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Monoclonal Antibodies
Use of the Interleukin-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
Phase 2
Recruiting
Led By Nada Alachkar, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 days
Summary
This trial will test if the drug clazakizumab can help treat patients with severe COVID-19. 30 patients will be given the drug or a placebo and researchers will compare the results.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in C-reactive protein (CRP) level
Side effects data
From 2015 Phase 2 trial • 143 Patients • NCT020155205%
FATIGUE
5%
INJECTION SITE BRUISING
5%
HYPERCHOLESTEROLAEMIA
5%
INJECTION SITE RASH
5%
COUGH
5%
HYPERURICAEMIA
5%
INFLUENZA LIKE ILLNESS
5%
URINARY TRACT INFECTION
5%
BRONCHITIS
5%
CONTUSION
5%
HYPERTRIGLYCERIDAEMIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Methotrexate (MTX)
Clazakizumab (1 mg) + MTX
Clazakizumab (5 mg) + MTX
Clazakizumab (25 mg) + MTX
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: clazakizumab at a dose of 25 mgExperimental Treatment1 Intervention
A first dose of 25 mg of clazakizumab will be given. No premedications will be given prior to the investigational product. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25mg clazakizumab (an identical dose to the day 1 dose) will be given no later than day 3
Group II: placeboPlacebo Group1 Intervention
A first dose of placebo will be given. No premedications will be given prior to the investigational product. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo (an identical dose to the day 1 dose) will be given no later than day 3
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Clazakizumab
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,332 Previous Clinical Trials
14,874,870 Total Patients Enrolled
Nada Alachkar, MDPrincipal InvestigatorJohns Hopkins University