Trial Outcomes & Findings for Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19 (NCT NCT04424901)
NCT ID: NCT04424901
Last Updated: 2023-04-21
Results Overview
Percent Change from Baseline \[Day Zero\] to last study measure (Day 3, Day 6 or Day 9)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
up to 9 days
Results posted on
2023-04-21
Participant Flow
Recruitment from Acute Care University Hospital Units May 2020 to March 2022
At Consent, subjects are randomized to Placebo or Dipyridamole group.
Participant milestones
| Measure |
Standard Care
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
17
|
16
|
Reasons for withdrawal
| Measure |
Standard Care
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
|---|---|---|
|
Overall Study
patients were discharged prior to Hospital Day 9
|
17
|
16
|
Baseline Characteristics
Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19
Baseline characteristics by cohort
| Measure |
Standard Care
n=21 Participants
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
n=20 Participants
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Age, Continuous
|
59.62 years
STANDARD_DEVIATION 14.06 • n=99 Participants
|
60.75 years
STANDARD_DEVIATION 13.89 • n=107 Participants
|
60.17 years
STANDARD_DEVIATION 13.81 • n=206 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
18 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black/African American
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Hispanic/Latino
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
COVID-19 -moderate or severe
|
21 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 9 daysPopulation: Percent Change from Baseline
Percent Change from Baseline \[Day Zero\] to last study measure (Day 3, Day 6 or Day 9)
Outcome measures
| Measure |
Standard Care
n=17 Participants
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
n=16 Participants
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
|---|---|---|
|
D-dimer
|
2.99 Percent Change of D-Dimer (ng/mL)
Interval -17.12 to 85.63
|
-10.09 Percent Change of D-Dimer (ng/mL)
Interval -22.06 to 6.08
|
PRIMARY outcome
Timeframe: up to 9 daysPopulation: Percent Change (%) from Baseline
Percent Change from Baseline \[Day Zero\] to last study measure (Day 3, Day 6 or Day 9)
Outcome measures
| Measure |
Standard Care
n=17 Participants
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
n=15 Participants
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
|---|---|---|
|
Platelet Count
|
27.45 Percent Change of 10^3 Platelets/uL
Standard Deviation 34.94
|
35.48 Percent Change of 10^3 Platelets/uL
Standard Deviation 37.52
|
SECONDARY outcome
Timeframe: 9 daysEvaluate for a non-detection from nasopharyngeal swab and in stool
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 daysSurvival Status Alive
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 daysChange in the markers CRP/Ferritin
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 daysChange in Lymphocyte Count/ Fibrinogen/Cardiac Troponin
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 daysCoagulation System
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 daysChange in SpO2/ imaging
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 9 daysChange in fever, cough, sputum
Outcome measures
Outcome data not reported
Adverse Events
Standard Care
Serious events: 5 serious events
Other events: 9 other events
Deaths: 2 deaths
Standard Care With Dipyridamole
Serious events: 7 serious events
Other events: 8 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Standard Care
n=21 participants at risk
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
n=20 participants at risk
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
|---|---|---|
|
General disorders
Death NOS
|
9.5%
2/21 • Number of events 2 • Mortality assessed up to 30 days beyond date of enrollment
|
10.0%
2/20 • Number of events 2 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/21 • Mortality assessed up to 30 days beyond date of enrollment
|
10.0%
2/20 • Number of events 2 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Investigations
Alanine Aminotransferase increased
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
0.00%
0/20 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/21 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/21 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
0.00%
0/20 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.00%
0/21 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/21 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
Other adverse events
| Measure |
Standard Care
n=21 participants at risk
Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
|
Standard Care With Dipyridamole
n=20 participants at risk
For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected.
Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses.
Data collection ends on day 9.
Dipyridamole: Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
|
|---|---|---|
|
Nervous system disorders
Headache
|
23.8%
5/21 • Number of events 5 • Mortality assessed up to 30 days beyond date of enrollment
|
20.0%
4/20 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
|
General disorders
Fever
|
19.0%
4/21 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
20.0%
4/20 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Investigations
Increase Alanine Aminotransferase
|
9.5%
2/21 • Number of events 2 • Mortality assessed up to 30 days beyond date of enrollment
|
20.0%
4/20 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
23.8%
5/21 • Number of events 5 • Mortality assessed up to 30 days beyond date of enrollment
|
10.0%
2/20 • Number of events 2 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Investigations
Increase Aspartate Aminotransferase
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
20.0%
4/20 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Vascular disorders
Hypotension
|
9.5%
2/21 • Number of events 2 • Mortality assessed up to 30 days beyond date of enrollment
|
20.0%
4/20 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
|
General disorders
Pain
|
19.0%
4/21 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
15.0%
3/20 • Number of events 3 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Vascular disorders
Hypertension
|
19.0%
4/21 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Cardiac disorders
Sinus Tachycardia
|
14.3%
3/21 • Number of events 3 • Mortality assessed up to 30 days beyond date of enrollment
|
15.0%
3/20 • Number of events 6 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Cardiac disorders
Sinus Bradycardia
|
19.0%
4/21 • Number of events 4 • Mortality assessed up to 30 days beyond date of enrollment
|
15.0%
3/20 • Number of events 3 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Cardiac disorders
Atrial Fibrillation
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Investigations
Platelet Count decreased
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.8%
1/21 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
5.0%
1/20 • Number of events 1 • Mortality assessed up to 30 days beyond date of enrollment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place