TrumpLyftAlles | 4 points
Preliminary Ivermectin study covid-19 (Argentina 2020-07-26)https://www.youtube.com/watch?time_continue=13&v=OUrwuQn2hic&feature=emb_logo
[-] TrumpLyftAlles | 3 points
It took two tweets:
Thanks a lot @themanof68! Good study! I wrote it up here:
https://reddit.com/r/ivermectin/comments/iafa9q/preliminary_ivermectin_study_covid19_argentina/?
Among hospitalized patients, the 32 in the #ivermectin-treated group had a 3% fatality rate, compared to 21% among the 14 who did NOT receive ivermectin.
The former spent 1/3 less time in hospital.
In the Baghdad study, ivermectin reduced LOS 42%.
https://www.medrxiv.org/content/10.1101/2020.07.07.20145979v1
[-] foggynotion | 1 points
Great to see in a study like this such high doses were safely tolerated. ~~These doses would be about 8-12X the US FDA guidelines for parasitic infection of 3mg (or 200mcg/kg).~~ I would be very curious if they were giving them 24-36mg with high fat food, which would increase the bioavailability of the ivermectin another 2.5 times. It would make the doses in this study in the range of 20-30X the currently used amount of 200mcg/kg
[-] TrumpLyftAlles | 1 points
These doses would be about 8-12X the US FDA guidelines for parasitic infection of 3mg (or 200mcg/kg).
That's not right.
The maximum dose on the protocol is 48mg. For a 150 pound person, that's 705mcg/kg -- 3.5 times the FDA's 200mcg/kg. There's a trial dosing at 1200mcg/kg.
The 200mcg/kg implies 13mg of ivermectin for a 150 pounder-er.
This site is my go-to for dosing calculation.
I would be very curious if they were giving them 24-36mg with high fat food, which would increase the bioavailability of the ivermectin another 2.5 times.
Interesting point. Dr. Aguirre's protocol specifies for critical patients: 18mg every 8 hours after meals.
Reminds me: I haven't eaten today!
[-] foggynotion | 2 points
ah gotcha!
[-] TrumpLyftAlles | 1 points
:)
[-] TrumpLyftAlles | 3 points | Aug 15 2020 21:27:14
This is a brief (2:19 minute) youtube video presenting the results of MDs treating patients with ivermectin in Argentina, which was posted to youtube on 2020-07-26. The presenter is Dr. Eduardo Carvallo from the University of Buenos Aires, Argentina. It was presented on 2020-07-17.
Thanks for Ahmed Afifi @themanof68 (on twitter) for the link to this video!
Main reults:
NONE of the 135 patients with mild covid-19, who were treated as outpatients, got worse after receiving 24mg of ivermectin, followed by the same dose a week later. Statistically, 7 should have progressed to the point that they needed hospitalization. None did.
Among 32 moderate-to-severe patients who were treated with ivermectin+dexamethasone, only 1 died, while 3 died among 14 similarly-ill patients who did not receive ivermectin, a result that is statistically significant at the p=.04 level. Length of stay was shorter with ivermectin, 14 days vs 21 days.
In brief:
135 covid-19 positive outpatients received 2 doses of ivermectin a week apart. NONE advanced to requiring hospitalization.
Among hospitalized patients, the 32 in the ivermectin-treated group had a 3% fatality rate, compared to 21% of the 14 who did NOT receive ivermectin. The former spent one-third less time in the hospital.
Here are my notes from watching the vido. I left in the Spanish from the slides, so someone can (please!) correct me if the translation is wrong.
Most of the text is from the English subtitles, indicated by being quoted
like this
Double-quotes
like this
are used when I'm quoting something other than the video, e.g. an FDA factoid.
A couple times I edited the text a little, for clarity. The gist is accurate to the best of my ability.
ARGH: This post exceeds reddit's 10,000 limit, so I'll put the notes from the video into a reply.
Edit: As foggynotion points out, an important feature of this study might be the BIG DOSES. The 48mg dose for patients requiring ventilation is about 700mcg/kg for someone weighing 150 pounds.
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[-] TrumpLyftAlles | 2 points | Aug 15 2020 21:27:31
My notes from the video:
We call this protcol I.D.E.A. because it employs Ivermectin, Dexamethasone, Enoxaparin and Aspirin.
Dexamethasone is kind-of FDA approved. From this July 14 FDA update:
Today, the FDA added dexamethasone sodium phosphate to the lists of drugs for temporary compounding by outsourcing facilities and pharmacy compounders during the COVID-19 public health emergency. These updates help address shortages and access concerns affecting some drugs urgently needed for hospitalized COVID-19 patients.
The FDA's action was probably prompted by this trial reported in Nature on June 23:
Coronavirus breakthrough: dexamethasone is first drug shown to save lives
How many researchers believe that dexamethasone may be helpful with covid-19?
There are 24 trials registered at ClinicalTrials.gove looking dexamethasone vs covid-19.
One of those trials is looking at ivermectin + dexamethasone.
Enoxaparin is an anticoagulant that helps prevent the formation of blood clots. Enoxaparin is used to treat or prevent a type of blood clot called deep vein thrombosis (DVT), which can lead to blood clots in the lungs (pulmonary embolism).
There are 34 trials on ClinicalTrials.gov testing enoxaparin against covid-19.
Aspirin was probably included because it can prevent blood clots. From the FDA:
It [aspirin] can help prevent a heart attack or clot-related stroke by interfering with how the blood clots.
13 ClinicalTrials.gov covid-19 trials include aspirin.
We may conclude that the I.D.E.A. protocol is applying drugs that a lot of scientists believe may be helpful against the virus. It's a solid, reasonable protocol.
Like the protocol of Peru's Dr. Aquirre, I.D.E.A. inceases the dose of ivermectin as the severity of covid-19 disease increases. The following is the I.D.E.A protocol, taken from a slide shown 10 seconds into the video:
For "Firm Suspicious Case or Confirmed Case", I.D.E.A. recommends "24 mg orally at a does of 200 mcg/kg in a single dose, to be repeated a week later." Patients at this stage also receive 250mg aspirin.
For "Moderate at clinical stage" the dose is 36mg at a dose of 450 mgc/kg in a single dose, to be repeated a week later." Patients also receive 4mg of dexamethasone at this stage, in addition to 250mg aspirin, and "Low Flow Oxygen or Oxygen Concentrator".
For "Severe case with bilateral pneumonia" the ivermectin dose is "48 mg via gastric cannulae, at a dose of 600 mgc/kg to be repeated a week later", plus the 4mg dexamethasone. Apirins is replaced by enoxaparin, implying that the protocol authors want a more heavy-duty anti-blood clotting drug. Patients are placed on mechanical ventilation.
Dr. Aguirre uses dexamethasone and enoxaparin to moderate-to-worse cases; I.D.E.A. only gives enoxaparin for the worst cases.
When the mildest-stage patients come in, they take his pharyngeal sample and administer the 24mg of ivermectin.
The sample is for determining whether the patient has covid-19.
200mcg/kg implies a 24mg dose if the patient weighs at least 265 pounds (120 kg). They were dosing most/all their patients at higher than 200mcg/kg.
Note that they do not wait for comfirmation from the test before giving the patient ivermectin. It's super-safe (and cheap) and is thought to clear the virus, so why wait? Very possibly, some of the patients who tested negative for covid-19 did not subsequently catch the virus, because ivermectin provide prophylaxis (this is unproven, thus far).
After 72 hours, test results are in and they notify the suspect if the swab was negative or positive.
But, of course, there are patients who arrive directly in moderate or severe conditions. In those cases, the dose if ivermectin we give is 36mg. We also give 4mg of dexamethasone and give him low-flow oxygen.
The protocol says moderate patients get 36mg, severe get 48mg.
Slide:
* En el periodo de aplicacion del protocolo I.D.E.A., se asistieron 135 pacientes + con formas leves.
* Se administro la medicacion segun tabla.
* Se indicaron pautas de alarma.
* Se mantuvo el contacto con esos pacientes, apra controlar evolucion.
* NINGUNO de ellos evoluciono a formas mas severas, que requirieran internacion, en los 21 dias ulteriores al inicio de la medicacion.
(Apologies to Spanish speakers, the above was manually typed from the slide, and I don't know how to do the diacritical marks over some of the o's and a.)
In English:
* In the period of application of the I.D.E.A. protocol, 135 patients with mild covid-19 disease were treated.
* Medication is given according to the protocol.
* Severity guidelines were indicated [where did they fit on the protocol]
* Contact with these patients was maintained to control evolution [advancement of the disease]
* NONE of them evolved to more severe forms, requiring hospitalization, within 21 days after the start of medication.
Cure! None of the 135+ patients with mild covid-19 symptoms, tested positive for covid-19 advanced to a more severe state of disease.
