Episode Details

Common antidepressant, $4 per course and it works Effect of early treatment with fluvoxamine on risk of emergency care and hospitalisation among patients with COVID-19: the TOGETHER randomised, platform clinical trial https://clinicaltrials.gov/ct2/show/NCT04727424 https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00448-4/fulltext https://www.togethertrial.com Background Potential therapeutic role of fluvoxamine TOGETHER trial for acutely symptomatic patients To assess the efficacy of fluvoxamine versus placebo In preventing hospitalisation Methods Placebo-controlled Randomised Double blind Adaptive platform trial (Factoring in analyses at key points So study design parameters like sample size, dosage, or patient selection can be adjusted accordingly) https://www.parexel.com/experience/adaptive-flexible-trials?KW=adaptive%20trial%20design&AG=%7Badgroup%7D&CS=MSS&utm_source=google&utm_medium=paid&utm_campaign=mss&utm_term=adaptive%20trial%20design&utm_content=106310559248&gclid=CjwKCAjw2vOLBhBPEiwAjEeK9t9AW3N8ysMeIkLgKabG5MRPEtJD9EJsq8hzBhnQ0ztDLPPUm5gppBoCe_oQAvD_BwE High-risk symptomatic Brazilian adults Age ranges and 58% female Confirmed positive for SARS-CoV-2 Within 7 days from first symptoms or diagnosis Patients from 11 clinical sites in Brazil Patients were randomly assigned (1:1) Fluvoxamine (100 mg twice daily for 10 days), n = 741 Placebo, n = 756 Primary outcome Hospitalisation, retention or transfer Up to 28 days post-random assignment Findings, Jan 20 to Aug 5, 2021 The proportion of patients observed in a COVID-19 emergency setting for more than 6 h Or transferred to a teritary hospital due to COVID-19 (87%) Lower for the fluvoxamine group compared with placebo Fluvoxamine group 79 [11%] of 741 Placebo group 119 [16%] of 756 Relative risk 0·68 95% credible interval, 0·52–0·88 Probability of superiority, 99·8% Fluvoxamine group 17 deaths Placebo group 25 deaths Odds ratio [OR] 0·68 95% credible interval, 0·36–1·27 No significant differences in number of treatment emergent adverse events among patients in the fluvoxamine and placebo groups Fluvoxamine group 84 stopped taking Placebo group 64 The absolute number of serious adverse events associated with fluvoxamine was lower than for placebo this might reflect the modulatory effect of fluvoxamine on systemic inflammation Mechanism? Anti-inflammatory Preventing cytokine storm Antiplatelet activity Increasing plasma levels of melatonin It is now crucial to establish whether a class effect exists? Interactions with vaccines, improved effect? stopped taking https://bnf.nice.org.uk/drug/fluvoxamine-maleate.html For Adult Initially 50–100 mg daily

Learn more about your ad choices. Visit megaphone.fm/adchoices