Results From the COVID-OUT Trial, a Phase-3 trial of Outpatient Treatment for Covid-19 Using Metformin, Ivermectin, and Fluvoxamine
et al. (Preprint), COVID-OUT, NCT04510194 (history)
Results for COVID-OUT were reported in a presentation, however
they are not currently available due to a news embargo. There were no
statistically significant results for metformin, ivermectin, or fluvoxamine,
except for a post-hoc metformin composite. Null results are expected based on
the trial design and size (with metformin having higher power and a greater
chance of showing a result despite the design).
We note that embargo and delay of clinical trial results during
a pandemic is not consistent with a goal of minimizing mortality and
morbidity, but is consistent with a goal of maximizing press for a trial
designed to produce a null result.
Trial outcomes were changed on January 20, 2022
[clinicaltrials.gov],
and again on March 2, 2022
[clinicaltrials.gov (B)].
COVIDOUT.
Medication delivery varied significantly over the trial. In
this presentation [vimeo.com], author indicates that
delivery was initially local, later via FedEx, was much slower in August,
there were delays due to team bandwidth issues, and they only realized they
could use FedEx same day delivery in September.
Bramante et al., 7/8/2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, preprint, 3 authors, trial NCT04510194 (history) (COVID-OUT).
Late treatment
is less effective
is less effective
Please send us corrections, updates, or comments. Vaccines and
treatments are both valuable and complementary. All practical, effective, and
safe means should be used. No treatment, vaccine, or intervention is 100%
available and effective for all current and future variants. Denying the
efficacy of any method increases mortality, morbidity, collateral damage, and
the risk of endemic status. 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.