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RECOVERY Trial: Aspirin Does Not Improve Survival For Hospitalized COVID Patients
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#16,005
Throughout the nearly 18 months since COVID-19 first appeared we've seen a number of supposed cures and treatments touted - often with anecdotal evidence of their effectiveness - that ultimately failed to produce the desired results in clinical trials.
A short list of blogs on some of these more promising would-be COVID-killers, include:
RECOVERY Convalescent Plasma Trial Closes Recruitment Of Hospitalized COVID Patients
BMJ Open: Association Between Statin Use And Outcomes in Patients with COVID-19
Another Convalescent Plasma Study Fails To Find Benefit For Severe COVID-19
Eli Lilly & ViralClear Halt Clinical Trials For COVID-19 Treatments
WHO Solidarity Therapeutics Trial: Remdesivir, HCQ, Lopinar/Ritonavir & Interferon Disappoint
Although COVID vaccines have proven to be a remarkable success, developing effective therapeutics for viral infections have always been a challenge.
The latest COVID treatment to fall short appears to be Aspirin (ASA), whose anticoagulating properties would seem likely to be beneficial to COVID patients, and which has the added benefit of low cost and nearly universal access.
Unfortunately, this week's announcement from the RECOVERY TRIAL found no such benefit.
6 June 2021
The RECOVERY trial was established as a randomised clinical trial to test a range of potential treatments for patients hospitalised with COVID-19. Patients with COVID-19 are at increased risk of blood clots forming in their blood vessels, particularly in the lungs. Between November 2020 and March 2021, the RECOVERY trial included nearly 15,000 patients hospitalised with COVID-19 in an assessment of the effects of aspirin, which is widely used to reduce blood clotting in other diseases.
A total of 7351 patients were randomised to aspirin 150 mg once daily and compared with 7541 patients randomised to usual care alone. There was no evidence that aspirin treatment reduced mortality. There was no significant difference in the primary endpoint of 28-day mortality (17% aspirin vs. 17% usual care; rate ratio 0.96 [95% confidence interval 0.89-1.04]; p=0.35). The results were consistent in all pre-specified subgroups of patients.
Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1·06; 95% CI 1·02-1·10; p=0·0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who progressed to invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0·96; 95% CI 0·90-1·03; p=0·23). For every 1000 patients treated with aspirin, approximately 6 more patients experienced a major bleeding event and approximately 6 fewer experienced a thromboembolic (clotting) event.
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the RECOVERY trial, said: ‘The data show that in patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death. Although aspirin was associated with a small increase in the likelihood of being discharged alive this does not seem to be sufficient to justify its widespread use for patients hospitalised with COVID-19.’
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Joint Chief Investigator, said ‘There has been a strong suggestion that blood clotting may be responsible for deteriorating lung function and death in patients with severe COVID-19. Aspirin is inexpensive and widely used in other diseases to reduce the risk of blood clots so it is disappointing that it did not have a major impact for these patients. This is why large randomised trials are so important – to establish which treatments work and which do not. As ever, we are enormously grateful to the thousands of medical staff and patients who have contributed to the RECOVERY trial, helping to find better treatments for patients all around the world.’
The results of this evaluation of aspirin have been published today on medRxiv and have been submitted to a leading peer-reviewed medical journal.
Credit Wikipedia
#16,005
Throughout the nearly 18 months since COVID-19 first appeared we've seen a number of supposed cures and treatments touted - often with anecdotal evidence of their effectiveness - that ultimately failed to produce the desired results in clinical trials.
A short list of blogs on some of these more promising would-be COVID-killers, include:
RECOVERY Convalescent Plasma Trial Closes Recruitment Of Hospitalized COVID Patients
BMJ Open: Association Between Statin Use And Outcomes in Patients with COVID-19
Another Convalescent Plasma Study Fails To Find Benefit For Severe COVID-19
Eli Lilly & ViralClear Halt Clinical Trials For COVID-19 Treatments
WHO Solidarity Therapeutics Trial: Remdesivir, HCQ, Lopinar/Ritonavir & Interferon Disappoint
Although COVID vaccines have proven to be a remarkable success, developing effective therapeutics for viral infections have always been a challenge.
The latest COVID treatment to fall short appears to be Aspirin (ASA), whose anticoagulating properties would seem likely to be beneficial to COVID patients, and which has the added benefit of low cost and nearly universal access.
Unfortunately, this week's announcement from the RECOVERY TRIAL found no such benefit.
