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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
8%
LEUKOPENIA
8%
INJECTION SITE REACTION
8%
NEUTROPENIA
5%
DYSLIPIDAEMIA
5%
ALANINE AMINOTRANSFERASE INCREASED
3%
TOOTH INFECTION
3%
ABDOMINAL PAIN
3%
DENTAL CARIES
3%
IRRITABLE BOWEL SYNDROME
3%
VIRAL INFECTION
3%
LABYRINTHITIS
3%
NASOPHARYNGITIS
3%
BRONCHITIS
3%
UPPER RESPIRATORY TRACT INFECTION
3%
DIZZINESS
3%
GASTROENTERITIS VIRAL
3%
HERPES ZOSTER
3%
SKIN CANDIDA
3%
JOINT INJURY
3%
LACERATION
3%
DIABETES MELLITUS
3%
TENSION HEADACHE
3%
EOSINOPHILIA
3%
THROMBOCYTOPENIA
3%
RASH VESICULAR
3%
HEPATIC STEATOSIS
3%
EAR PAIN
3%
TINNITUS
3%
INJECTION SITE ERYTHEMA
3%
INJECTION SITE PRURITUS
3%
STOMATITIS
3%
BLOOD CHOLESTEROL INCREASED
3%
RHINITIS ALLERGIC
3%
THROAT IRRITATION
3%
HEPATIC FUNCTION ABNORMAL
3%
VULVOVAGINAL DISCOMFORT
3%
INJECTION SITE VESICLES
3%
INJECTION SITE RASH
3%
HEPATIC ENZYME INCREASED
3%
URINARY TRACT INFECTION
3%
LIMB INJURY
3%
SKIN HYPERPIGMENTATION
100%
80%
60%
40%
20%
0%
Study treatment Arm
Clazakizumab (25 mg) + MTX
Clazakizumab (1 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
274 Previous Clinical Trials
80,475 Total Patients Enrolled
Howard Huang, MDPrincipal InvestigatorThe Methodist Hospital Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The LancetJournal
COVID-19: Consider Cytokine Storm Syndromes and Immunosuppression
Mehta, Puja, Daniel F McAuley, Michael Brown, Emilie Sanchez, Rachel S Tattersall, and Jessica J Manson. 2020. “COVID-19: Consider Cytokine Storm Syndromes and Immunosuppression”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(20)30628-0.
JAMA Internal MedicineJournal
Risk Factors Associated with Acute Respiratory Distress Syndrome and Death in Patients with Coronavirus Disease 2019 Pneumonia in Wuhan, China
Wu, Chaomin, Xiaoyan Chen, Yanping Cai, Jia’an Xia, Xing Zhou, Sha Xu, Hanping Huang, et al.. 2020. “Risk Factors Associated with Acute Respiratory Distress Syndrome and Death in Patients with Coronavirus Disease 2019 Pneumonia in Wuhan, China”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2020.0994.
Intensive Care MedicineJournal
Correction To: Clinical Predictors of Mortality Due to COVID-19 Based on an Analysis of Data of 150 Patients from Wuhan, China
Ruan, Qiurong, Kun Yang, Wenxia Wang, Lingyu Jiang, and Jianxin Song. 2020. “Correction To: Clinical Predictors of Mortality Due to COVID-19 Based on an Analysis of Data of 150 Patients from Wuhan, China”. Intensive Care Medicine. Springer Science and Business Media LLC. doi:10.1007/s00134-020-06028-z.
The LancetJournal
COVID-19: Consider Cytokine Storm Syndromes and Immunosuppression
Mehta, Puja, Daniel F McAuley, Michael Brown, Emilie Sanchez, Rachel S Tattersall, and Jessica J Manson. 2020. “COVID-19: Consider Cytokine Storm Syndromes and Immunosuppression”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(20)30628-0.
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~13 spots leftby May 2025
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