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Monoclonal Antibodies

clazakizumab at a dose of 25 mg for Coronavirus

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
1. At least 18 years of age
2. Confirmed COVID-19 disease (by Cobas Severe Acute Respiratory Syndrome (SARS)-CoV-2 real time RT-PCR using nasopharyngeal swab sample, or equivalent test available to be performed by the Johns Hopkins Medical Laboratories Services). Effort will be made to have the confirmatory test result <72 hours prior to enrollment however given overall clinical demand this may not be feasible in all cases.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 days
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in C-reactive protein (CRP) level

Side effects data

From 2015 Phase 2 trial • 143 Patients • NCT02015520
5%
HYPERURICAEMIA
5%
BRONCHITIS
5%
INJECTION SITE RASH
5%
HYPERTRIGLYCERIDAEMIA
5%
COUGH
5%
INJECTION SITE BRUISING
5%
INFLUENZA LIKE ILLNESS
5%
CONTUSION
5%
FATIGUE
5%
URINARY TRACT INFECTION
5%
HYPERCHOLESTEROLAEMIA
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clazakizumab (1 mg) + MTX
Clazakizumab (25 mg) + MTX
Clazakizumab (5 mg) + MTX
Placebo + Methotrexate (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
2,244 Previous Clinical Trials
14,816,212 Total Patients Enrolled
Nada Alachkar, MDPrincipal InvestigatorJohns Hopkins University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Mar 2025