Trial Outcomes & Findings for Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19) (NCT NCT04355143)
NCT ID: NCT04355143
Last Updated: 2022-11-03
Results Overview
Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
93 participants
Primary outcome timeframe
90 Days
Results posted on
2022-11-03
Participant Flow
Of 304 screened individuals that met inclusion criteria,169 met exclusion criteria, 11 had co-enrollment conflicts with other clinical trials, 31 declined to participate.
Participant milestones
| Measure |
Colchicine Plus Current Care
Colchicine 0.6 mg po BID (twice a day) x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
45
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants for whom BMI measurements were recorded at baseline.
Baseline characteristics by cohort
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
Total
n=93 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
71.2 years
STANDARD_DEVIATION 17 • n=48 Participants
|
71.5 years
STANDARD_DEVIATION 19.5 • n=45 Participants
|
71.3 years
STANDARD_DEVIATION 18.2 • n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=48 Participants
|
21 Participants
n=45 Participants
|
30 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=48 Participants
|
24 Participants
n=45 Participants
|
63 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
White
|
28 Participants
n=48 Participants
|
21 Participants
n=45 Participants
|
49 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=48 Participants
|
4 Participants
n=45 Participants
|
6 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Other
|
18 Participants
n=48 Participants
|
20 Participants
n=45 Participants
|
38 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=48 Participants
|
45 participants
n=45 Participants
|
93 participants
n=93 Participants
|
|
Clinical Risk Factors
Hypertension
|
39 Participants
n=48 Participants
|
34 Participants
n=45 Participants
|
73 Participants
n=93 Participants
|
|
Clinical Risk Factors
Hyperlipidemia
|
35 Participants
n=48 Participants
|
23 Participants
n=45 Participants
|
58 Participants
n=93 Participants
|
|
Clinical Risk Factors
Diabetes
|
19 Participants
n=48 Participants
|
16 Participants
n=45 Participants
|
35 Participants
n=93 Participants
|
|
Clinical Risk Factors
Tobacco use (current or former)
|
14 Participants
n=48 Participants
|
19 Participants
n=45 Participants
|
33 Participants
n=93 Participants
|
|
Clinical Risk Factors
Cerebrovascular Disease
|
4 Participants
n=48 Participants
|
8 Participants
n=45 Participants
|
12 Participants
n=93 Participants
|
|
Clinical Risk Factors
Chronic Kidney Disease
|
18 Participants
n=48 Participants
|
8 Participants
n=45 Participants
|
26 Participants
n=93 Participants
|
|
Clinical Risk Factors
COPD
|
5 Participants
n=48 Participants
|
5 Participants
n=45 Participants
|
10 Participants
n=93 Participants
|
|
Clinical Risk Factors
Other Lung Disease
|
5 Participants
n=48 Participants
|
5 Participants
n=45 Participants
|
10 Participants
n=93 Participants
|
|
Body Mass Index (BMI)
|
29.6 kg/m^2
STANDARD_DEVIATION 6.9 • n=48 Participants • Participants for whom BMI measurements were recorded at baseline.
|
28.4 kg/m^2
STANDARD_DEVIATION 8.0 • n=44 Participants • Participants for whom BMI measurements were recorded at baseline.
|
29.0 kg/m^2
STANDARD_DEVIATION 7.4 • n=92 Participants • Participants for whom BMI measurements were recorded at baseline.