6 June 2021
The RECOVERY trial was established as a randomised clinical trial to test a range of potential treatments for patients hospitalised with COVID-19. Patients with COVID-19 are at increased risk of blood clots forming in their blood vessels, particularly in the lungs. Between November 2020 and March 2021, the RECOVERY trial included nearly 15,000 patients hospitalised with COVID-19 in an assessment of the effects of aspirin, which is widely used to reduce blood clotting in other diseases.
A total of 7351 patients were randomised to aspirin 150 mg once daily and compared with 7541 patients randomised to usual care alone. There was no evidence that aspirin treatment reduced mortality. There was no significant difference in the primary endpoint of 28-day mortality (17% aspirin vs. 17% usual care; rate ratio 0.96 [95% confidence interval 0.89-1.04]; p=0.35). The results were consistent in all pre-specified subgroups of patients.
Patients allocated to aspirin had a slightly shorter duration of hospitalisation (median 8 days vs. 9 days) and a higher proportion were discharged from hospital alive within 28 days (75% vs. 74%; rate ratio 1·06; 95% CI 1·02-1·10; p=0·0062). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion who progressed to invasive mechanical ventilation or death (21% vs. 22%; risk ratio 0·96; 95% CI 0·90-1·03; p=0·23). For every 1000 patients treated with aspirin, approximately 6 more patients experienced a major bleeding event and approximately 6 fewer experienced a thromboembolic (clotting) event.
Peter Horby, Professor of Emerging Infectious Diseases in the Nuffield Department of Medicine, University of Oxford, and Joint Chief Investigator for the RECOVERY trial, said: ‘The data show that in patients hospitalised with COVID-19, aspirin was not associated with reductions in 28-day mortality or in the risk of progressing to invasive mechanical ventilation or death. Although aspirin was associated with a small increase in the likelihood of being discharged alive this does not seem to be sufficient to justify its widespread use for patients hospitalised with COVID-19.’
Martin Landray, Professor of Medicine and Epidemiology at the Nuffield Department of Population Health, University of Oxford, and Joint Chief Investigator, said ‘There has been a strong suggestion that blood clotting may be responsible for deteriorating lung function and death in patients with severe COVID-19. Aspirin is inexpensive and widely used in other diseases to reduce the risk of blood clots so it is disappointing that it did not have a major impact for these patients. This is why large randomised trials are so important – to establish which treatments work and which do not. As ever, we are enormously grateful to the thousands of medical staff and patients who have contributed to the RECOVERY trial, helping to find better treatments for patients all around the world.’
The results of this evaluation of aspirin have been published today on medRxiv and have been submitted to a leading peer-reviewed medical journal.
Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
Peter W Horby, Guilherme Pessoa-Amorim, Natalie Staplin, Jonathan R Emberson, Enti Spata, Mark Campbell, Leon Peto, Nigel Brunskill, Simon Tiberi, Victor Chew, Thomas Brown, Hasan Tahir, Beate Ebert, David R Chadwick, Tony Whitehouse, Rahuldeb Sarkar, Jonathan Clive Graham, Kenneth Baillie, Buddha Basnyat, Maya H Buch, Lucy C Chappell, Jeremy N Day, Saul N Faust,Raph Hamers, Thomas Jaki, Katie Jeffery, Edmund Juszczak, Wei Shen Lim, Alan Montgomery, Andrew Mumford, Kathryn Rowan, Guy Thwaites, Marion Mafham, Richard Haynes, Martin J Landray
doi: https://doi.org/10.1101/2021.06.08.21258132
Peter W Horby, Guilherme Pessoa-Amorim, Natalie Staplin, Jonathan R Emberson, Enti Spata, Mark Campbell, Leon Peto, Nigel Brunskill, Simon Tiberi, Victor Chew, Thomas Brown, Hasan Tahir, Beate Ebert, David R Chadwick, Tony Whitehouse, Rahuldeb Sarkar, Jonathan Clive Graham, Kenneth Baillie, Buddha Basnyat, Maya H Buch, Lucy C Chappell, Jeremy N Day, Saul N Faust,Raph Hamers, Thomas Jaki, Katie Jeffery, Edmund Juszczak, Wei Shen Lim, Alan Montgomery, Andrew Mumford, Kathryn Rowan, Guy Thwaites, Marion Mafham, Richard Haynes, Martin J Landray
doi: https://doi.org/10.1101/2021.06.08.21258132
