Replies to post #364711 on Innovation Pharmaceuticals Inc (IPIX)

[MinnieM]

BS. Trial results are UNKNOWN for the Brilacidin ph2 Covid trial.

https://clinicaltrials.gov/ct2/show/NCT04784897

This Phase 2 study is a randomized, blinded, placebo-controlled, parallel group design.

The target population to be treated are patients with moderate to severe COVID-19, SARS-CoV-2 infection confirmed by positive standard polymerase chain reaction (PCR) test (or equivalent/ other approved diagnostic test) within 4 days prior to starting study treatment, and hospitalized with respiratory distress but not yet requiring high-level respiratory support (as defined in exclusion criterion #2). See inclusion/exclusion criteria.

The study is comprised of three parts:

Screening/ Baseline visit (Day -1 to 1): Lasts up to 24-48 hours and comprises screening/ baseline assessments. This visit will confirm that study inclusion and exclusion criteria are met by participants prior to randomization.
Treatment period (Day 1-3 with potential to expand to Day 4-5): Randomized subjects will receive blinded study treatment once daily for 3 days by IV infusion, in addition to SoC.
Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status.

All subjects will undergo a series of efficacy and safety assessments, including laboratory assays. Additional blood samples and nasopharyngeal (NP) swabs will also be obtained (oropharyngeal (OP) swabs to be collected only in exceptional circumstances).

The study started with 3 days of study drug administration. After an interim analysis safety review, by an independent Data Monitoring Committee (DMC), dosing has since been extended to 5 days.

If there was only one trial site it might have been possible for those interacting with patients to gain a sense of how the trial was going. However, there are only 120 participants spread out over multiple locations. No location has enough participants to gain any sense of how the trial is going.

Locations

United States, Illinois

IPI Investigator Site Winfield, Illinois, United States, 60190
United States, Ohio
IPI Investigator Site Toledo, Ohio, United States, 43608

Russian Federation

IPI Investigator Site Barnaul, Russian Federation, 656045
IPI Investigator Site Moscow, Russian Federation, 111398
IPI Investigator Site Moscow, Russian Federation, 119048
IPI Investigator Site Moscow, Russian Federation, 121359
IPI Investigator Site Moscow, Russian Federation, 125367
IPI Investigator Site Nizniy Novgorod, Russian Federation, 603155
IPI Investigator Site Pushkin, Russian Federation, 196600
IPI Investigator Site Saint Petersburg, Russian Federation, 198205
IPI Investigator Site Saint Petersburg, Russian Federation, 198510
IPI Investigator Site Saint Petersburg, Russian Federation, 199106

I'm hoping for a positive trial outcome in this Covid trial. It's needed greatly for both society and shareholders. When relatives ask me what to expect I simply say I don't know. We'll have to wait for results released in August, September or possibly October. Declaring trial failure at this point is BS.








Message in reply to: Bolded
good grief. As the world burns I would be happy with former statement saying 15 or 30 days no adverse effects. But we never got that did we?

Because we are not gonna get it

Since it failed

[Lemoncat]

Data can't be unblinded until at least July 27 which is 50 days beyond full enrollment.

You disagreeing with the trial protocol doesn't mean the drug failed.

Go IPIX!