Michael Coston
Editor, Senior Moderator
RECOVERY Convalescent Plasma Trial Closes Recruitment Of Hospitalized COVID Patients
#15,719
For the second time in less than a week (see Tuesday's blog Another Convalescent Plasma Study Fails To Find Benefit For Severe COVID-19) a large clinical trial has failed to find benefit of convalescent plasma (CP) therapy in severely ill COVID patients.
This latest announcement comes from the convalescent plasma arm of the RECOVERY trial, which announced yesterday that there was no significant difference in the primary endpoint of 28-day mortality between patients who received CP therapy and those that did not.
An excerpt from their announcement follows.
RECOVERY trial closes recruitment to convalescent plasma treatment for patients hospitalised with COVID-19
15 January 2021
Statement from the RECOVERY trial chief investigators, 15 January 2021
The RECOVERY trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19. Since May 2020, the RECOVERY trial has included a randomised comparison of convalescent plasma vs. usual care alone. Convalescent plasma has been widely used as a treatment for COVID-19 but to date there has been no convincing evidence of the effect of convalescent plasma on clinical outcomes in patients admitted to hospital with COVID-19.
The RECOVERY trial independent Data Monitoring Committee (DMC) held a routine meeting on Thursday 14 January to review the available safety and efficacy data.
On the advice of the DMC, recruitment to the convalescent plasma arm of the RECOVERY trial has now closed. The DMC saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup.
The DMC reviewed data on patients randomised to convalescent plasma vs. usual care. The preliminary analysis based on 1873 reported deaths among 10,406 randomised patients shows no significant difference in the primary endpoint of 28-day mortality (18% convalescent plasma vs. 18% usual care alone; risk ratio 1.04 [95% confidence interval 0.95-1.14]; p=0.34). Follow-up of patients is ongoing and final results will be published as soon as possible.
Recruitment to all other treatment arms – tocilizumab, aspirin, colchicine, and Regeneron’s antibody cocktail – continues as planned.
(Continue . . . )
These two latest announcements come after two previous clinical trials came to pretty much the same conclusion (see BMJ: Clinical Trial On Convalescent Plasma Showed Little Benefit For COVID-19 and Dutch Convalescent Plasma Study For COVID-19 Halted For Redesign) in 2020.
While there are still hopes that the early administration of convalescent plasma in mildly ill patients might have some benefit (see NEJM Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults), the use of CP for severely ill patients has consistently underwhelmed.
For a more detailed run down on the history of success, and failures, with convalescent plasma you may wish to revisit 2019's The Lancet: Clinical Trial On Use of Convalescent Plasma To Treat Severe Influenza.
https://afludiary.blogspot.com/2021/...sma-trial.html
#15,719
For the second time in less than a week (see Tuesday's blog Another Convalescent Plasma Study Fails To Find Benefit For Severe COVID-19) a large clinical trial has failed to find benefit of convalescent plasma (CP) therapy in severely ill COVID patients.
This latest announcement comes from the convalescent plasma arm of the RECOVERY trial, which announced yesterday that there was no significant difference in the primary endpoint of 28-day mortality between patients who received CP therapy and those that did not.
An excerpt from their announcement follows.
RECOVERY trial closes recruitment to convalescent plasma treatment for patients hospitalised with COVID-19
15 January 2021
Statement from the RECOVERY trial chief investigators, 15 January 2021
The RECOVERY trial was established as a randomised clinical trial to test a range of potential treatments for COVID-19. Since May 2020, the RECOVERY trial has included a randomised comparison of convalescent plasma vs. usual care alone. Convalescent plasma has been widely used as a treatment for COVID-19 but to date there has been no convincing evidence of the effect of convalescent plasma on clinical outcomes in patients admitted to hospital with COVID-19.
The RECOVERY trial independent Data Monitoring Committee (DMC) held a routine meeting on Thursday 14 January to review the available safety and efficacy data.
On the advice of the DMC, recruitment to the convalescent plasma arm of the RECOVERY trial has now closed. The DMC saw no convincing evidence that further recruitment would provide conclusive proof of worthwhile mortality benefit either overall or in any pre-specified subgroup.
The DMC reviewed data on patients randomised to convalescent plasma vs. usual care. The preliminary analysis based on 1873 reported deaths among 10,406 randomised patients shows no significant difference in the primary endpoint of 28-day mortality (18% convalescent plasma vs. 18% usual care alone; risk ratio 1.04 [95% confidence interval 0.95-1.14]; p=0.34). Follow-up of patients is ongoing and final results will be published as soon as possible.
Recruitment to all other treatment arms – tocilizumab, aspirin, colchicine, and Regeneron’s antibody cocktail – continues as planned.
(Continue . . . )
These two latest announcements come after two previous clinical trials came to pretty much the same conclusion (see BMJ: Clinical Trial On Convalescent Plasma Showed Little Benefit For COVID-19 and Dutch Convalescent Plasma Study For COVID-19 Halted For Redesign) in 2020.
While there are still hopes that the early administration of convalescent plasma in mildly ill patients might have some benefit (see NEJM Early High-Titer Plasma Therapy to Prevent Severe Covid-19 in Older Adults), the use of CP for severely ill patients has consistently underwhelmed.
For a more detailed run down on the history of success, and failures, with convalescent plasma you may wish to revisit 2019's The Lancet: Clinical Trial On Use of Convalescent Plasma To Treat Severe Influenza.
https://afludiary.blogspot.com/2021/...sma-trial.html