Trial Outcomes & Findings for Aggrenox To Treat Acute Covid-19 (NCT NCT04410328)
NCT ID: NCT04410328
Last Updated: 2025-02-21
Results Overview
Change in composite COVID ordinal scale from day 1 to 14. Ordinal scale: 1) not hospitalized with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen; 4) hospitalized, requiring oxygen; 5) hospitalized, requiring high-flow oxygen therapy, or noninvasive ventilation; 6) hospitalized, requiring invasive ventilation; 7) ventilation plus additional organ support such as pressors, renal replacement therapy and ECMO and 8) death. COVID Ordinal Scale ranges from 1 to 8, with score 1 on the scale corresponds to an ambulatory patient with minimal symptoms and score 8 on the scale corresponds to death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
98 participants
Primary outcome timeframe
15 days
Results posted on
2025-02-21
Participant Flow
Participant milestones
| Measure |
Participants Receiving Dipyridamole and Aspirin
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care treatment consist of an intravenous Remidesivir 200 mg loading dose and then 100 mg/daily for a total of 4 days for non-intubated patients and 10 days for intubated patients, intravenous/oral decadron 6 mg/daily for 10 days and prophylactic subcutaneous LMWH daily, started on the day of enrollment and for the duration of hospitalization. If the patients are discharged before 10 days, they are prescribed oral decadron 6 mg daily to complete the course of 10 days
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|---|---|---|
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Overall Study
STARTED
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49
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49
|
|
Overall Study
COMPLETED
|
49
|
49
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Aggrenox To Treat Acute Covid-19
Baseline characteristics by cohort
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Total
n=98 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
57.5 years
n=5 Participants
|
56 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
West Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal/First Nations
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Mixed
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0 Participants
n=5 Participants
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1 Participants
n=7 Participants
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1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
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2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
49 participants
n=5 Participants
|
49 participants
n=7 Participants
|
98 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 15 daysChange in composite COVID ordinal scale from day 1 to 14. Ordinal scale: 1) not hospitalized with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen; 4) hospitalized, requiring oxygen; 5) hospitalized, requiring high-flow oxygen therapy, or noninvasive ventilation; 6) hospitalized, requiring invasive ventilation; 7) ventilation plus additional organ support such as pressors, renal replacement therapy and ECMO and 8) death. COVID Ordinal Scale ranges from 1 to 8, with score 1 on the scale corresponds to an ambulatory patient with minimal symptoms and score 8 on the scale corresponds to death.
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Covid (Coronavirus Disease-19) Ordinal Scale
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2.3 score on a scale
Standard Deviation 1.8
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2.1 score on a scale
Standard Deviation 2.0
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SECONDARY outcome
Timeframe: 14 daysAll-cause mortality assessed on day 14.
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Mortality
|
2 Participants
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2 Participants
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SECONDARY outcome
Timeframe: 28 daysAll-cause mortality assessed on day 28.
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Mortality
|
3 Participants
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5 Participants
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SECONDARY outcome
Timeframe: Baseline and 7 daysChange in marker D-dimer
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Inflammatory Marker Between Baseline and 7 Days
|
-197.5 ng/mL
Interval -2425.0 to 366.0
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114 ng/mL
Interval -1408.0 to 240.0
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SECONDARY outcome
Timeframe: 28 daysCOVID ordinal scale
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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COVID Ordinal Scale
|
3 scores on a scale
Interval 2.0 to 4.0
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3 scores on a scale
Interval 2.0 to 3.0
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SECONDARY outcome
Timeframe: 28 daysnumber of participants who received supplemental oxygen or those with supplemental oxygen-free days
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Number of Participants Not Requiring Supplemental Oxygen
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45 Participants
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43 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of participants who were invasive-ventilator free
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Invasive-ventilator
|
4 Participants
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5 Participants
|
SECONDARY outcome
Timeframe: 28 daysNumber of participants admitted to ICU
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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ICU Stay
|
5 Participants
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7 Participants
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SECONDARY outcome
Timeframe: Baseline and 7 daysIncrease in marker Ferritin
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Inflammatory Marker
|
652.5 ug/L
Interval 312.0 to 1752.0
|
381 ug/L
Interval 115.0 to 521.0
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SECONDARY outcome
Timeframe: Baseline and 7 daysIncrease in marker C-reactive protein
Outcome measures
| Measure |
Participants Receiving Dipyridamole and Aspirin
n=49 Participants
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Standard of Care
n=49 Participants
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
|---|---|---|
|
Inflammatory Marker
|
92 ug/L
Interval 83.0 to 101.0
|
165 ug/L
Interval 85.0 to 262.0
|
Adverse Events
Participants Receiving Standard of Care
Serious events: 7 serious events
Other events: 0 other events
Deaths: 7 deaths
Participants Receiving Dipyridamole and Aspirin
Serious events: 5 serious events
Other events: 0 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Participants Receiving Standard of Care
n=49 participants at risk
Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
|
Participants Receiving Dipyridamole and Aspirin
n=49 participants at risk
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
Standard of care: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
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|---|---|---|
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Infections and infestations
death
|
14.3%
7/49 • Adverse event data were collected over a period of 28 days.
Study participants death was a result of their diagnosis and not due to the study intervention.
|
10.2%
5/49 • Adverse event data were collected over a period of 28 days.
Study participants death was a result of their diagnosis and not due to the study intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place