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Fluvoxamine vs Placebo and Clinical Deterioration in Outpatients With Symptomatic COVID-19 A Randomized Clinical Trial
JAMA Network ^ | November 12, 2020 | Eric Lenzi MD, et al

Posted on 12/24/2020 2:19:15 PM PST by absalom01

Key Points Question Does fluvoxamine, a selective serotonin reuptake inhibitor and σ-1 receptor agonist, prevent clinical deterioration in outpatients with acute coronavirus disease 2019 (COVID-19)?

Findings In this randomized trial that included 152 adult outpatients with confirmed COVID-19 and symptom onset within 7 days, clinical deterioration occurred in 0 patients treated with fluvoxamine vs 6 (8.3%) patients treated with placebo over 15 days, a difference that was statistically significant.

Meaning In this preliminary study, adult outpatients with symptomatic COVID-19 treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days; however, determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.

Abstract Importance Coronavirus disease 2019 (COVID-19) may lead to serious illness as a result of an excessive immune response. Fluvoxamine may prevent clinical deterioration by stimulating the σ-1 receptor, which regulates cytokine production.

Objective To determine whether fluvoxamine, given during mild COVID-19 illness, prevents clinical deterioration and decreases the severity of disease.

Design, Setting, and Participants Double-blind, randomized, fully remote (contactless) clinical trial of fluvoxamine vs placebo. Participants were community-living, nonhospitalized adults with confirmed severe acute respiratory syndrome coronavirus 2 infection, with COVID-19 symptom onset within 7 days and oxygen saturation of 92% or greater. One hundred fifty-two participants were enrolled from the St Louis metropolitan area (Missouri and Illinois) from April 10, 2020, to August 5, 2020. The final date of follow-up was September 19, 2020.

Interventions Participants were randomly assigned to receive 100 mg of fluvoxamine (n = 80) or placebo (n = 72) 3 times daily for 15 days.

Main Outcomes and Measures The primary outcome was clinical deterioration within 15 days of randomization defined by meeting both criteria of (1) shortness of breath or hospitalization for shortness of breath or pneumonia and (2) oxygen saturation less than 92% on room air or need for supplemental oxygen to achieve oxygen saturation of 92% or greater.

Results Of 152 patients who were randomized (mean [SD] age, 46 [13] years; 109 [72%] women), 115 (76%) completed the trial. Clinical deterioration occurred in 0 of 80 patients in the fluvoxamine group and in 6 of 72 patients in the placebo group (absolute difference, 8.7% [95% CI, 1.8%-16.4%] from survival analysis; log-rank P = .009). The fluvoxamine group had 1 serious adverse event and 11 other adverse events, whereas the placebo group had 6 serious adverse events and 12 other adverse events.

Conclusions and Relevance In this preliminary study of adult outpatients with symptomatic COVID-19, patients treated with fluvoxamine, compared with placebo, had a lower likelihood of clinical deterioration over 15 days. However, the study is limited by a small sample size and short follow-up duration, and determination of clinical efficacy would require larger randomized trials with more definitive outcome measures.

Trial Registration ClinicalTrials.gov Identifier: NCT04342663


TOPICS: Extended News; Government; News/Current Events
KEYWORDS: ccpvirus; chinavirustreatment; covid19; fluvoxamine; luvox; prozac
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To: TennesseeGirl

This isn’t Prozac. Brand name is Luvox. Both are SSRI’s.


21 posted on 12/24/2020 8:07:42 PM PST by absalom01 (You should do your duty in all things. You cannot do more, and you should never wish to do less.)
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To: SecAmndmt

Correct me if I’m wrong, but isn’t the FLCCC’s MATH+ their in-hospital protocol, and their I-MASK+ their early outpatient recommendation?


22 posted on 12/24/2020 8:23:27 PM PST by absalom01 (You should do your duty in all things. You cannot do more, and you should never wish to do less.)
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To: absalom01
This strikes me as different, in that there’s a real, double-blind RCT, published in a JAMA property, and that this was used as an off-label treatment right in ground zero of Covid madness: the San Francisco Bay area.

Yeah, getting someone to do a legit trial on an off label use for a generic drug is a hard sell. Trials are expensive and mostly funded by the pharmaceutical industry, who can recover the cost if the drug is approved. For a drug like Ivermectin, you need a grant or a philanthropist to fund it, as there is no way to recover the cost. The study I linked to on Indomethacin (not Ivermectin) was funded by a philanthropist. Retrospective studies can be informative, or like the Retrospective HCQ study by Didier Raoult, they can be a joke. But they are not a replacement for a legit trial.

23 posted on 12/24/2020 10:16:02 PM PST by ETCM
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To: absalom01

“Correct me if I’m wrong, but isn’t the FLCCC’s MATH+ their in-hospital protocol, and their I-MASK+ their early outpatient recommendation?”

Yep. But didn’t Kory get smeared even before he testified in the last Senate hearing?


24 posted on 12/24/2020 10:46:06 PM PST by SecAmndmt (Aim small, miss small)
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To: absalom01

I am not a doctor or other medical professional, but I can do math quite well, and knew a little about the basics of herd immunity from the early days of computer antivirus protection. So i grasped what you’re saying very early on. Even if the HCQ protocols were only 30% efficacious, that could have dropped Rt, the transmissibility coefficient, down to less than 1.0, and the disease would be sharply reduced and perhaps even die out.