|
PRIMARY outcome
Timeframe: 90 DaysNumber of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedChange from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Delta (Peak Minus Baseline) Troponin Level
Baseline
|
0.1 ng/mL
Standard Deviation 0.1
|
0.10 ng/mL
Standard Deviation 0.5
|
|
Delta (Peak Minus Baseline) Troponin Level
Peak
|
0.2 ng/mL
Standard Deviation 0.4
|
0.1 ng/mL
Standard Deviation 0.5
|
|
Delta (Peak Minus Baseline) Troponin Level
Delta
|
0.1 ng/mL
Standard Deviation 0.3
|
0 ng/mL
Standard Deviation 0
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedPopulation: Participants with analyzable samples at each timepoint
Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Baseline
|
503 pg/mL
Standard Deviation 765
|
389 pg/mL
Standard Deviation 798
|
|
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Peak
|
611 pg/mL
Standard Deviation 796
|
514 pg/mL
Standard Deviation 817
|
|
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Delta
|
108 pg/mL
Standard Deviation 218
|
134 pg/mL
Standard Deviation 241
|
SECONDARY outcome
Timeframe: Baseline, Day 30Population: no participant was able to receive a repeat echocardiogram at day 30
Number of participants experiencing LVEF of \< 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedPopulation: Participants with analyzable samples at each timepoint
Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Baseline
|
9.9 mg/dL
Standard Deviation 7.3
|
7.2 mg/dL
Standard Deviation 5.7
|
|
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Peak
|
13.6 mg/dL
Standard Deviation 8.9
|
9.8 mg/dL
Standard Deviation 7.8
|
|
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Delta
|
3.9 mg/dL
Standard Deviation 7.2
|
2.6 mg/dL
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalizedPopulation: Participants with analyzable samples at each timepoint
Change from baseline D-Dimer level (Day 1) to maximum level among measures taken during hospitalization and at 30 days. D-Dimer is a small protein fragment present in the blood after a blood clot is degraded by fibrinolysis, so named because it contains two D fragments of the fibrin protein joined by a cross-link.
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
Delta
|
145.5 µg/mL
Standard Deviation 353
|
212 µg/mL
Standard Deviation 604
|
|
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
Baseline
|
493.4 µg/mL
Standard Deviation 854
|
669 µg/mL
Standard Deviation 1101
|
|
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
Peak
|
638.9 µg/mL
Standard Deviation 1112
|
861 µg/mL
Standard Deviation 1564
|
SECONDARY outcome
Timeframe: Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90Population: in the rare event of missing data, patients were excluded from analyses
Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=41 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Composite Event-Free Survival Over Time (Days)
Day 0
|
48 Participants
|
41 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 10
|
40 Participants
|
40 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 20
|
36 Participants
|
38 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 30
|
35 Participants
|
37 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 40
|
35 Participants
|
36 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 50
|
35 Participants
|
36 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 60
|
34 Participants
|
36 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 70
|
34 Participants
|
36 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 80
|
34 Participants
|
36 Participants
|
|
Composite Event-Free Survival Over Time (Days)
Day 90
|
34 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Number of Participants Requiring Mechanical Ventilation
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Number of Participants Requiring Mechanical Circulatory Support (MCS)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 90 daysNumber of participants released and re-admitted to the hospital within 90 days of enrollment
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Re-hospitalization at 90 Days
|
7 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: in the rare event of missing data, patients were excluded from analyses
Outcome measures
| Measure |
Colchicine Plus Current Care
n=48 Participants
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=41 Participants
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
All-cause Mortality
|
8 Participants
|
6 Participants
|
Adverse Events
Colchicine Plus Current Care
Serious events: 0 serious events
Other events: 2 other events
Deaths: 8 deaths
Current Care Alone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 6 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Colchicine Plus Current Care
n=48 participants at risk
Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
Colchicine Tablets: COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
Current care per UCLA treating physicians: Current care
|
Current Care Alone
n=45 participants at risk
Current care per UCLA physicians alone (control arm)
Current care per UCLA treating physicians: Current care
|
|---|---|---|
|
Gastrointestinal disorders
GI discomfort
|
4.2%
2/48 • Number of events 2 • 90 Days
Due to illness of study participants, Adverse Events were recorded as such only if thought to be at least possibly related to study intervention, and not likely due to the primary disease process or its treatment
|
0.00%
0/45 • 90 Days
Due to illness of study participants, Adverse Events were recorded as such only if thought to be at least possibly related to study intervention, and not likely due to the primary disease process or its treatment
|
Additional Information
Reza Ardehali, MD, PhD
University of California Los Angeles
Phone: 310-825-5280
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place