[-] massimaux | 3 points | Oct 10 2020 23:34:53

Abstract

As the world faces COVID-19, the search for effective treatments against the disease and its complications has turned its gaze to drugs that are classically used in other infectious diseases. Some drugs are being examined for the recent evidence on its effects on viral replication and inflammation. The aim of the study was to assess the outcome of Ivermectin-Azithromycin-Cholecalciferol combination therapy on early stages (I-IIa) of COVID-19 patients. This proof of concept study was carried out on confirmed COVID-19 patients in Mexico City, from April 01 to April 20, 2020. Patients who met inclusion criteria were invited to take Ivermectin (6 mg once daily in day 0,1,7 and 8) plus Azithromycin (500 mg once daily for 4 days) plus Cholecalciferol (4000 UI twice daily for 30 days). Treatment outcome was evaluated on the 10th day onward from the first day of the drug intake. Recovery rate of the 28 patients that received the combination therapy was 100%, the mean symptomatic recovery duration was 3.6 days and negative PCR was confirmed on day 10. Imaging findings of patients with pneumonia were improved on day 10. Transient and mild degree of adverse effect like diarrhea and nausea was noted by 3 (10.7%) patients. This study found that the combination treatment might mitigate disease progression without significant adverse effects. Further studies are needed in order to extrapolate these findings to moderate and severe COVID-19.

[-] luisvel | 2 points | Oct 11 2020 00:45:45

Why days 0,1,7,8? Why not 0,2,4,6 for example?

[-] Z3rul | 2 points | Oct 11 2020 19:17:53

this is really well thought trial. really good information

[-] massimaux | 1 points | Oct 11 2020 19:34:46

I agree. Although small sample, the graphs are showing convergence of temperature and saturation towards the normal ranges. On the contrary, many temperature and saturation values in the control group remain out of normal ranges.

[-] massimaux | 1 points | Oct 11 2020 19:46:03

Also, it's important to note that the Ivermectin dosing is double the normal dose used over four days (day 0, 1, 7 and 8). This seems a better solution.

[-] Z3rul | 1 points | Oct 11 2020 19:59:49

dosage changes between parasite or infection. the maximum dosage aproved it's 12mg once daily for 3 days. 6mg daily 4 days it's ok.

Argentina is waiting to get an approved pill of a higher dose for ivermectin to treat covid19. don't know how high yet

and watching this incredible results in moderate dosage makes me think that maybe argentina is going way too hard

[-] massimaux | 1 points | Oct 11 2020 20:09:03

What do you think about this severity dependent dosing, also coming from an Argentina study? Does it make sense?

IDEA protocol includes doses of 24, 36 and 48 mg on days 0 and 7 of treatment equivalent to doses of ca. 300, 450 and 600 g/kg for mild, moderate and severe cases of 80-kg adults, which are lower than the maximum doses already tested in adult humans.

https://www.medrxiv.org/content/10.1101/2020.09.10.20191619v1.full.pdf

[-] Z3rul | 1 points | Oct 11 2020 21:40:43

yes it does, argentina has a very different view of ivermectin, there are many CT already done in argentina about high dosage for humans, before even covid19 started.

https://clinicaltrials.gov/ct2/show/NCT04381884

this was a concept proof study too, the premise was to find the highest safest dose for humans while looking for load viral reduction and behavior.

results were positive with a rapid viral elimination with a 0.6mg/kg dose for 5 days

watch this video if you wanna see the methodology and concepts used in the study. it's a study preview and they point out their knowledge and background in their decision of going hard on the dosage

https://www.youtube.com/watch?v=AAQ1WYjj3Co

[-] massimaux | 1 points | Oct 11 2020 22:29:54

Thank you

[-] luisvel | 1 points | Oct 11 2020 00:51:26

Can’t open it full. Can you?

Here is the full link

https://www.alliedacademies.org/articles/effects-of-ivermectinazithromycincholecalciferol-combined-therapy-on-covid19-infected-patients-a-proof-of-concept-study.pdf

[-] massimaux | 3 points | Oct 11 2020 14:09:35

It opens. Figures 2, 3 and 5 are great sources of information. They compare the intervention vs. control group showing significant improvements in temperature, oxygen saturation (SpO2), oxygenation index (SpO2/FiO2) and plasma ferritin concentration.

[-] lemallette | 1 points | Oct 11 2020 20:10:03

This is not a randomized study, so it really tells us very little, except that the regimen the patients were "invited" to take didn't kill anyone and caused minimal side effects.

As far as study design goes, at this point in time, it would be unethical to NOT give a group of patients the cholecalciferol in the doses mentioned. You must ethically assure good nutrition for all groups. The dose they used is less than half the chronic dose that has ever been reported to cause vitamin D toxicity. The cholecalciferol dose would be reduced to the long term maintenance dose of 4000 IU daily after day 10.

So your randomized controlled study would have four groups, each getting cholecalciferol 4000 IU twice daily:

A. placebo 1, placebo 2.

B. ivermectin, placebo 2.

C. placebo 1, azithromycin.

D. ivermectin, azithromycin.

Seems unlikely that such a study will ever be done, unfortunately.
L. E. Mallette, MD, PhD.

[-] Z3rul | 2 points | Oct 11 2020 21:26:31

this is a ivermectin subreddit why are you pushing a vit d3 agenda?

Don't dismiss neither minimize the positive results.

it did what it was suposed to do: confirm that combined therapy with Ivermectin-Azithromycin-Cholecalciferol given for 7days was effective to reduce symptomatology duration andclinical progression of COVID-19