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0 0.5 1 1.5 2+ Hospitalization 55% Improvement Relative Risk Progression, C19 pneu.. 68% Progression -10% Recovery -4% post-hoc primary Clinical progression, day 7 -28% Clinical progression, day.. -17% Clinical progression.. (b) -46% McCarthy et al. NCT04885530 ACTIV-6 Fluvoxamine RCT LATE Favors fluvoxamine Favors control
Fluvoxamine for Outpatient Treatment of COVID-19: A Decentralized, Placebo-controlled, Randomized, Platform Clinical Trial
McCarthy et al., medRxiv, doi:10.1101/2022.10.17.22281178 (Preprint), ACTIV-6, NCT04885530 (history)
18 Oct 2022    Source   PDF   Share   Tweet
RCT low-risk outpatients with very late treatment (median 5 days, 20% ≥8 days) in the USA, showing no significant differences with low-dose fluvoxamine treatment.
Many of the issues noted for the ivermectin arm [Naggie] also apply to this arm, for example none of the pre-specified outcomes have been reported []. In the ivermectin paper the abstract refers to the main post-hoc outcome as the "main outcome", this wording has been updated to "primary outcome" for fluvoxamine.
eFigure 4 shows efficacy continuously declining over time, which may be due to lower severity as the virus evolves. Treatment delay was up to 13 days (eFigure 1). Severe dyspnea at baseline was more common for fluvoxamine (6/586 vs. 3/533, eTable 1).
Authors state that the median treatment delay (5 days) is at the upper limit of the "recommend (sic) start of antiviral medicines (≤5 days)". There is no reference and it's unclear who recommends such late treatment.
Fluvoxamine 50mg twice daily.
risk of hospitalization, 55.0% lower, RR 0.45, p = 0.53, treatment 1 of 670 (0.1%), control 2 of 607 (0.3%), NNT 555, day 28.
risk of progression, 67.6% lower, RR 0.32, p = 0.48, treatment 0 of 615 (0.0%), control 1 of 565 (0.2%), NNT 565, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), C19 pneumonia, eTable 2.
risk of progression, 10.0% higher, RR 1.10, p = 0.75, treatment 26 of 670 (3.9%), control 23 of 607 (3.8%), adjusted per study, urgent or emergency care visits, hospitalizations, or death.
risk of no recovery, 4.2% higher, HR 1.04, p = 0.45, treatment 674, control 614, inverted to make HR<1 favor treatment, post-hoc primary outcome.
clinical progression, 28.0% higher, OR 1.28, p = 0.34, treatment 670, control 607, mid-recovery, day 7, RR approximated with OR.
clinical progression, 17.0% higher, OR 1.17, p = 0.68, treatment 670, control 607, day 14, RR approximated with OR.
clinical progression, 46.0% higher, OR 1.46, p = 0.16, treatment 670, control 607, day 28, RR approximated with OR.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
McCarthy et al., 18 Oct 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, mean age 48.5, 27 authors, study period 6 August, 2021 - 27 May, 2022, average treatment delay 5.0 days, trial NCT04885530 (history) (ACTIV-6).
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This PaperFluvoxamineAll
Late treatment
is less effective
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