Covid19Phase 1/2Colheart-19NCT04762771
Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19)
A Phase 1/2 study testing Colchicine in people with Covid19, run by Baptist Health South Florida at 1 site in United States.
Trial summary
This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Covid19
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2020to 20 Sep 2021
- Phase
- Phase 1/2
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women ≥ 18 years of age
- Covid-19 Positive
- Hospitalized patients able to provide informed consent
- Cardiac injury (as evidenced by any of the following)
- Elevated troponin level
- Elevated BNP level
- New ischemic or arrhythmogenic ECG/telemetry changes
- New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial effusion on echocardiogram
Who cannot join
- Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
- Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
- Hormone method 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
- History of severe hematologic or neuromuscular disorder
Show all 9Show fewer
- Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor
- Severe renal impairment with concomitant hepatic impairment
- Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or hepatic impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)
This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)
Read the detailed description
We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease.
Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury.
This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
- Conditions
- Covid19
- Being tested
- Colchicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19
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
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | Hospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. Receives: Drug: Colchicine |
| Control | No intervention | Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Composite of all-cause mortality
Measured: 90 days
Mechanical Ventilation
Need for mechanical ventilation
Measured: 90 days
Mechanical Circulatory Support
Need for mechanical circulatory support
Measured: 90 days
Secondary outcomes (7)
Time (Days) to the Primary End Point
Number of days from start of therapy to either mortality or need for Mechanical Ventilation or Mechanical Circulatory Support
Measured: 90 days
Peak and Delta (Change From Baseline) Troponin Level
Change from baseline to the time when Troponin levels peak during the hospitalization
Measured: baseline and 90 days
Baseline Brain Natriuretic Peptide (BNP) Level
Documenting baseline Brain Natriuretic Peptide (BNP) at the time of hospitalization
Measured: baseline
Inflammatory Biomarkers
Baseline and delta (change from baseline) of C-Reactive Protein
Measured: baseline and 90 days
Hospital Length of Stay
Duration of Hospitalization on each arm
Measured: 90 days
Need for Re-hospitalization
90-day re-hospitalization rate
Measured: 90 days
Change in Inflammatory Biomarkers
Baseline and delta (change from baseline) of D-Dimer
Measured: baseline and 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 Feb 2021
- Study start23 Dec 2020
- Primary completion12 May 2021
- Study completion20 Sep 2021
Why it stopped: Recovery Trial showed no convincing evidence that further recruitment would provide conclusive proof of worthwhile benefit for the evaluation of Colchicine in patients with Covid-19.
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 (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Sandra Chaparro, MD, Principal investigator, Baptist Health South FloridaRaul E Herrera, MD, Study director, Baptist Health South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762771
- Sponsor's protocol ID
- 152247
- Acronym
- Colheart-19
- Status last verified
- Jul 2022
- First submitted
- 18 Feb 2021
- Last updated
- 25 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
PubMed 34658014
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm)
- ClinicalTrials.gov ID
- NCT04762771
- Acronym / sponsor ID
- Colheart-19 / 152247
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recovery Trial showed no convincing evidence that further recruitment would provide conclusive proof of worthwhile benefit for the evaluation of Colchicine in patients with Covid-19.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- University of California, Los Angeles
- Study start
- 23 Dec 2020 (actual)
- Primary completion
- 12 May 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Posted 14 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label unblinded, randomized study to treat hospitalized covid-19 patients with colchicine plus current care (per institution treating physicians) vs. current care per institution treating physicians alone (the control arm)
Detailed description
We aim to determine if Colchicine improves short-term outcomes in hospitalized coronavirus disease-19 (COVID-19) patients with cardiac manifestations of disease.
Myocardial injury has been described in up to 30% of COVID-19 infected patients, and portends a poor prognosis with currently no known treatment. Colchicine is a widely available, well-established, inexpensive, oral anti-inflammatory agent that has been FDA approved for the treatment of inflammatory disorders including gout and familial Mediterranean Fever. Trials have also shown its benefit to prevent post-cardiotomy syndrome, to treat acute and recurrent pericarditis, and reduce cardiovascular events after myocardial infarction. We extrapolate based on these indications and studies that colchicine may also help improve outcomes in hospitalized COVID-19 patients with evidence of cardiac injury.
This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an unblinded randomized study to treat hospitalized covid-19 patients with colchicine plus current care per institution treating physicians vs. current care per institution treating physicians alone (the control arm)
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: ColchicineHospitalized covid-19 patients treated with colchicine plus current care per institution treating physicians. |
| Control | No intervention | –Hospitalized covid-19 patients treated with current standard of care (per institution treating physicians) alone. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and Women ≥ 18 years of age
- Covid-19 Positive
- Hospitalized patients able to provide informed consent
- Cardiac injury (as evidenced by any of the following)
Key exclusion criteria (9 listed)
- Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use adequate contraception, which includes:
- History of severe hematologic or neuromuscular disorder
- Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport inhibitor
- Severe renal impairment with concomitant hepatic impairment
- Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or 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 |
|---|---|---|
| ColchicineAlso: Treatment with Colchicine plus standard of care in hospitalized patients with Covid-19Colchicine 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 | Drug | Active |
Primary outcome
Mortality
Time frame: 90 days
Composite of all-cause mortality
Mechanical Ventilation
Time frame: 90 days
Need for mechanical ventilation
Mechanical Circulatory Support
Time frame: 90 days
Need for mechanical circulatory support
7 secondary outcomes
Time (Days) to the Primary End Point
Time frame: 90 days
Peak and Delta (Change From Baseline) Troponin Level
Time frame: baseline and 90 days
Baseline Brain Natriuretic Peptide (BNP) Level
Time frame: baseline
Inflammatory Biomarkers
Time frame: baseline and 90 days
Hospital Length of Stay
Time frame: 90 days
Need for Re-hospitalization
Time frame: 90 days
Change in Inflammatory Biomarkers
Time frame: baseline and 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34658014Mikolajewska A, Fischer AL, Piechotta V, Mueller A, Metzendorf MI, Becker M, Dorando E, Pacheco RL, Martimbianco ALC, Riera R, Skoetz N, Stegemann M. Colchicine for the treatment of COVID-19. Cochrane Database Syst Rev. 2021 Oct 18;10(10):CD015045. doi: 10.1002/14651858.CD015045.
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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.
Sandra Chaparro, MD principal investigator
Baptist Health South Florida
Raul E Herrera, MD study director
Baptist Health South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Colchicine in people with Covid19, run by Baptist Health South Florida at 1 site 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 8 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: stopped early, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 14 Mar 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?
Mortality (time frame: 90 days). The study lists 3 primary outcomes in all. 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 NCT04762771, which also lists 1 linked publication.
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 25 Jul 2022.