Trial Profile
A Phase IIb/III, multi-center, randomized, placebo-controlled trial of remestemcel-L for the treatment of patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19)
Status:
Recruiting
Phase of Trial:
Phase II/III
Latest Information Update: 03 Dec 2020
Price :
$35
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At a glance
- Drugs Remestemcel-L (Primary) ; Antivirals; Dexamethasone; Immunomodulators
- Indications Adult respiratory distress syndrome
- Focus Therapeutic Use
- Sponsors Mesoblast
- 19 Dec 2020 According to a Novartis media release, this study is anticipated to be completed in early 2021.
- 18 Dec 2020 According to a Mesoblast media release, During the course of the trial, as the pandemic has evolved, numerous changes in the treatment regimens for COVID-19 patients occurred, including both prior to and while on mechanical ventilation that may have an effect on the mortality endpoint in the trial. These include extended management of patients prior to ventilator support, and use of experimental therapies such as dexamethasone, anti-virals, and re-purposed immunomodulatory agents.
- 18 Dec 2020 According to a Mesoblast media release, The DSMB reported that there were no safety concerns and noted that the trial is not likely to meet the 30-day mortality reduction endpoint at the planned 300 patient enrolment. The DSMB recommended that the trial complete with the currently enrolled 223 patients, and that all be followed-up as planned.