Trial Outcomes & Findings for COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 (NCT NCT04498273)
NCT ID: NCT04498273
Last Updated: 2022-02-17
Results Overview
The primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
657 participants
Primary outcome timeframe
45 days
Results posted on
2022-02-17
Participant Flow
Participants were enrolled from a variety of different facilities where (a) a clinician can evaluate the patient for inclusion and exclusion criteria, and (b) where blood samples can be arranged to be sent for D-dimer, hsCRP, calculated creatinine clearance, and platelet count. COVID-19 testing needs to be confirmed positive within the past 14 days. Serum or urine pregnancy test results will be required for women of childbearing potential before starting study treatment.
Participant milestones
| Measure |
Apixaban 2.5mg
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
|
Apixaban 5mg
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
|
Asprin
Antiplatelet agent: low dose aspirin 81mg po qd
|
Placebo
Only Placebo
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
165
|
164
|
164
|
164
|
|
Overall Study
COMPLETED
|
134
|
140
|
143
|
133
|
|
Overall Study
NOT COMPLETED
|
31
|
24
|
21
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
Baseline characteristics by cohort
| Measure |
Apixaban 2.5mg
n=165 Participants
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
|
Apixaban 5mg
n=164 Participants
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
|
Asprin
n=164 Participants
Antiplatelet agent: low dose aspirin 81mg po qd
|
Placebo
n=164 Participants
Only Placebo
|
Total
n=657 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55 years
n=99 Participants
|
52 years
n=107 Participants
|
54 years
n=206 Participants
|
54 years
n=7 Participants
|
52 years
n=31 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
96 Participants
n=7 Participants
|
388 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
68 Participants
n=7 Participants
|
269 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
78 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
124 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
131 Participants
n=7 Participants
|
494 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
15 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
69 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
165 participants
n=99 Participants
|
164 participants
n=107 Participants
|
164 participants
n=206 Participants
|
164 participants
n=7 Participants
|
657 participants
n=31 Participants
|
PRIMARY outcome
Timeframe: 45 daysThe primary outcome will be a composite endpoint of need for hospitalization for cardiovascular/pulmonary events, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, ischemic stroke, and all-cause mortality for up to 45 days after initiation of assigned treatment.
Outcome measures
| Measure |
Apixaban 2.5mg
n=165 Participants
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
|
Apixaban 5mg
n=164 Participants
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
|
Asprin
n=164 Participants
Antiplatelet agent: low dose aspirin 81mg po qd
|
Placebo
n=164 Participants
only Placebo
|
|---|---|---|---|---|
|
Hospitalization for Cardiovascular/Pulmonary Events
|
1 participants
Interval -2.1 to 4.1
|
1 participants
Interval -1.5 to 5.0
|
0 participants
Interval -0.7 to 10.2
|
0 participants
Interval -2.7 to 6.8
|
Adverse Events
Apixaban 2.5mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Apixaban 5mg
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Asprin
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Apixaban 2.5mg
n=165 participants at risk
Anticoagulation: prophylactic dose Apixaban 2.5mg po bid
|
Apixaban 5mg
n=164 participants at risk
Anticoagulation: therapeutic dose Apixaban 5.0mg po bid
|
Asprin
n=164 participants at risk
Antiplatelet agent: low dose aspirin 81mg po qd
|
Placebo
n=164 participants at risk
only Placebo
|
|---|---|---|---|---|
|
Investigations
Non-major Bleeding
|
5.5%
9/165 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
7.9%
13/164 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
3.7%
6/164 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
1.8%
3/164 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
|
Reproductive system and breast disorders
Admitted for pneumonia
|
0.61%
1/165 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
1.2%
2/164 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/164 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
0.00%
0/164 • a 45-day treatment period
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place