Did I read that right? Both arms had 100%?

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Wait, so the control group had no symptoms at all, and the Ivermectin group had minimal symptoms? Weird results.

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what kind of results are these, this results aren't good for ivermectin

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The results are at least partially in. IMO they provide very good evidence that ivermectin provides prophylaxis.

Ivermectin reduced the likelyhood of household members catching covid-19 by 87.3%

Only 7.4% of household members who took ivermectin caught the virus, compared to 58.4% of those in the without-ivermectin households.

Study description: asymptomatic family close contact of confirmed COVID-19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms & diagnosis of COVID-19

Treatment: 2 doses 72 hours apart

The ivermectin group's average age was 40, control group's age 38 (rounding). IVM was 52% male, no IVM was 50.5%.

The results were reported for the primary outcome measure:

Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) [ Time Frame: within 14 days after enrollement ]

history taking and clinical examination

The secondary outcome, development of covid-19 as confirmed by a swab test (loosely paraphrasing) was NOT reported.

The labels in the ClinicalTrials results table are weird -- but these are really the only numbers that look like study results, so here they are (someone on twitter shared his opinion that these are the right numbers):

• In the group of 203 subjects who received ivermectin, 7.4% showed symptoms of covid-19 on day 14.

• In the group of 101 subjects who did NOT receive ivermectin, 58.4% showed symptoms of covid-19 on day 14.

7.4% vs 58.4%. Prophylaxis!

The other reported result is that 5.4% of ivermectin-treated had non-serious adverse events -- side-effects -- mostly in the GI tract. 2 subjects reported mild nervous system disorders: tingling/numbness and sleepiness. There were no side-effects in the control group.

Thoughts:

This appears to be a soundly-designed study, with random assignment to the two treatment groups. The size of the treatment and control groups seems fine, esp. given the huge differential in the result. I wonder why they didn't show p < 0.0001 or whatever it would be.

The dose of ivermectin isn't specified; likely it was 12mg, the standard 200mcg/kg for most adults, but it would be nice to actually know. Possibly they gave 6mg pills to kids?! Dosing 72 hours apart makes sense given ivermectin's 18-hour half-life; the blood level of the drug drops to 12.5% of the original concentration in that time period. It seems to common for ivermectin treatment regimens to apply a second dose after a week. I guess I like 72 hours better (not that my opinion matters).

I would like to see the secondary outcome, which appears to be a PCR test for the virus (it's poorly described). I would also like to see more description of their methodology. Was the original found-positive family member treated with ivermectin? Did those in the control are get placebo or simply nothing? Was the condition of the family members at 14 days determined by an on-site examination? I trust there will be an actual study report eventually with all these details.

The average age is pretty young, 40 for the ivermectin group. The average age for the first birth is 22.7 in Egypt and on average, Egyptian women have four children. Together, these suggest the only threat to validity I can think of: a lot of the subjects young and so may have been covid-19 positive on day 14 and not shown it. Fortunately, that theory is destroyed by the high rate of symptoms in the control group. Control groups rock!

I take as a plus for this study, the fact that 7.4% of those taking ivermectin got sick. We've had a number of 100% cured studies, which makes me suspect that no one was keeping good records, or they're misrepresenting the real results. Call me cynical.

IMO the mind-blowing statistic is the 58.4% who seemed to catch the virus, based on their symptoms. I need to look at those studies of within-household transmission again, but I think that is very high. I wonder if there is something about living conditions where the study was done, that would increase the transmission rate compared to the US or Europe. Irrelevant, though, given the random assignment: we may assume that living conditions were equivalent for the two groups.

1 - (7.4 / 58.4) = .873

So 87.3% less infection with the ivermectin group.

Maybe the impact of ivermectin is more impressive with the raw numbers? 58% of family members caught covid-19 without ivermectin, only 7% with ivermectin.

The following is me thinking as I write, not really arriving anywhere. I suggest you skip it.

Based on not much, the scenario I imagine is:

Waheed (picking a name from the study) gets a positive test at the hospital that's doing the study. They ask him "How many people live with you at home? Do any of them appear to have the virus?" -- the second question because according to the description, only asymptomatic family members get the ivermectin. Waheed says he has 5 healthy family members, so Waheed is handed a package with enough ivermectin to treat 5 people twice. The package includes the instructions to take 1 dose immediately and another 3 days later.

