 14 days, residual symptoms persisted in 0% (0 of 65) with fluvoxamine and 60% (29 of 48) with observation. ...[more]

PMID: 33623808

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Project description:BackgroundPrevious trials have demonstrated the effects of fluvoxamine alone and inhaled budesonide alone for prevention of disease progression among outpatients with COVID-19.ObjectiveTo determine whether the combination of fluvoxamine and inhaled budesonide would increase treatment effects in a highly vaccinated population.DesignRandomized, placebo-controlled, adaptive platform trial. (ClinicalTrials.gov: NCT04727424).Setting12 clinical sites in Brazil.ParticipantsSymptomatic adults with confirmed SARS-CoV-2 infection and a known risk factor for progression to severe disease.InterventionPatients were randomly assigned to either fluvoxamine (100 mg twice daily for 10 days) plus inhaled budesonide (800 mcg twice daily for 10 days) or matching placebos.MeasurementsThe primary outcome was a composite of emergency setting retention for COVID-19 for more than 6 hours, hospitalization, and/or suspected complications due to clinical progression of COVID-19 within 28 days of randomization. Secondary outcomes included health care attendance (defined as hospitalization for any cause or emergency department visit lasting >6 hours), time to hospitalization, mortality, patient-reported outcomes, and adverse drug reactions.ResultsRandomization occurred from 15 January to 6 July 2022. A total of 738 participants were allocated to oral fluvoxamine plus inhaled budesonide, and 738 received placebo. The proportion of patients observed in an emergency setting for COVID-19 for more than 6 hours or hospitalized due to COVID-19 was lower in the treatment group than the placebo group (1.8% [95% credible interval {CrI}, 1.1% to 3.0%] vs. 3.7% [95% CrI, 2.5% to 5.3%]; relative risk, 0.50 [95% CrI, 0.25 to 0.92]), with a probability of superiority of 98.7%. No relative effects were found between groups for any of the secondary outcomes. More adverse events occurred in the intervention group than the placebo group, but no important differences between the groups were detected.LimitationLow event rate overall, consistent with contemporary trials in vaccinated populations.ConclusionTreatment with oral fluvoxamine plus inhaled budesonide among high-risk outpatients with early COVID-19 reduced the incidence of severe disease requiring advanced care.Primary funding sourceLatona Foundation, FastGrants, and Rainwater Charitable Foundation.

Project description:BackgroundAcute gastrointestinal infections can lead to post-infectious irritable bowel syndrome (PI-IBS). Moreover, coronavirus disease (COVID-19) is related to long-term gastrointestinal sequelae. In this study, the frequency, disease spectrum, and risk factors for post-infection functional gastrointestinal disease (PI-FGID) in COVID-19 patients and healthy controls were prospectively examined.MethodsValidated Rome III and Rome IV questionnaires and limited objective assessment were used to assess the incidence of PI-FGID in 190 COVID-19 patients, and 160 healthy controls prospectively followed for 1, 3, and 6 months.ResultsSix(3.2%), 1(0.5%), 3(1.6%), 5(2.6%), 6(3.2%)COVID-19 patients had diarrhea, abdominal pain, constipation, dyspepsia and their overlap at 1 month, respectively, while 4(2.1%), 1(0.5%), 4(2.1%), 4(2.1%), and 6(3.2%)COVID-19 patients had diarrhea, abdominal pain, constipation, dyspepsia and their overlap at three months, respectively. Furthermore, 2(1.3%), 4(2.5%), and 3(1.9%)healthy controls developed constipation, dyspepsia, and their overlap at one month, respectively (P = 0.193), while 2(1.3%), 4(2.5%), and 2(1.3%)healthy controls developed constipation, dyspepsia and their overlap at three months, respectively (P = 0.286). FGIDs incidence was higher among COVID-19 patients(8.9%) than in healthy controls(3.1%) at 6-month follow-up (P = 0.025). Moreover, 7 (3.7%), 5 (2.6%), 3 (1.6%), and 2 (1.1%) COVID-19 patients developed IBS, functional dyspepsia(FD), functional diarrhea(FDr), functional constipation(FC)at six months, respectively, while only 2 (1.3%) and 3 (1.9%) healthy controls developed IBS and FD at six months, respectively. Notably, gastrointestinal(GI)symptoms at onset were the independent risk factors for post-COVID-19 FGIDs at six months.ConclusionsCOVID-19 increases new-onset PI-FGID at six months compared with healthy controls. GI symptom at the onset of COVID-19 is an independent risk factor for post-COVID-19 FGIDs.

Dataset Information

Prospective Cohort of Fluvoxamine for Early Treatment of Coronavirus Disease 19.

Publications

Prospective Cohort of Fluvoxamine for Early Treatment of Coronavirus Disease 19.

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