BACKGROUND AND PURPOSE:

• The RECOVERY Collaborative Group (The Lancet, 2021) evaluated the efficacy and safety of aspirin in patients admitted to hospital with COVID-19

METHODS:

• Randomized, controlled, open-label, platform trial
  • UK (117 hospitals) | Indonesia (2 hospitals) | Nepal (2 hospitals)
• Participants
  • Patients hospitalized with COVID-19
• Interventions
  • Usual care
  • Usual care plus 150 mg aspirin once daily until discharge
• Study design
  • All analyses were by intention to treat
  • Trial steering committee determined that study would end when enough patients enrolled to provide ≥90% power at a two-sided significance level of 1% to detect a clinically relevant proportional reduction in 28 day mortality of 12.5% between the two groups
  • Subgroup analysis: Age | Sex | Ethnicity | Amount of respiratory support | Days since symptom onset | Use of corticosteroids
• Primary outcome
  • 28-day mortality
• Secondary outcome
  • Composite: Progression to invasive mechanical ventilation or death within 28 days
  • Among patients not receiving invasive mechanical ventilation at randomization

RESULTS:

• Aspirin group: 7351 patients | Usual care group: 7541 patients
• There was no difference in 28-day mortality between the groups
  • Aspirin group: 17%
  • Usual care group: 17%
  • Rate ratio (RR) 0.96 (95% CI, 0.89 to 1.04); P=0.35
  • Results consistent in all prespecified patient subgroups
• Patients is aspirin group had slightly shorter duration of hospitalization
  • Aspirin: median (IQR) 8 (5 to >28) days
  • Usual care: 9 (5 to >28) days
• A higher proportion of aspirin patients were discharged from the hospital alive within 28 days
  • Aspirin: 75%
  • Usual care: 74%
  • Rate ratio 1.06 (95% CI, 1.02 to 1.10); P=0.0062
• There was not difference for secondary composite outcome (invasive mechanical ventilation or death)
  • Aspirin: 21%
  • Usual care: 22%
  • Risk ratio 0.96 (95% CI, 0.90 to 1.03); P=0.23
• Aspirin use was associated with
  • A reduction in thrombotic events
    • Aspirin: 4.6%
    • Usual care: 5.3%
    • Absolute reduction 0.6%
  • An increase in major bleeding events
    • Aspirin: 1.6%
    • Usual care: 1.0%
    • Absolute increase 0.6%

CONCLUSION:

• Aspirin did not reduce 28-day mortality among patients hospitalized for COVID-19
• There was a small increase in the rate of discharge at 28 days but also an increase in bleeding events
• The authors state

In summary, the results of this large, randomised trial do not support the addition of aspirin to standard thromboprophylaxis or therapeutic anticoagulation in patients hospitalised with COVID-19 

Learn More – Primary Sources:

Aspirin in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

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