April 24, 2020 06:00 ET | Source: Mesoblast Limited
Key points:
83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated with two infusions of Mesoblastâs allogeneic cell therapy remestemcel-L within the first five days under emergency compassionate use at New York Cityâs Mt Sinai hospital during the period March-April 2020
75% (9/12) have successfully come off ventilator support within a median of 10 days
These results contrast with only 9% of ventilator-dependent COVID-19 patients being able to come off ventilators with standard of care treatment and only 12% survival in ventilator-dependent COVID-19 patients at two major referral hospital networks in New York during the same time period1,2
This compassionate use treatment experience has informed the design of the clinical protocol for the randomized, placebo-controlled Phase 2/3 trial of remestemcel-L in ventilator-dependent COVID-19 moderate/severe ARDS patients across North America
NEW YORK, April 24, 2020 (GLOBE NEWSWIRE) — Mesoblast Limited today announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblastâs allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York Cityâs Mt Sinai hospital.
In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.1 Moreover, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients at a second major referral hospital network in New York City during the same period.2 These poor outcomes are consistent with earlier published data from China where mortality rates of over 80% were reported in patients with COVID-19 and moderate/severe ARDS.3
Mesoblast Chief Executive Dr Silviu Itescu stated: âThe remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients.â
When Dr. Ioannidis released his Santa Clara serology survey he was talking about a factor of "50 to 85" times the officially confirmed coronavirus number. In Miami the factor is only 16, which is kind of interesting. It would be great to get a lot more serology surveys done, but things do point towards the case fatality rate being between 16 to 85 times lower than the first assumptions. Edit: another serology survey in LA county puts the factor at 40. This is actually great news.
So, yes, it looks like a managed, cautious approach to exiting lock-down is now the right strategy. It will be interesting how it goes here in Germany as (some) kids return to school and some shops open. Same holds true for a lot of other European countries.
If anyone has a lot of time on their hands or suffers from incurable insomnia, this is worth watching (warning: it's over an hour long).
thanks, i'll put that video in my cue
yes we need more testing and good data (i saw a chart where florida is exceptionally lower in several key categories compared to other states)
probably several factors at work here to explain that
please check out the swede video below too (interesting take and the more data i see helps me understand what he has said and why he said it)
climbing down the ladder one rung at a time seems rational
there's no way around the fact that as we come out of our shelter worldwide (and with more testing) we will see a spike in positive cases
managing that as best we can with good data is key
About 6 percent of Miami-Dade’s population — about 165,000 residents — have antibodies indicating a past infection by the novel coronavirus, dwarfing the state health department’s tally of about 10,600 cases, according to preliminary study results announced by University of Miami researchers Friday.
The study, spurred by Miami-Dade County officials, will be an ongoing weekly survey based on antibody testing — randomly selecting county residents to volunteer pinpricks of their blood to be screened for signs of a past COVID-19 infection, whether they had tested positive for the virus in the past or not. The goal is to measure the extent of infection in the community.
Friday’s results, based on two weeks of countywide antibody testing and about 1,400 participants, found that about half of the people who tested positive for antibodies reported no symptoms in the 14-17 days before being tested. If the trend holds, the findings could have major implications for understanding not only the number of people infected, but also how many have symptoms and, in turn, how the virus spreads.
Erin Kobetz, a University of Miami professor of medicine and public health sciences and the lead researcher on the project, presented the findings along with Miami-Dade Mayor Carlos Gimenez during a press conference on Friday.
When Dr. Ioannidis released his Santa Clara serology survey he was talking about a factor of "50 to 85" times the officially confirmed coronavirus number. In Miami the factor is only 16, which is kind of interesting. It would be great to get a lot more serology surveys done, but things do point towards the case fatality rate being between 16 to 85 times lower than the first assumptions. Edit: another serology survey in LA county puts the factor at 40. This is actually great news.
So, yes, it looks like a managed, cautious approach to exiting lock-down is now the right strategy. It will be interesting how it goes here in Germany as (some) kids return to school and some shops open. Same holds true for a lot of other European countries.
If anyone has a lot of time on their hands or suffers from incurable insomnia, this is worth watching (warning: it's over an hour long).
International law experts told Reuters that efforts in U.S. courts to hold China liable for the virus would probably fail.
A legal doctrine called sovereign immunity offers foreign governments broad protection from being sued in U.S. courts, said Tom Ginsburg, a professor of international law at the University of Chicago.
Ginsburg said he thought the recent flurry of lawsuits against China serves a political end for Republican leaders facing an election in November.
âWe are seeing a lot of people on the political right focus on the China issue to cover up for the U.S. governmentâs own errors,â Ginsburg said.
About 6 percent of Miami-Dadeâs population â about 165,000 residents â have antibodies indicating a past infection by the novel coronavirus, dwarfing the state health departmentâs tally of about 10,600 cases, according to preliminary study results announced by University of Miami researchers Friday.
The study, spurred by Miami-Dade County officials, will be an ongoing weekly survey based on antibody testing â randomly selecting county residents to volunteer pinpricks of their blood to be screened for signs of a past COVID-19 infection, whether they had tested positive for the virus in the past or not. The goal is to measure the extent of infection in the community.
Fridayâs results, based on two weeks of countywide antibody testing and about 1,400 participants, found that about half of the people who tested positive for antibodies reported no symptoms in the 14-17 days before being tested. If the trend holds, the findings could have major implications for understanding not only the number of people infected, but also how many have symptoms and, in turn, how the virus spreads.
Erin Kobetz, a University of Miami professor of medicine and public health sciences and the lead researcher on the project, presented the findings along with Miami-Dade Mayor Carlos Gimenez during a press conference on Friday.
