Trial Outcomes & Findings for Cardiovascular Effects of COVID-19 (NCT NCT04365699)
NCT ID: NCT04365699
Last Updated: 2021-09-16
Results Overview
Data collection from medical chart review
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
Day 45
Results posted on
2021-09-16
Participant Flow
Participant milestones
| Measure |
Interventional Patients: AT-001
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement \>200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
|
Control Match Group 1
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
|
Control Match Group 2
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
16
|
55
|
|
Overall Study
COMPLETED
|
8
|
11
|
40
|
|
Overall Study
NOT COMPLETED
|
2
|
5
|
15
|
Reasons for withdrawal
| Measure |
Interventional Patients: AT-001
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement \>200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
|
Control Match Group 1
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
|
Control Match Group 2
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
|
|---|---|---|---|
|
Overall Study
Death
|
2
|
5
|
15
|
Baseline Characteristics
Cardiovascular Effects of COVID-19
Baseline characteristics by cohort
| Measure |
Interventional Patients: AT-001
n=10 Participants
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement \>200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
|
Control Match Group 1
n=16 Participants
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
|
Control Match Group 2
n=55 Participants
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
66.4 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
65 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
64.5 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 5.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
16 participants
n=7 Participants
|
55 participants
n=5 Participants
|
81 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 45Data collection from medical chart review
Outcome measures
| Measure |
Interventional Patients: AT-001
n=10 Participants
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement \>200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
|
Control Match Group 1
n=16 Participants
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
|
Control Match Group 2
n=55 Participants
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
|
|---|---|---|---|
|
Hospital Length of Stay (LOS)
|
5 days
Interval 4.0 to 29.0
|
10 days
Interval 5.0 to 20.0
|
25 days
Interval 16.0 to 36.0
|
PRIMARY outcome
Timeframe: Day 45Data collection from medical chart review
Outcome measures
| Measure |
Interventional Patients: AT-001
n=10 Participants
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement \>200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
|
Control Match Group 1
n=16 Participants
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
|
Control Match Group 2
n=55 Participants
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
|
|---|---|---|---|
|
Percentage of Participants Who Died
|
20 percentage of participants
|
31.3 percentage of participants
|
27.3 percentage of participants
|
Adverse Events
Interventional Patients: AT-001
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Control Match Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 5 deaths
Control Match Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 15 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Interventional Patients: AT-001
n=10 participants at risk
Patients enrolled in registry from NYU Langone Tisch Hospital with history of diabetes mellitus and/or acute hyperglycemia (any glucose measurement \>200 mg/dl) and evidence of acute or chronic heart disease. This subset will receive Standard of Care + AT-001.
AT-001: Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
|
Control Match Group 1
n=16 participants at risk
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The first matching approach selected all subjects with diabetes mellitus and hypertension, and available data to match participants who received AT-001 for gender, age group (in bins of 5 years), weight, and C-reactive protein (CRP) value at the time of hospital admission.
|
Control Match Group 2
n=55 participants at risk
Matched control from a contemporaneous de-identified registry of hospitalized patients with clinical COVID-19 diagnosis at the same institution was selected. The second matching approach selected all subjects in the registry with diabetes mellitus and available data to match participants who received AT-001 for gender, age group (in bings of 5 years), and weight (+/- 0.5 kgs).
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea / Upset GI
|
20.0%
2/10 • 45 days
|
0.00%
0/16 • 45 days
|
0.00%
0/55 • 45 days
|
|
Skin and subcutaneous tissue disorders
Localized Skin Rash
|
10.0%
1/10 • 45 days
|
0.00%
0/16 • 45 days
|
0.00%
0/55 • 45 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place