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Monoclonal Antibodies

Clazakizumab for Coronavirus Disease

Phase 2
Waitlist Available
Led By Howard Huang, MD
Research Sponsored by The Methodist Hospital Research Institute
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 60 days
Awards & highlights

Study Summary

This study is evaluating whether a drug may help treat individuals with coronavirus disease.

Eligible Conditions
  • Coronavirus Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 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
Primary Endpoint
Secondary outcome measures
Change in Radiologic Assessment of Lung Edema (RALE) at day 14
Change in Radiologic Assessment of Lung Edema (RALE) at day 28
Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28
+9 more

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: ClazakizumabExperimental Treatment1 Intervention
Clazakizumab - 25mg in 50 milliliters (mL) of 0.9% saline, IV infusion over 30 minutes.
Group II: PlaceboPlacebo Group1 Intervention
Placebo - 50 mL 0.9% saline, IV infusion over 30 minutes.
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?

The Methodist Hospital Research InstituteLead Sponsor
275 Previous Clinical Trials
80,485 Total Patients Enrolled
Howard Huang, MDPrincipal InvestigatorThe Methodist Hospital Research Institute
~12 spots leftby Jun 2025
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