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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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 - 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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Random assignment to study arms in a 1:1 ratio
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Colchicine plus current care 		Colchicine 0.6 mg po BID x 30 days plus current care per UCLA treating physicians
  • Drug: 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.
    Other names:
    • COLCRYS
    • AR 374
  • Other: Current care per UCLA treating physicians
    Current care
Active Comparator
Current care alone 		Current care per UCLA physicians alone (control arm)
  • Other: Current care per UCLA treating physicians
    Current care

Recruiting Locations

More Details

NCT ID
NCT04355143
Status
Completed
Sponsor
University of California, Los Angeles

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.