Lenze 2020
Study characteristics
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Methods |
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Trial design: randomised, double-blind, placebo-controlled, remote design
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Type of publication: journal publication
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Setting: non-hospitalised outpatients
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Recruitment dates: April to August 2020
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Country: USA
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Language: English
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Number of centres: 2
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Trial registration number: NCT04342663
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Date of trial registration: 8 April 2020
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Participants |
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Number of participants (randomised/analysed): 181/152 (115 completed 15-day assessment)
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Age (median, years): fluvoxamine group: 46 (range 20 to 75); control group: 45 (range 21 to 69)
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Gender (males, n (%)): fluvoxamine group: 24 (30); control group: 19 (26)
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Severity of condition according to study definition: non-hospitalised adults with confirmed COVID-19
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Comorbidities: asthma, hypertension, diabetes, high cholesterol, hyperthyroidism, anxiety, osteoarthritis or rheumatoid arthritis, depression
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Virus detection performed at baseline (RT-PCR positive at baseline, %): 100%
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Inclusion criteria
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outpatients (age 18 and older)
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proven SARS-CoV-2 positive (per lab or physician report)
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currently symptomatic, with at least 1 of the following symptoms: fever, cough, myalgia, mild dyspnoea, diarrhoea, vomiting, anosmia (inability to smell), ageusia (inability to taste), sore throat
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Exclusion criteria
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illness severe enough to require hospitalisation or already meeting study’s primary endpoint for clinical worsening
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unstable medical comorbidities (including, but not limited to, severe underlying lung disease)
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decompensated cirrhosis
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congestive heart failure (stage 3 or 4)
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immunocompromised (solid organ transplant, BMT, AIDS, on biologics and/or high dose steroids (> 20 mg prednisone per day))
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currently taking chloroquine, hydroxychloroquine, azithromycin or colchicine.
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Interventions |
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Details of interventions for relevant arms
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type and dose: fluvoxamine 50 mg (initial dose), then 100 mg (2 times daily, for 2 days as tolerated), then 100 mg (3 times daily, through day 15)
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route of administration: oral
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Treatment details of a control group (e.g. type, dose, route of administration)
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Concomitant medications: all patients received standard care (which was not further defined)
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Duration of follow-up: 15 days (after randomisation)
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Treatment cross-overs: none
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Outcomes |
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Notes |
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Date of Publication: 12 November 2020
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Assessment: remotely
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Sponsorship source: Taylor Family Institute for Innovative Psychiatric Treatment and Center for Brain Research in Mood Disorders(Washington University), COVID-19 Early Treatment Fund, Bantly Foundation, and the National Institutes of Health
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Conflicts of interest
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Dr Lenze reported receiving grants from the Patient-Centered Outcomes Research Institute, Takeda, Alkermes, Janssen, Acadia, and the Barnes Jewish Hospital Foundation; and receiving consulting fees from Janssen and Jazz Pharmaceuticals;
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Dr Zorumski reported being on the scientific advisory board for and having stock and stock options with Sage Therapeutics, and receiving personal fees from CME Outfitters and JAMA Psychiatry;
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Dr Nicol reported receiving grants from Alkermes, the Center for Brain Research in Mood Disorders, the Center for Diabetes Translational Research, the Institute for Public Health, the McDonnell Center for Neuroscience, and the Barnes Jewish Hospital Foundation; and serving as a consultant to Sunovion, Alkermes, and Elira;
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Mr Miller reported receiving research funding from the Patient-Centered Outcomes Research Institute;
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Dr Avidan reported receiving grants from the COVID-19 Therapeutics Accelerator.
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Ethics approval: approved by the institutional review board at Washington University in St Louis
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Correspondence with the study authors: request sent (see Table 1)
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