COVID-19Phase 2COLHEART-19NCT04355143
Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)
A Phase 2 study testing Colchicine Tablets and Current care per UCLA treating physicians in people with COVID-19, run by University of California, Los Angeles at 3 sites in United States.
Trial summary
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Colchicine Tablets and Current care per UCLA treating physicians
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2020to 21 Jul 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed COVID-19 infection by polymerase chain reaction
- Cardiac injury, including any of the following:
- Elevated troponin level
- Elevated B-type natriuretic peptide (BNP) level
- New ischemic or arrhythmogenic changes on ECG/telemetry
- New decrease in left ventricular ejection fraction (LVEF) or new pericardial effusion on echocardiogram
- Able to provide informed consent
Who cannot join
- Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:
- Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
- Hormone methods with a barrier method
- Two barrier methods
- If a partner's vasectomy is the chosen method of contraception, a hormone or barrier method must also be used in conjunction
- Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein (P-gp) transport system inhibitors
Show all 9Show fewer
- Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
- Severe hematologic or neuromuscular disorders
- Severe renal impairment with concomitant hepatic impairment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCLA Ronald Reagan Medical Center
Los Angeles, California, 90095
Miami Cardiac and Vascular Institutde, Baptist Health South Florida
Miami, Florida, 33176
UCLA Santa Monica Hospital
Santa Monica, California, 90404
About this study
Official title: Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.
- Conditions
- COVID-19
- Being tested
- Colchicine Tablets, Current care per UCLA treating physicians
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine TabletsDrug
Also called COLCRYS, AR 374
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 physiciansOther
Current care
| Study group | Role | What they receive |
|---|---|---|
| Colchicine plus current care | Experimental | Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians Receives: Drug: Colchicine Tablets; Other: Current care per UCLA treating physicians |
| Current care alone | Active comparator | Current care per UCLA physicians alone (control arm) Receives: Other: Current care per UCLA treating physicians |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
Measured: 90 Days
Secondary outcomes (10)
Delta (Peak Minus Baseline) Troponin Level
Change from initial troponin level to maximum level of troponin among measures taken during hospitalization and at 30 days
Measured: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Change from baseline BNP level (Day 1) to maximum level of BNP among measures taken during hospitalization and at 30 days
Measured: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography
Number of participants experiencing LVEF of < 50% on echocardiogram with failure to show an improvement of ≥ 5% at 30 days
Measured: Baseline, Day 30
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Change from baseline CRP level (Day 1) to maximum level of CRP among measures taken during hospitalization and at 30 days
Measured: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
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.
Measured: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Composite Event-Free Survival Over Time (Days)
Participants reaching primary (composite) endpoint were subtracted from event-free survival reported at 10-day intervals
Measured: Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90
Number of Participants Requiring Mechanical Ventilation
Measured: 90 days
Number of Participants Requiring Mechanical Circulatory Support (MCS)
Measured: 90 days
Re-hospitalization at 90 Days
Number of participants released and re-admitted to the hospital within 90 days of enrollment
Measured: 90 days
All-cause Mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 May 2020
- Primary completion21 Jul 2021
- Study completion21 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random assignment to study arms in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Ardehali, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355143
- Sponsor's protocol ID
- 20-000685
- Acronym
- COLHEART-19
- Status last verified
- Nov 2022
- First submitted
- 14 Apr 2020
- Last updated
- 3 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rabbani A, Rafique A, Wang X, Campbell D, Wang D, Brownell N, Capdevilla K, Garabedian V, Chaparro S, Herrera R, Parikh RV, Ardehali R. Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With Coronavirus Disease-19. Front Cardiovasc Med. 2022 Jun 17;9:876718. doi: 10.3389/fcvm.2022.876718. eCollection 2022.
PubMed 35783822Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
PubMed 34473343
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)
- ClinicalTrials.gov ID
- NCT04355143
- Acronym / sponsor ID
- COLHEART-19 / 20-000685
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 21 Jul 2021 (actual)
- First posted
- 21 Apr 2020 (actual)
- Results
- Posted 3 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will be randomized in a 1:1 ratio to receive Colchicine plus current care per UCLA treating physicians versus current care per UCLA treating physicians alone (control arm). Importantly, this adaptive trial design allows for patients in either study arm to receive other investigational drugs for COVID-19 as new science emerges.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Random assignment to study arms in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Colchicine plus current care | Experimental | Drug: Colchicine Tablets, Other: Current care per UCLA treating physiciansColchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians |
| Current care alone | Active comparator | Other: Current care per UCLA treating physiciansCurrent care per UCLA physicians alone (control arm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Confirmed COVID-19 infection by polymerase chain reaction
- Cardiac injury, including any of the following:
- Able to provide informed consent
Key exclusion criteria (9 listed)
- Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use 2 forms of contraception, which includes:
- Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein (P-gp) transport system inhibitors
- Concurrent use of strong CYP3A4 or P-gp inhibitors in patients with renal or hepatic impairment;
- Severe hematologic or neuromuscular disorders
- Severe renal impairment with concomitant hepatic impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine TabletsAlso: COLCRYS, AR 374COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days. | Drug | Colchicine plus current care |
| Current care per UCLA treating physiciansCurrent care | Other | Colchicine plus current care, Current care alone |
Primary outcome
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS)
Time frame: 90 Days
Number of participants experiencing any of the following: All-cause mortality, need for mechanical ventilation, or need for mechanical circulatory support (MCS)
10 secondary outcomes
Delta (Peak Minus Baseline) Troponin Level
Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Delta (Baseline to Peak) Brain Natriuretic Peptide (BNP) Level
Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Change in Left Ventricular Ejection Fraction (LVEF) on Echocardiography
Time frame: Baseline, Day 30
Delta (Peak Minus Baseline) C-Reactive Protein (CRP) Inflammatory Biomarker Level
Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Delta (Peak Minus Baseline) D-Dimer Inflammatory Biomarker Level
Time frame: Baseline (Day 1), Day 30, Days 3 and 7 if hospitalized
Composite Event-Free Survival Over Time (Days)
Time frame: Days 0, 10, 20, 30, 40, 50, 60, 70, 80, and 90
Number of Participants Requiring Mechanical Ventilation
Time frame: 90 days
Number of Participants Requiring Mechanical Circulatory Support (MCS)
Time frame: 90 days
Re-hospitalization at 90 Days
Time frame: 90 days
All-cause Mortality
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35783822Rabbani A, Rafique A, Wang X, Campbell D, Wang D, Brownell N, Capdevilla K, Garabedian V, Chaparro S, Herrera R, Parikh RV, Ardehali R. Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With Coronavirus Disease-19. Front Cardiovasc Med. 2022 Jun 17;9:876718. doi: 10.3389/fcvm.2022.876718. eCollection 2022.
- Derived from this study: PubMed 34473343Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
RecruitingObservational study
Cardiovascular Disease Progression in Survivors of Community Acquired Pneumonia and Lung Infection by Covid-19.
Pneumonia, Community-Acquired, COVID-19 Pneumonia
RecruitingPhase 3
A Clinical Study of Molnupiravir to Prevent Severe Illness From Coronavirus Disease 2019 (COVID-19) in People Who Are High Risk (MK-4482-023)
Coronavirus Disease (COVID-19)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reza Ardehali, MD, PhD principal investigator
University of California, Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine Tablets and Current care per UCLA treating physicians in people with COVID-19, run by University of California, Los Angeles at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of All-cause Mortality, Need for Mechanical Ventilation, or Need for Mechanical Circulatory Support (MCS) (time frame: 90 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04355143, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.