I would also add that the trial was funded by the NIH to ascertain the effectiveness of Remestemcel-L in the treatment of COVID-19 ARDS during a global pandemic.... This is important for people to remember as ARDS in general at this time is not their purview.......Yes BUT I would put the last piece slightly differently
This is important for people to remember as ARDS is doubly in their purview at this time. While it is true pandemic influenza is at all time lows at the moment (at least in Australia because of how we have fought COVID-19), both COVID-19 and Pandemic Influenza currently kill most people via ARDS.
To expand, but not too much
- Both these diseases are within both the FDA and NIH remit as partners in the PHEMCE, with pandemic influenza mentioned specifically and COVID-19 covered by the
Determination that a Public Health Emergency Exists for 2019 Novel Coronavirus (2019-nCoV) on 31 January 2020.
I have expanded the first used acronyms for emphasis, from the page
About the PHEMCE;
"The
Public
Health
Emergency
Medical
Countermeasures
Enterprise’s mission is to advance national preparedness for
Chemical
Biological
Radiological
Nuclear and
Emerging
Infectious
Disease threats, including pandemic influenza, by coordinating medical countermeasure-related efforts within
Health
Human
Services and in cooperation with PHEMCE partners."
And also;
"The PHEMCE is led by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three primary HHS internal agency partners: the Centers for Disease Control and Prevention, the Food and Drug Administration and the National Institutes of Health"
Two of the 3 primary partners have had direct input into COVID-19 / ARDS trial. The NIH funding the entire trial and also being responsible for either the initial creation of or ongoing funding of the
National Heart, Lung, and Blood Institute (NHLBI) and the
Cardiothoracic Surgical Trials Network (doing the onground work and organisation, and possibly providing the DSMB for which they have protcols in place), generally I would say the NIH have marshalled rather a lot resources toward the trial.
As of the 4 November update to ClinicalTrials.gov the NHLBI are now recognised as Collaborators in the trial;
The FDA had fairly direct input into the design of the trial, also providing for potential early termination of the trial if predetermined Bayesian thresholds are reached.
And finally, if you have followed the link to the
National Heart, Lung, and Blood Institute (NHLBI) you will have noticed the very first point of interest on the current page which is
why I think is why Mesoblast initially thought COVID-19 was worth persuing - COPD. Way back in time, 3 March 2020, or 29 September 2016 for the paper, or rather more years back to the trials.
https://hotcopper.com.au/posts/43279966/singleThe NIH, and NHLBI, do seem to have an interest in ARDS generally. The NIH came to the party very swiftly after the initial Icahn 12 patient study with funding and resources as did the FDA with trial design parameters. It was only very shortly after the trial was designed that the FDA released their initail guidance to parties wanting to design and run trials related to COVID-19. The therpeutics portion of the guidance reflects some of the design used quite closely.
(20min delay)