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Antiviral effect of high-dose Ivermectin in adults with COVID-19: A proof-of-concept randomized trial
Lancet eClinical Medicine ^ | 07/16/2021 | Alejandro Krolewiecki, Adrián Lifschitz Matías Moragas Marina Travacio Ricardo Valentini Daniel F.

Posted on 07/17/2021 8:10:06 PM PDT by SeekAndFind

Abstract

Background

There are limited antiviral options for the treatment of patients with COVID-19. Ivermectin (IVM), a macrocyclic lactone with a wide anti-parasitary spectrum, has shown potent activity against SARS-CoV-2 in vitro. This study aimed at assessing the antiviral effect of IVM on viral load of respiratory secretions and its relationship with drug concentrations in plasma.

Methods

Proof-of-concept, pilot, randomized, controlled, outcome-assessor blinded trial to evaluate antiviral activity of high-dose IVM in 45 COVID-19 hospitalized patients randomized in a 2:1 ratio to standard of care plus oral IVM at 0·6 mg/kg/day for 5 days versus standard of care in 4 hospitals in Argentina. Eligible patients were adults with RT-PCR confirmed SARS-CoV-2 infection within 5 days of symptoms onset. The primary endpoint was the difference in viral load in respiratory secretions between baseline and day-5, by quantitative RT-PCR. Concentrations of IVM in plasma were measured. Study registered at ClinicalTrials.gov: NCT04381884.

Findings

45 participants were recruited (30 to IVM and 15 controls) between May 18 and September 9, 2020. There was no difference in viral load reduction between groups but a significant difference was found in patients with higher median plasma IVM levels (72% IQR 59–77) versus untreated controls (42% IQR 31–73) (p = 0·004). Mean ivermectin plasma concentration levels correlated with viral decay rate (r: 0·47, p = 0·02). Adverse events were similar between groups. No differences in clinical evolution at day-7 and day-30 between groups were observed.

Interpretation

A concentration dependent antiviral activity of oral high-dose IVM was identified at a dosing regimen that was well tolerated. Large trials with clinical endpoints are necessary to determine the clinical utility of IVM in COVID-19.

Research in context

Evidence before this study

The potential role of ivermectin against SARS-CoV-2 was first reported in April 2020 when an Australian group published in-vitro results. Since then, multiple opinion papers and a few studies tried to understand the meaning of those results and utility of ivermectin in COVID-19. Mostly observational reports suggest a potential activity that needs confirmation through randomized controlled trials.

Added value of this study

Our study contributes evidence of the antiviral activity of ivermectin against SARS-CoV-2 in patients with COVID-19 through a randomized, controlled, outcome-assessor blinded clinical trial with innovative analyses that include the use of quantitative viral load determinations and measurement of ivermectin plasma levels, which allow an in-depth interpretation of the data and the identification of ivermectin systemic concentrations needed for a significant antiviral effect. The use of an untreated control group highlights the need for controlled trials and on the viral load dynamics in the natural history of COVID-19. Finally, we also add further information on the safety of high dose ivermectin.

Implications of all the available evidence

A concentration dependent antiviral effect of ivermectin in COVID-19 was identified, with significant reductions in SARS-CoV-2 viral load in respiratory secretions among patients achieving high systemic ivermectin concentration compared to untreated controls. These results, that did not show toxicity related to the use of high dose ivermectin, provide evidence of the antiviral effect and support the design of trials to investigate the clinical implications of our findings. Further exploration of the factors involved in the oral bioavailability of ivermectin are also warranted.


TOPICS: Health/Medicine; Science; Society
KEYWORDS: antiviral; covid19; ivermectin; vaccine
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To: Mom MD

RE: Even if it does which is not proven yet it has a long way to go to beat monoclonal antibody therapy and steroids

1) You do have to check in to a Doctor to get Regeneron, you can’t treat yourself with it ( it is an intraveneously injected drug ).

2) This should be STANDARD treatment for every Covid positive patient, i.e., they should not have to ask for it. And it should be OUTPATIENT as well. If me or my family had Covid and I visited a Doctor, it should be the first drug provided for us.

3) Regarding decadron, do you need a prescription for it? If not, do you have to SPECIFICALLY Ask your doctor to prescibe it, or will doctors know?