I believe that’s what we’re seeing with India’s numbers.
https://www.worldometers.info/coronavirus/country/india/
Scroll down to the graphs for new cases and deaths in particular. They’ve been doing therapeutic treatment and prophylaxis for months, first with HCQ, now with Ivermectin.

This home treatment kit they’ve made available blows me away:
https://www.rxindia.com/medicines/medicines-by-therapeutic-class/covid-19/ziverdo-kit/
They recommend adding D3 to this kit which has ivermectin, doxycycline, and zinc.

It is criminal that our media and public health edifice aren’t talking about this sort of thing incessantly.


25 posted on 12/24/2020 10:57:44 PM PST by FreedomPoster (Islam delenda est)
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To: ETCM; absalom01

You could do trials for a fraction of what we spend as a society on NIH, CDC, and the like. Name their top three successes in all this. Why are we funding them? I really see them as largely useless in all this. Convince me otherwise.


26 posted on 12/24/2020 11:03:11 PM PST by FreedomPoster (Islam delenda est)
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To: FreedomPoster

The CDC and NIH have been focusing on social justice, LGBTQXYZ health and gun violence for at least the past 2 decades. Public Health and Disease Control are just not a priority anymore.


27 posted on 12/24/2020 11:36:09 PM PST by ETCM
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To: ETCM

I figured that out early in Covid. If you’re bored and wanted to dig thru my posts in March-April, I made some posts where I reported the number of hits searching the CDC web site for Climate Change, Diversity and Transgender. Thousands of hits, and all that content didn’t come cheap in time or money.

They’ve clearly completely lost focus on the public health mission.


28 posted on 12/25/2020 4:23:52 AM PST by FreedomPoster (Islam delenda est)
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To: FreedomPoster

It’s really hard to make comparisons between countries, given the wide variability in data collection and reporting.

India’s an interesting case, with millions of really poor people, but a sophisticated industrial base in sections of the country as well. They recognized early on that they couldn’t afford to wait for gold-standard RCT’s and vaccines, they simply don’t have the medical infrastructure for their ordinary needs, let alone a runaway pandemic. And, they admitted that they could not afford extended western-style “lockdowns”, as people would not simply stay home and not work and starve.

They rolled out HCQ as prophylaxis early on, and started treating people at home with cheap combination therapies as well.

They quickly pivoted to ivermectin when initial data out of Australia showed promise.

They were smart, and more importantly, they were actually focused on solutions, rather than making the CCP virus an excuse for grabbing and consolidating political power, as has been happening in the US.


29 posted on 12/25/2020 11:34:23 AM PST by absalom01 (You should do your duty in all things. You cannot do more, and you should never wish to do less.)
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To: ETCM

That’s what happened with this particular study. A silicon valley tech bro I had never heard of started a fund to finance research into repurposing of off-label, existing FDA approved drugs for COVID. It looks like he hit pay dirt.

And thanks for the link to the Indomethacin. Adding it to the archve.


30 posted on 12/25/2020 11:46:30 AM PST by absalom01 (You should do your duty in all things. You cannot do more, and you should never wish to do less.)
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To: FreedomPoster

I was naïve enough, in March, to think that was what NIH was supposed to be doing.

I mean, it’s not like it’s a novel idea to repurpose an existing, tested drug with a known safety profile to address conditions it wasn’t originally intended for.

And it’s not exactly a novel idea to treat a disease early in its course, before the patient gets so sick he needs to be hospitalized (and saving hospital capacity was the initial sell for the ‘lockdown’.)

And it’s not exactly novel to treat a viral disease with combination therapies.

But the NIH did none of that. They sank all of their vast resources into studies of ‘hail Mary’ therapies for desperately ill patients, and billions for vaccines.

Now, I’m not anti-vax, and finding a way to bring someone back from the brink isn’t a bad thing, either. But the first focus should have been on catching it early and averting hospitalizations.

At least it’s now obvious to everyone that the system is totally corrupt.


31 posted on 12/25/2020 11:52:39 AM PST by absalom01 (You should do your duty in all things. You cannot do more, and you should never wish to do less.)
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To: FreedomPoster

You are right. The shift has been obvious for quite some time, but I assumed they were still doing their actual PH mission. COVID revealed I was wrong. Sadly, it’s not just the CDC and NIH. The vast majority of State and County Public Health Directors have also shifted their focus. Our country’s entire Public Health System has been hijacked to support the far left. The only health issues they care about are for “special” groups.


32 posted on 12/25/2020 12:28:05 PM PST by ETCM
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To: absalom01

Sounds about right. Especially on that last.


33 posted on 12/25/2020 1:37:27 PM PST by FreedomPoster (Islam delenda est)
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To: absalom01

I wish I thought that last was true. I’m not seeing it. None of this stuff is being talked about, reported, being treated as a lesson learned on how not to do things.


34 posted on 12/25/2020 1:40:03 PM PST by FreedomPoster (Islam delenda est)
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To: ETCM
Our country’s entire Public Health System has been hijacked to support the far left. The only health issues they care about are for “special” groups.

Considering the demographics of the actual CV deaths, (not the 200+K) in addition to the hospice and nursing home patients...I wouldn't be surprised to learn that the HIV-faggots aren't also dropping like flies.

35 posted on 12/26/2020 6:34:01 AM PST by ROCKLOBSTER (Trump won the "popular vote". Biden won the digital vote.)
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