NCT04355143

Colchicine to Reduce Cardiac Injury in COVID-19 (COLHEART-19)

Randomized, Open-Label, Controlled Trial of Colchicine to Reduce Cardiac Injury in Hospitalized COVID-19 (Coronavirus Disease 2019) Patients (COLHEART-19)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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). 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

Interventions

Type	Name	Description
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	Current care per UCLA treating physicians	Current care

Timeline

• Start date: 2020-05-01
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2020-04-21
• Last updated: 2022-11-03
• Results posted: 2022-11-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study