A randomized double-blind placebo-controlled trial of oral ivermectin outpatient treatment, to prevent hospitalisation, of those at high risk for hospitalization due to SARS-CoV-2 (COVID-19) (Australia 2020-10-07) New trial!

[-] Z3rul | 2 points | Oct 08 2020 03:23:06

again 200mcg it's a very low dose if they wanna treat an advanced state of infection

[-] Haitchpeasauce | 1 points | Oct 08 2020 04:00:20

Good first step though, first in vivo study in Australia, and RCT at that. Hopefully this opens up conversation about combination therapy and dosage.

[-] Z3rul | 2 points | Oct 08 2020 06:14:04

you are a little late to the party.

[-] Haitchpeasauce | 1 points | Oct 08 2020 06:30:40

Don't get me started.

[-] TrumpLyftAlles | 1 points | Oct 08 2020 01:31:00

This is a really solid design! Shouldn't take too long. Does Australia have enough new cases?

N=400, randomly assigned to treatment and placebo

1 dose of ivermectin at 200mcg with a possible second dose if subjects report that their condition definitely hasn't improved.

Primary outcome:

• The difference between the proportions of participants progressing to hospitalisation due to SARS-CoV-2 or death (for any reason), if it occurs without hospitalisation, on or before Day 14, in the two arms (ivermectin versus placebo)
• For primary and secondary endpoint definitions, hospitalisation is defined as hospitalisation for at least 24 hours duration, or death should it occur within that 24 hours. Hospitalisation does not include hospital in the home and Day 1 is day of 1st treatment

Timeframe: 14 days

Uniquely looking at older patients

Inclusion criteria:

• People aged 50 years and over who have tested positive for SARS-CoV-2 (by any NAAT/PCR based testing system recognised by public health authorities) within the preceding 12 days

[-] Haitchpeasauce | 3 points | Oct 08 2020 02:05:26

The inclusion/exclusion criteria are a bit puzzling.

Does Victoria (the study is specifically targeting this state) have enough new cases of people:

Over 50 years
With symptoms that are not getting better after 10 days
Diagnosed with COVID-19 within the past 12 days
Have any of the following risk factors
blood glucose control medication
high blood pressure medication
heart disease medication but NOT warfarin
lung disease medication (oral or inhaled)
currently smoke
target sample size of 400

I am not sure. New case numbers are dropping rapidly at the moment as well.

The investigation looks like it is very specifically testing late intervention in nursing home cases with comorbidities; the primary investigator from the Department of Diabetes and Endocrinology at Royal Melbourne Hospital. Case severity is not specified, but the primary/secondary outcomes are hospitalisation and death, so presumably they will not have progressed into severe cases upon inclusion. I hope for a statistically significant improvement but case mortality will probably still be high given the type of people being treated and lateness of intervention.