Trial Outcomes & Findings for Covid-19 Associated Coagulopathy (NCT NCT04360824)
NCT ID: NCT04360824
Last Updated: 2023-03-01
Results Overview
All-cause mortality
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
176 participants
Primary outcome timeframe
30 Days post intervention
Results posted on
2023-03-01
Participant Flow
Participant milestones
| Measure |
Active Comparator: Standard of Care
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Other: Interventional
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Overall Study
STARTED
|
88
|
88
|
|
Overall Study
COMPLETED
|
85
|
84
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Active Comparator: Standard of Care
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Other: Interventional
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Did not receive assigned treatment
|
1
|
3
|
Baseline Characteristics
Covid-19 Associated Coagulopathy
Baseline characteristics by cohort
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin (40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Total
n=173 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
47 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Continuous
|
63.5 years
n=5 Participants
|
65 years
n=7 Participants
|
64 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
63 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
86 participants
n=5 Participants
|
87 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
Median BMI - kg/m^2
|
30.7 kg/m^2
n=5 Participants
|
30.0 kg/m^2
n=7 Participants
|
30.5 kg/m^2
n=5 Participants
|
|
BMI ≥ 30 kg/m^2
|
56 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Time from COVID-19 test to enrollment
|
4.5 Days
n=5 Participants
|
5 Days
n=7 Participants
|
5 Days
n=5 Participants
|
|
Coexisting Conditions
Cancer
|
13 participants
n=5 Participants
|
7 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Coexisting Conditions
Diabetes mellitus
|
34 participants
n=5 Participants
|
30 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Coexisting Conditions
Heart Disease
|
27 participants
n=5 Participants
|
27 participants
n=7 Participants
|
54 participants
n=5 Participants
|
|
Coexisting Conditions
Hypertension
|
53 participants
n=5 Participants
|
51 participants
n=7 Participants
|
104 participants
n=5 Participants
|
|
Coexisting Conditions
Lung Disease
|
19 participants
n=5 Participants
|
20 participants
n=7 Participants
|
39 participants
n=5 Participants
|
|
Coexisting Conditions
Obesity
|
39 participants
n=5 Participants
|
45 participants
n=7 Participants
|
84 participants
n=5 Participants
|
|
Coexisting Conditions
Current or former smoker
|
38 participants
n=5 Participants
|
35 participants
n=7 Participants
|
73 participants
n=5 Participants
|
|
Coexisting Conditions
Admitted to ICU
|
54 participants
n=5 Participants
|
53 participants
n=7 Participants
|
107 participants
n=5 Participants
|
|
Lab Value: D-dimer
|
1900 ng/mL fibrinogen equivalent units
n=5 Participants
|
1570 ng/mL fibrinogen equivalent units
n=7 Participants
|
1680 ng/mL fibrinogen equivalent units
n=5 Participants
|
|
Lab Value: Prothrombin time
|
11 seconds
n=5 Participants
|
11 seconds
n=7 Participants
|
11 seconds
n=5 Participants
|
|
Lab Value: Fibrinogen
|
552 mg/dL
n=5 Participants
|
543 mg/dL
n=7 Participants
|
552 mg/dL
n=5 Participants
|
|
Lab Value: Platelet count
|
270 10^9 platelets/L
n=5 Participants
|
257 10^9 platelets/L
n=7 Participants
|
261 10^9 platelets/L
n=5 Participants
|
|
Lab Value: Absolute lymphocyte count
|
735 10^6 cells/L
n=5 Participants
|
800 10^6 cells/L
n=7 Participants
|
781 10^6 cells/L
n=5 Participants
|
|
Other treatments for COVID-19
Azithromycin
|
11 participants
n=5 Participants
|
25 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Other treatments for COVID-19
Convalescent
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Other treatments for COVID-19
Corticosteroids
|
67 participants
n=5 Participants
|
63 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Other treatments for COVID-19
Famotidine
|
30 participants
n=5 Participants
|
25 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Other treatments for COVID-19
Remdesivir
|
54 participants
n=5 Participants
|
51 participants
n=7 Participants
|
105 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 Days post interventionPopulation: From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
All-cause mortality
Outcome measures
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Mortality
|
18 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 30 days post interventionPopulation: From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
Defined as an estimated creatinine clearance \<30 mL/min
Outcome measures
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Number of Participants With Acute Kidney Injury
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 30 Days post interventionPopulation: From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
Risk of ischemic stroke, myocardial infarction and/or limb ischemia
Outcome measures
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Number of Participants With Arterial Thrombosis
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 Days post interventionPopulation: From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
Those at risk of symptomatic venous thromboembolism, which is a blood clot in a vein.
Outcome measures
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Number of Participants With Venous Thrombosis
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 30 Days post interventionPopulation: From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
Those at risk of ISTH defined major bleeding, such as fatal bleeding, or bleeding into a critical area or organ.
Outcome measures
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Number of Participants With Major Bleeding
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 30 Days post interventionPopulation: From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
Defined as a bleeding event that did not meet ISTH criteria for major bleeding.
Outcome measures
| Measure |
Standard of Care
n=86 Participants
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin ( 40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 Participants
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Number of Participants With Minor Bleeding
|
6 Participants
|
6 Participants
|
Adverse Events
Standard of Care
Serious events: 32 serious events
Other events: 0 other events
Deaths: 18 deaths
Interventional
Serious events: 31 serious events
Other events: 0 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Standard of Care
n=86 participants at risk
Patients randomized to the standard of care arm will received standard prophylactic dose enoxaparin (40mg subcutaneously daily if BMI \<30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30kg/m2).
|
Interventional
n=87 participants at risk
Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI \<30 kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
17.4%
15/86 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
12.6%
11/87 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
|
Blood and lymphatic system disorders
Arterial thrombosis
|
3.5%
3/86 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
5.7%
5/87 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
|
Blood and lymphatic system disorders
Venous thrombosis
|
7.0%
6/86 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
8.0%
7/87 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
|
Blood and lymphatic system disorders
Major bleeding
|
2.3%
2/86 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
2.3%
2/87 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
|
Blood and lymphatic system disorders
Minor bleeding
|
7.0%
6/86 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
6.9%
6/87 • 30 Days
From 88 starting in Standard of Care group, 2 withdrew prior to treatment leaving 86 remaining. From 88 starting in Interventional group, 1 withdrew prior to treatment leaving 87 remaining.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Usha Perepu
University of Iowa Hospitals & Clinics
Phone: 1-319-356-2195
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place