Trial Outcomes & Findings for Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) (NCT NCT04762771)

Results Overview

Composite of all-cause mortality

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

2 participants

Primary outcome timeframe

90 days

Results posted on

2022-07-25

Participant Flow

The rapid decline in COVID patients and other competing trials did not allowed enrollment of additional subjects. Given the small sample size, the study was terminated.

Patients who test positive for COVID-19, sign informed consent and have any of the study specific manifestations of cardiac injury were randomized 1:1 .

Participant milestones

Participant milestones
Measure	Control - Standard of Care Alone Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.	Active - Colchicine Plus Standard of Care Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral
Overall Study STARTED	1	1
Overall Study COMPLETED	1	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 90 days

Composite of all-cause mortality

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Mortality	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 90 days

Need for mechanical ventilation

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Mechanical Ventilation	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 90 days

Need for mechanical circulatory support

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Mechanical Circulatory Support	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 90 days

Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Time (Days) to the Primary End Point	0 days	0 days

SECONDARY outcome

Timeframe: baseline and 90 days

Change from baseline to the time when Troponin levels peak during the hospitalization

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Peak and Delta (Change From Baseline) Troponin Level Baseline (Peak)	0.16 ng/ml	0.02 ng/ml
Peak and Delta (Change From Baseline) Troponin Level Delta	-0.07 ng/ml	0 ng/ml

SECONDARY outcome

Timeframe: baseline

Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Baseline Brain Natriuretic Peptide (BNP) Level	27 pg/ml	205 pg/ml

SECONDARY outcome

Timeframe: baseline and 90 days

Baseline and delta (change from baseline) of C-Reactive Protein

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Inflammatory Biomarkers Baseline	34.2 mg/l	3.0 mg/l
Inflammatory Biomarkers Delta	19.1 mg/l	-0.1 mg/l

SECONDARY outcome

Timeframe: 90 days

Duration of Hospitalization on each arm

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Hospital Length of Stay	5 days	14 days

SECONDARY outcome

Timeframe: 90 days

90-day re-hospitalization rate

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Need for Re-hospitalization	1 times hospitalized	2 times hospitalized

SECONDARY outcome

Timeframe: baseline and 90 days

Baseline and delta (change from baseline) of D-Dimer

Outcome measures

Outcome measures
Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Change in Inflammatory Biomarkers Baseline	0.46 mcg/ml	0.27 mcg/ml
Change in Inflammatory Biomarkers Delta	19 mcg/ml	0 mcg/ml

Adverse Events

Active

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active n=1 participants at risk Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 participants at risk Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.
Respiratory, thoracic and mediastinal disorders Pneumonia	100.0% 1/1 • Number of events 1 • Adverse event data was collected from baseline through the 90 day follow-up period.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from baseline through the 90 day follow-up period.
Respiratory, thoracic and mediastinal disorders COVID-19	0.00% 0/1 • Adverse event data was collected from baseline through the 90 day follow-up period.	100.0% 1/1 • Number of events 1 • Adverse event data was collected from baseline through the 90 day follow-up period.

Other adverse events

Adverse event data not reported

Additional Information

Raul Herrera, MD (Director Miami Cardiac & Vascular Institute)

baptist health south florida

Phone: 786-596-7609

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Active n=1 Participants Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Colchicine: Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of chronic kidney disease (CKD) stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (aspartate aminotransferase /alanine aminotransferase \> 3x normal). Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral	Control n=1 Participants Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone.	Total n=2 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Non-Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants