Canakinumab in Covid-19 Cardiac Injury (The Three C Study)

Part of paid clinical trials in Weston, Florida.

Sponsor
The Cleveland Clinic
Study ID
NCT04365153
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Canakinumab Injection 600mg — DRUG
    Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
  • Canakinumab Injection 300mg — DRUG
    Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients \</= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
  • Placebos — DRUG
    250 mL of 5% dextrose infused IV over 2 hours

Study Details

TThe purpose of this prospective, Phase 2, single center, blinded, randomized controlled study is to demonstrate as a proof of concept that early treatment with canakinumab prevents progressive heart and respiratory failure in patients with COVID-19 infection. These results will lead to and inform a Phase III randomized placebo-controlled trial.

Key Dates

Start date
Apr 24, 2020
Status verified
Apr 2021
Primary completion
Feb 2, 2021
Completion
Apr 1, 2021

Study Design

Enrollment
45 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: High Dose Intervention
    600 mg of canakinumab (8 mg/kg for patients \</= 40 kg)
  • Active Comparator: Low Dose Intervention
    300 mg of canakinumab (4 mg/kg for patients \</= 40 kg)
  • Placebo Comparator: Control
    Placebo

Primary Outcome Measure

Number of Participants With Clinical Improvement at Day 14 [ Time Frame: Up to day 14 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Cleveland Clinic FloridaWestonFlorida33331-
Cleveland ClinicClevelandOhio44195-

Find similar trials in Weston, FL

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Cleveland Clinic Florida· Weston, FLCleveland Clinic· Cleveland, OH

Related Studies