Waheed goes home, and all 5 of his family members take the ivermectin according to the schedule.

14 days after Waheed arrives at home with the meds, someone on the study team does an on-site interview to determine how many of the 5 have covid-19 symptoms. The data thus collected produces the 7.4% result.

Interestingly, the study doesn't say whether Waheed gets ivermectin. Does it matter? It does if you believe that ivermectin clears the virus faster than no treatment, implying Waheed would be shedding virus for a shorter period -- decreasing the probability of making someone else sick. I bet Waheed did get ivermectin.

Why didn't symptomatic family members get ivermectin? To me it seems like they should have, for the sake of their health and also because that would further protect the healthy family members -- but it's not my study.

Were any of the 5 in Waheed's home already sick with covid-19 when they first took the drug? Possibly: they could have been asymptomatic when Waheed was being interviewed after his positive test (or he could have lied). Does that matter? We "know" ivermectin works for people with covid-19. We would expect ivermectin to clear their virus, so they either never show symptoms or the symptoms have cleared by day 14. So never mind.

Given the typically 5-6 lag day between infection and the onset of symptoms, and the typical clearing of the virus after 6 days (for 83.3% of subjects in the Bangladesh trial) -- for those who were symptomatic on day 14, that contributed to the 7.4% who were not protected by ivermectin -- when did they get sick? It seems pretty clear that they probably got sick after taking ivermectin. The 7.4% could have been part of the resistant tail shown by Bangladesh, part of the 16.7% who were not cleared by day 6. Maybe the 7.4% would have been half that on day 16.

All speculation and guesswork. Pay no attention to the man operating the keyboard.

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The results, if born out would be great, but I have some concerns about the methodology and result. That 58 percent number for symptomatic cases sounds insanely high. I think that the overall household transmission rate is 25 percent. Especially given that somewhere around 30-50 percent of regular cases are asymptomatic, this would mean that virtually all close contacts got infected in the control arm. I don't know enough about the reliability of the CBC tests they used to confirm infection.

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More info:

https://clinicaltrials.gov/ProvidedDocs/61/NCT04422561/Prot_SAP_000.pdf

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Can we add a RESULTS flair to articles? It would be nice to just tap the flair to search. Other flairs could be “new trial,” “non-covid research,” etc.

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[deleted]

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Egypt:

Patients PCR-tested positive were randomly assigned to ivermectin or no-ivermectin groups. Those assigned to the IVM group were given enough of the drug for all their household members to have 2 doses.

In two weeks, only 7.4% of ivermectin HMs caught covid vs 58% of non-IVM HMs.

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I noticed that Dr. Marik (in his covid-19 treatment protocol) cites his study in his section for prophylaxis after exposure.

Prophylaxis While there is extremely limited data, the following “cocktail” may have a role in the prevention/ mitigation of COVID-19 disease. This cocktail is inexpensive, safe, and widely available. It should be noted that a recent publication suggests that melatonin my reduce the risk of COVID-19 infection, [1] while many papers suggest that Vitamin D deficiency increases the risk of infection and is associated with a significantly worse outcome. [2-14]

• Melatonin (slow release): Begin with 0.3mg and increase as tolerated to 2 mg at night [1, 15-19]

• Vitamin D3 1000-3000 u/day. Note RDA (Recommended Daily Allowance) is 800-1000 u/day. The safe upper-dose daily limit is likely < 4000 u/day. [2-14, 20]

• Vitamin C 500 mg BID (twice daily) and Quercetin 250 mg daily [10, 11, 21-30] Note that prolonged high dose quercetin has very rarely been associated with hypothyroidism. [31, 32] Quercetin should be used with caution in patients with hypothyroidism and TSH levels should be monitored.

• Zinc 50-75 mg/day (elemental zinc). After 1 month, reduce the dose to 30-50 mg/day. [10, 11, 21, 28, 33-37] • Famotidine 20-40 mg/day [38-41]

• Optional/Experimental: Interferon-α nasal spray for health care workers [42] • Optional: Ivermectin for postexposure prophylaxis (see ClinTrials.gov NCT04422561)

I'm discouraged by the fact that Dr. Marik thinks 4000IU of vitamin D is the upper-limit safe dose. I've been taking 10000IU for a few months.

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