Real-World Effectiveness of hydroxychloroquine, azithromycin, and ivermectin among hospitalized COVID-19 patients: Results of a target trial emulation using observational data from a nationwide Healthcare System in Peru

[-] No_Entertainment_764 | 3 points | Oct 08 2020 14:40:57

it seems it was a small, single-dose of ivermectin for those already hospitalised.

[-] massimaux | 3 points | Oct 08 2020 15:09:30

Yes, they state the following:

The treatment groups were defined as follows: hydroxychloroquine/chloroquine alone (HCQ group), ivermectin alone (IVM group), azithromycin alone (AZIT group), hydroxychloroquine/chloroquine plus azithromycin (HCQ + AZIT group), and ivermectin plus azithromycin (IVM + AZIT group) at doses recommended by the Peruvian Ministry of Health (10, 11).

And the ministry of health recommends the following dosing for Ivermectin:

15 - 25Kg -- 3 mg

25 - 45Kg -- 6 mg

45 - 65Kg -- 9 mg

=65Kg -- 12 mg

To compare:

The Florida ICON study used 200mcg per kg body mass but not limited to 12 mg (as far as I understood).
The ICON study allowed for a second dose after 7 days if there was no improvements.

Hopefully, the outpatient Ivermectin protocol (treatment within first 5 days of symptoms) is not beaten by studies like this one today.

[-] fyodor32768 | 2 points | Oct 08 2020 12:42:25

It's an observational trial with all the issues that come with that, but the results found no benefit to Ivermectin.

[-] Ok-Film-9049 | 1 points | Oct 08 2020 13:39:39

Darn. I really thought it definitely helped at the end stage via blocking micro thrombi accumulation and as an anti inflammatory.

[-] luisvel | 2 points | Oct 08 2020 13:39:52

Waiting for reviews.

[-] Z3rul | 2 points | Oct 09 2020 02:07:40

this is really vague, and the ivermectin arm is simulated data. not real evidence

[-] massimaux | 1 points | Oct 09 2020 09:08:32

What do you mean by simulated data?

[-] No_Entertainment_764 | 2 points | Oct 14 2020 00:40:21

I guess this is a direct outcome of this study: https://www.en24.news/2020/10/peru-coronavirus-peru-minsa-withdraws-azithromycin-ivermectin-and-hydroxic.html

[-] TrumpLyftAlles | 1 points | Oct 30 2020 22:31:34

Bad decision based on a terrible, terrible study. :(

[-] movethroughit | 2 points | Oct 20 2020 22:11:10

"We allowed a grace period of 48 hours to initiate therapy to assess a more realistic clinical question: what is the effectiveness of initiating therapy compared to only receiving standard care within 48 hours of hospitalization? Hence, patients who received any of the treatment regimens after 48 hours of hospitalization were assigned to the control group, similar to an intention-to-treat analysis."

WTF?

[-] TrumpLyftAlles | 1 points | Oct 30 2020 22:27:39

WTF?

Indeed! I finally read the PDF and came across that bit. Here's a longer excerpt:

We conducted a retrospective cohort analyzing data obtained from electronic records of patients hospitalized with COVID-19 in mid- and high-level complexity hospitals from the Peruvian Social Security Health System (EsSalud). We emulated a target trial to obtain robust estimates of clinical effectiveness for hydroxychloroquine/chloroquine, azithromycin, ivermectin, alone or combined, on relevant clinical outcomes (12, 15).

We allowed a grace period of 48 hours to initiate therapy to assess a more realistic clinical question: what is the effectiveness of initiating therapy compared to only receiving standard care within 48 hours of hospitalization? Hence, patients who received any of the treatment regimens after 48 hours of hospitalization were assigned to the control group, similar to an intention-to-treat analysis. As mentioned before, we only excluded patients who developed any of the outcomes within 24 hours of admission; therefore, some included patients could have developed an outcome before being assigned to any group due to the grace period (48 hours). Given that these patients could have potentially been assigned to any group, they were randomly distributed between the control and treatment groups to avoid time-dependent bias due to inappropriate exclusion or treatment assignment (12).

Do you understand the theory they're putting forward? I don't. Especially the part I highlighted. If you wanted to do a study that fails to show any significant effects, the highlighted bit seems like the strategy to accomplish that.

[-] movethroughit | 2 points | Oct 30 2020 23:28:33

"If you wanted to do a study that fails to show any significant effects, the highlighted bit seems like the strategy to accomplish that."

I'm going to have to read that a few times, but that's exactly what I was thinking. Assigning any patients that got any of the treatments (within 48 hours of hospitalization) over to the control group seems like an especially glaring error, depending on how many were so assigned.

[-] TrumpLyftAlles | 2 points | Oct 30 2020 23:48:24

depending on how many were so assigned.

And they were totally opaque about how many that was, right? I got so mad at the study that my usual skim ended abruptly when I read that.

If you don't know if a patient belongs in the experimental or control group, leave the patient out of the friggin' study, I always say. ;)

[-] TrumpLyftAlles | 1 points | Oct 30 2020 22:30:24

Move, would you be willing to please post this to /r/covid19 so they will trash the study? Include in your post the bits from the PDF that I posted? I'm banned there for a while for the sin of posting about my personal vitamin D regimen (I don't know why that sub is so adamant about that).

[-] movethroughit | 2 points | Oct 30 2020 23:34:16

Will do.

[-] TrumpLyftAlles | 1 points | Oct 30 2020 23:44:54

Great, thanks! :)

[-] movethroughit | 1 points | Oct 31 2020 03:02:54

Looks like it was already posted:

https://old.reddit.com/r/COVID19/comments/j7bork/realworld_effectiveness_of_hydroxychloroquine/

[-] TrumpLyftAlles | 1 points | Oct 31 2020 03:18:18

Thanks for trying. I'm disappointed that the design didn't get suitably trashed. Someone actually posted the problematic paragraph but the reply wasn't responsive, and no one said WTF. Bummer.