We can say that, in the study period that ended a few days ago, we found 135 mildly positive patients, i.e. covid-positive patients, that could be managed on an outpatient basis. We gave the medication according to the above [protocol] guidelines. We've had 0 mild patient admissions. NONE of the mild patients evolved to moderate. We should expect 5%, at least 7 patients. We had zero patients.
From the table shown around 1:30:
The 32 patients in the I.D.E.A.-treated group were 13% female and 23% male, compared to 67% female and 33% male in the 14-patient "other treatment" (control) group. That difference is statistically significant, p=.025.
Interpreting "perdida de seguimiento (derivacion)" (It was hard to see, I may have typed that wrong) as "lost of follow-up", 2 cases dropped out of the I.D.E.A. group and 1 from the other (not significant).
At 1:32, a slide is shown with two tables and a bar chart comparing the two groups on 4 criteria. I couldn't read the bar chart labels.
Table at top-left:
| Outcome| With I.D.E.A. | With other treatments | p-value |--------|------------|--------|--------| | Lived | 31 (96.9%) | 11 (78.6%) | 0.04 | | Died | 1 (3.1%) | 3 (21.4%) | | | Total | 32 (100%) | 14 (100%) | |
Table at right, rounded to 3 digits:
|Label| Value|
|-------| -------|
|RA I.D.E.A.| 0.0315 |
|Without I.D.E.A | 0.234 |
|RR|0.146 | |RAR |0.183 | |RRR |85.5 | |NNT |5.46 |
Can someone help me interpret these numbers? The top to are the percent who died. RR = Risk Ratio? 15% more likely to die without ivermectin? What are the others?
Finally, our conclusions:
TLATODO: Insert image (right now imgur is broken)
Those in blue are treated with I.D.E.A, and in orange are patients treated with another protocol.
With I.D.E.A protocol the patients had a faster medical discharge, in 14 days with I.D.E.A. vs 21 days with the other group.
Shorter length of stay was also shown in the Baghdad study, in which the with-ivermectin length of stay was only 57% as long as the without-ivermectin length-of-stay: (7.62 days ±2.75 versus 13.22 ±.90 days, p=0.00005).
And now the most important thing. Despite having a small "n". We had one death with I.D.E.A. and 3 deaths in the other group.
Slide:
De 32 pacientes moderados/severos, estadisticamente la mortalidad es del 25%. Con ivermectina + dexa, solo murio el 3.1%
De 135 pacientes LEVES, estadisticamente se agrava al menos el 5% de los infectados. Con ivermectina, NINGUNO se agravo.
In English (edited a little):
Of 32 moderate / severe patients, the expected mortality is 25%. With ivermectin + dexa, only 3.1% died
Of 135 mild patients, we would expect at least 5% of those infected would progress to more serious disease. With ivermectin, NONE got worse.
We can say that, out of a total of 32 moderate or severe patients, statistics say there is a 25% mortality rate. In our case it was 3%.
Out of a total of 135 MILD patients, we can say that the worldwide statistic is that 5% would end up in the hospital. Which would be 7 patients. In our case, it was 0.
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[-] Z3rul | 1 points | Aug 16 2020 03:47:04
Riesgo Atribuible (RA) = Risk Score
Riesgo relativo (RR) = Relative Risk
Reducción absoluta del riesgo (RAR) = Absolute risk reduction
Reducción del riesgo relativo (RRR) = Relative risk reduction
Número necesario a tratar (NNT) = Number needed to treat
ABSTRACT
Although most scientific works usually analyze their data in terms of statistical significance, it is less frequent to find information about its clinical relevance. Calculating relative risks, relative risk reduction, absolute risk reduction and number needed to treat may help us to determine the clinical significance of the study results. Absolute risk reduction (risk difference between intervention and control branches) and its inverse value, number needed to treat, are the most useful figures to quantify the effort that will have to be made to achieve one more event of the desired effect.
--
these are offset numbers that gives you an idea of how big the effort needs to be to get a desire result in a bigger study and how low risk is.
basically this study has a really good low numbers and a amazing low risks % (85.5)
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[-] TrumpLyftAlles | 3 points | Aug 16 2020 04:29:52
Thanks so much for your reply!
Now I just have to grapple with what these terms really mean. I studied statistics in college. That was more than 4 decades ago. I don't know if these measures were around then. If they were, I missed them in my education, or forgot them.
Clinical relevance SHOULD be the criterion. p < .05 is all very well. I always want to know what the practical implications are, not whether something is statistically significant.
Thanks again!
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