Median time from diagnosis to randomization: 7 days
Median time from randomization to initiation of treatment: 3 days
The study was terminated early because of lower than anticipated event rate
Primary composite end point
Aspirin: 1 patient (0.7%) in the aspirin group
2.5-mg apixaban group: 1 patient (0.7%)
5-mg apixaban group: 2 patients (1.4%)
Placebo: 1 patient (0.7%)
There was no significant difference in primary composite outcome between the groups against placebo reference
Aspirin: Risk difference (RD): 0.00 (CI not calculable)
2.5-mg apixaban: RD 0.7% (95% CI, –2.1% to 4.1%)
5-mg apixaban: RD 1.4% (95% CI, –1.5% to 5.0%)
Risk differences compared to placebo for bleeding events were slightly higher among the treatment groups
Aspirin: RD 2.0% (95% CI, –2.7% to 6.8%)
2.5-mg apixaban: RD 4.5% (95% CI, –0.7% to 10.2%)
5-mg apixaban: RD 6.9% (95% CI, 1.4% to 12.9%)
Treatment with apixaban or aspirin in outpatients with COVID-19 did not reduce the incidence of a composite of adverse cardiopulmonary clinical outcomes compared to placebo
However, the trial was terminated early due to lower than anticipated event rates
The authors suggest the following reasons for low event rates
…the threshold for hospital admission has markedly declined since the beginning of the pandemic…As a result, the severity of illness among individuals with COVID-19 and destined for outpatient care has declined
…at least within the US where the trial was conducted, individuals currently being infected with SARS-CoV-2 tend to be younger and have fewer comorbidities when compared with individuals with incident infection at the onset of the pandemic
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