Canakinumab in Patients With COVID-19 and Type 2 Diabetes

Sponsor
University Hospital, Basel, Switzerland
Study ID
NCT04510493
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Canakinumab — DRUG
    Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours
  • Placebo — DRUG
    Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours

Study Details

The purpose of this study is to evaluate whether Canakinumab has beneficial effects on patients with Type 2 diabetes mellitus and coronavirus disease 19 (COVID19).

Key Dates

Start date
Oct 23, 2020
Status verified
Sep 2021
Primary completion
Aug 17, 2021
Completion
Aug 17, 2021

Study Design

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

Arms

  • Active Comparator: active treatment arm
    Treatment with Canakinumab i.v. administered over 2 hours
  • Placebo Comparator: placebo treatment arm
    placebo treatment

Primary Outcome Measure

unmatched win ratio after treatment with canakinumab compared to Placebo (composite endpoint) [ Time Frame: within 4 weeks after treatment with canakinumab or placebo ]

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