21 posted on 07/17/2021 8:55:59 PM PDT by SeekAndFind
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To: Truthoverpower

Bkmk


22 posted on 07/17/2021 9:00:44 PM PDT by ptsal (Vote R.E.D. >>>Remove Every Democrat ***)
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To: Mom MD

RE: it may reduce viral load in respiratory secretions but it made no clinical difference according to this study.

The study also states thusly: Further exploration of the factors involved in the oral bioavailability of ivermectin are also warranted.

Therefore, the right POLICY by the FDA or WHO would be to allow doctors anywhere to work with patients under INFORMED CONSENT (e.g, showing them studies like this one ). Not ban the drug and threaten doctors with delicensing if they choose to prescribe it.

This is especially important in places where Monoclonal Antibodies are not available.


23 posted on 07/17/2021 9:03:19 PM PDT by SeekAndFind
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To: SeekAndFind

“.6 mg/kg/day for 5 days”

that’s only slightly higher than the Zelenko protocol at 0.4-0.5mg/kg/day for 5-7 days


24 posted on 07/17/2021 9:26:30 PM PDT by catnipman (Cat Nipman: Vote Republican in 2012 and only be called racist one more time!)
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To: SeekAndFind

monoclonal antibody therapy is only outpatient therapy at this time. Once you are sick enough to meet hospitalization criteria it is no longer an option. I agree it should be the first therapy offered and in many places it is.

Decadron also requires a prescription but should be easily available and is used inpatient and outpatient. Doctors should know to prescribe it but it never hurts to ask. I suppose a lot rides on how much your doctor treats covid but monoclonal antibodies and steroids are first line outpatient therapy for anyone symptomatic with risk factors. As far as I know the monoclonal antibodies are still available at no cost to the patient.


25 posted on 07/17/2021 9:27:55 PM PDT by Mom MD ( )
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To: SeekAndFind

I agree only large scale trials will settle the ivermectin question and it may be a while til we have those. In their world countries where monoclonal anti body therapy is not available they have nothing to lose by trying. I hope we are not a third world country yet…despite some politicians efforts to make us one and the focus here as far as Im concerned should be to make monoclonal ab therapy available to all who qualify. If convincing evidence comes out for something else that would change the picture obviously but for. now we go with the best we have. Treatment has evolved considerably i. the last year and I suspect 5 years from now will look quite different from what we are doing today.


26 posted on 07/17/2021 9:34:00 PM PDT by Mom MD ( )
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To: SeekAndFind

Apparently, the Lancet got caught lying earlier and quietly retracted their ‘piece’ after it had done it’s job. So now, the Lancet is not much better than CNN or New York Times. They lie.


27 posted on 07/17/2021 9:51:22 PM PDT by ransomnote (IN GOD WE TRUST)
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To: SeekAndFind

I got mine in horse paste. Started I-Mask protocol for outpatient as soon as lost sense of smell while having other hallmark symptoms. But sense of smell lost was my confirmation symptom. Without having a time delay by waiting for a doctor I started it on my own. Felt much better within 24 hrs, and within 48 even moreso.


28 posted on 07/18/2021 12:53:33 AM PDT by inchworm (al )
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To: SeekAndFind
high-dose IVM in 45 COVID-19 hospitalized patients

Not supposed to wait until hospitalized. Supposed to take it as soon as a positive test or symptoms

29 posted on 07/18/2021 6:03:35 AM PDT by Pollard
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To: Mom MD
No differences in clinical evolution at day-7 and day-30 between groups were observed.

IVM has always been strongest as a prophylactic, and you address 'day 7 and day-30', when IVM usually doesn't have a day-7, let alone day-30.

30 posted on 07/18/2021 9:00:59 AM PDT by RideForever
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To: Mom MD

“I agree only large scale trials will settle the ivermectin question and it may be a while til we have those”

No amount of evidence will satisfy you.

https://journals.lww.com/americantherapeutics/Fulltext/2021/06000/Review_of_the_Emerging_Evidence_Demonstrating_the.4.aspx


31 posted on 07/18/2021 9:06:44 AM PDT by Basket_of_Deplorables (Convention Of States is our only hope now! Desantis 2024!!!)
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To: RideForever

that’s day 7 and 30 of recovery not treatment


32 posted on 07/18/2021 9:48:02 AM PDT by Mom MD ( )
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To: Mom MD
that’s day 7 and 30 of recovery not treatment

If you gain Natural Immunity by taking IVM at onset of symptoms and 'surviving', there's little chance of day-7 or day-30. What remains is the comfort of knowing you have natural immunity and no reason to take a 'jab'.

