This is interesting. In addition to the two huge multi center phase III trials of Remdesivir for Covid 19 with estimated completion some time in May 2020, there is a smaller but very large trial in Beijing with estimated completion May 1 2020. The East is Remd ! May Day May Day May Day
“Estimated Study Completion Date : May 1, 2020”
Finally there is a very large trial in Hubei province with estimation completion date April 27 2020
“Estimated Study Completion Date : April 27, 2020”
Also there is expanded access already. This is instead of individual requests or compassionate use. Note that one exclusion criterion is eligibility for a controlled trial — people will have to risk getting placebo, because they are eligible for a trial.
I think this is ethical. You read it here.
On the other hand, they only have enough Remdesivir for 30,000 patients
we have proactively and rapidly scaled our supply chain. As of late March, using the active ingredient we already had in our inventory, we have increased our supply to more than 30,000 patient courses of remdesivir on hand, assuming a 10-day course of treatment for patients.
The synthesis takes time and requires reagents which are in short supply, so they can’t scale up immediately
Our goal is to produce a total of:
More than 140,000 treatment courses by the end of May 2020
More than 500,000 treatment courses by October 2020
More than 1 million treatment courses by December 2020
Several million treatment courses in 2021, if required
Capacity Expansion through External Manufacturing
We have supplemented our internal manufacturing with significant additional capacity from multiple manufacturing partners in North America, Europe and Asia. Through these efforts, we believe we have created a manufacturing network capable of producing large volumes of remdesivir at the fastest pace feasible.
I think this is a case for some Defence Production Act_ion.
Update: it seems the 1.5 million doses for over 140,000 patients are available already. Gilead seems to have under promised and over delivered. https://www.statnews.com/pharmalot/2020/04/05/gilead-covid19-coronavirus-remdesivir/
Update2: more evidence that Remdesivir works . This is a leak of preliminary data from one of the phase III trials.
“Remdesivir was a miracle” — Slawomir Michalak Covid 19 Survivor
I told you “possibly so”. Actually checking I see that I did not predict teh expanded access program. I guessed individual requests for compassionate use. So I was wrong about what would be done. I should applaud the FDA for being more flexible than I guessed they would be
Gilead has partnered with contract manufacturers for most of its anti-viral treatments so they are gearing up as fast as they can. And the production of this treatment requires careful quality control. I’m not sure going DPA is going to help that much especially since the order comes from the dumbest person on the planet (Trump). I shudder to think how his band of court jesters could screw this all up if they tried to help.
Texas Right to Know Calls on US to Consider COVID-19 Ozone Therapy After It Shows Promise in Italy
“Professor Marianno Franzini stated, … From preliminary reports from autopsies of those who died from COVID-19, it appears that the virus immediately attacks the microcirculation system causing widespread thrombosis. Several hospitals are using Major AutoHemo Therapy (MAHT), a protocol that extracts the patient’s blood, bubbles oxygen ozone through the blood in a saline or heparin bag, and is infused back into the patient. Patients showed clinical improvement in 1-2 days of receiving one infusion, one time a day. The earlier you treat the person the better the results you have.”
* * * * * *
What is ozone therapy? Benefits and risks (2018)