And our grandkids wouldn't be stuck with the bill for our stupidity paying for our pandemic 'vaccine', aka, experimental genetic treatment. Furthermore, previous IVM studies presented on FR have already show IVM is least effective at end stages of the disease. That's the ONE place Remdesivir is useful, and monoclonal therapy with it's exorbitant cost is appropriate.

33 posted on 07/18/2021 10:13:12 AM PDT by RideForever
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To: SeekAndFind

SnF - that is the money quote. (Unless, of course, you were more interested in continuing the propaganda than talking about the truth and saving lives.)


34 posted on 07/18/2021 10:20:36 AM PDT by Triple (Socialism denies people the right to the fruits of their labor, and is as abhorrent as slavery)
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To: RideForever

monoclonal therapy is not useful in end stages of disease. You have it all figured out so carry on. No one will confuse you with facts


35 posted on 07/18/2021 10:41:22 AM PDT by Mom MD ( )
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To: Paladin2
It’s no Silver bullet, but it does seem to be beneficial [and cheap].

That was my take as well.

36 posted on 07/18/2021 11:06:00 AM PDT by ProtectOurFreedom (“Criminal democrats kill babies, folks. Do you think anything else is a problem for them?” ~ joma89)
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To: Mom MD

Thanks. How does one go about finding a doctor and infusion center for MABs in advance of getting sick?

I asked my GP and my immunologist and they both shot me down. They basically said “wait until you get sick and we’ll take care of you then.” That did not give me a warm and fuzzy feeling.


37 posted on 07/18/2021 11:08:50 AM PDT by ProtectOurFreedom (“Criminal democrats kill babies, folks. Do you think anything else is a problem for them?” ~ joma89)
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To: SeekAndFind
The summary above does not discuss dosage needed to achieve the plasma IVM concentrations listed. The paper says...
IVM 6 mg ranurated tablets were used in all cases at a dose of 600 µg/kg/day based on baseline weight rounding to the lower full (6 mg) and half (3 mg) dose. The regimen of 600 µg/kg for 5 days was selected based on the in-vitro data suggesting the need for higher doses than for current indications of IVM, the available data on the safety of this dose in regimens of up to 3 days (either in fast or fed state) and the available information on the PK of IVM, predicting the lack of significant accumulation of IVM after 5 daily doses.
600 µg/kg/day is about triple the dose recommended in other papers.

The Italian RC trial COVidIVERmectin: Ivermectin for Treatment of Covid-19 was going to test ivermectin 600 μg/kg daily for 5 consecutive days + placebo and ivermectin 1200 μg/kg daily at empty stomach with water for 5 consecutive days. Recruitment was terminated because disease incidence has dramatically dropped and there is lack of eligible patients. The study ended June 23, 2021. It isn't clear if the study was completed with the enrolled patients or if it was aborted before completion.

38 posted on 07/18/2021 11:29:41 AM PDT by ProtectOurFreedom (“Criminal democrats kill babies, folks. Do you think anything else is a problem for them?” ~ joma89)
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To: Mom MD

According to UC Health the out-of-pocket cost for infusion fees is between $250-300. The Zelenko protocol, using HCQ + zinc + AZPak is much, much less expensive.

But you’re correct, I presumed monoclonal therapy was given at second stage of CoVID, which you seem to be saying is ineffective at that point. Does this mean you have a treatment that would void the conditions necessary for a EUA for CoVID genetic treatment, aka, ‘the jab’?


39 posted on 07/19/2021 8:38:41 AM PDT by RideForever (Know Islam, No Peace. Know Peace, No Islam.)
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To: RideForever

No. The available treatments and vaccines work hand in hand. None are 100%. Ending the pandemic will take a multifactorial approach including vaccines and treatments. One does not negate the need for the other


40 posted on 07/19/2021 9:01:24 AM PDT by Mom MD ( )
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