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Clazakizumab vs. Placebo - COVID-19 Infection

NCT ID: NCT04494724

Last Updated: 2020-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-13

Study Completion Date

2021-07-31

Brief Summary

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The purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.

Detailed Description

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The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the safety and efficacy of clazakizumab vs placebo for the prevention of acute respiratory distress syndrome (ARDS) in patients with COVID-19 and pulmonary manifestations. The study will compare clazakizumab to placebo in a randomized, double-blind fashion followed by an open-label dose of clazakizumab if there is no improvement or a worsening of condition occurs after 24-hours or anytime during the first 14 days after the first dose of clazakizumab or placebo. We hypothesize that clazakizumab will be safely tolerated and will reduce the risk of progression of COVID-19 to acute respiratory distress syndrome.

Primary Objective:

• To evaluate the safety and tolerability of clazakizumab vs placebo for the treatment of patients with COVID-19 disease and signs of pulmonary involvement

Sixty adult patients with COVID-19 and signs of pulmonary involvement at Houston Methodist who are not in need of ventilator support at the time of enrollment.

Conditions

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COVID-19 Infection

Keywords

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COVID-19 coronavirus infection respiration, artificial extracorporeal membrane oxygenation randomized controlled trial respiratory distress syndrome, adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This single-site, phase 2 randomized, double-blind, placebo-controlled trial is designed to administer a single dose of clazakizumab or placebo on day 0. If, after 24 hours or up to 14 days from the first infusion, the participant's condition worsens or does not improve, the investigator may elect to provide a single, open-label dose of clazakizumab regardless of the initial group assignment. All except the investigational pharmacist will remain blinded as to the initial group assignment until data lock.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Blinded to all except investigational pharmacy. Only the optional second infusion, if determined necessary to administer, will be open-label. The patient and study team will remain blinded until data lock at the end of the study.

Study Groups

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Clazakizumab

Clazakizumab - 25mg in 50 milliliters (mL) of 0.9% saline, IV infusion over 30 minutes.

Group Type EXPERIMENTAL

Clazakizumab

Intervention Type DRUG

Infusion

Placebo

Placebo - 50 mL 0.9% saline, IV infusion over 30 minutes.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Infusion

Interventions

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Clazakizumab

Infusion

Intervention Type DRUG

Placebo

Infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 at the time of screening.
2. Participant or legally authorized representative (LAR) must be able to understand and provide informed consent.
3. Hospitalized with coronavirus disease (COVID-19) confirmed by polymerase chain reaction (PCR) assay from any specimen (eg, respiratory, blood, urine, stool, other bodily fluid) within the prior 72 hours.
4. C-reactive protein (CRP) \> 3.5 mg/dL
5. Evidence of pulmonary involvement with at least 2 of the following:

1. oxygen saturation at rest in ambient air with peripheral capillary oxygen saturation (SpO2) ≤ 94%
2. tachypnea with resting respiration rate \> 25 breaths/minute
3. Partial pressure of oxygen (PaO2)/initial fraction of inspired oxygen (FiO2) ≤ 300 mmHg
4. Chest imaging (radiograph, CT, or ultrasound) with abnormalities consistent COVID-19 pneumonia

Exclusion Criteria

1. Previous hypersensitivity or allergic reactions to clazakizumab
2. Lactating or pregnant females
3. Patients with latent tuberculosis (TB) and who are not receiving treatment
4. Patients with active TB
5. Patients with known active inflammatory bowel disease, untreated diverticulitis, or gastrointestinal perforation
6. Requiring mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
7. A significantly abnormal general serum screening lab result defined as a white blood cell (WBC) count \< 3.0 X 10\^3/mL, a hemoglobin (Hgb) \< 8.0 g/dL, a platelet count \< 50 X 10\^3/mL, an aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 5 times upper limit normal
8. Participation in another clinical trial investigating COVID-19-aimed agents
9. Presence of any medical or psychosocial condition, which the investigator believes, would hinder adherence to the study requirements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Howard Huang, MD

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

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Houston Methodist Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Isioma Agboli, MD

Role: CONTACT

Phone: 713-441-6311

Email: [email protected]

Darrel Cleere, BSN

Role: CONTACT

Phone: 713-441-6232

Email: [email protected]

Facility Contacts

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Isioma Agboli, MD

Role: primary

Darrel Cleere, BSN

Role: backup

References

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Jones SA, Jenkins BJ. Recent insights into targeting the IL-6 cytokine family in inflammatory diseases and cancer. Nat Rev Immunol. 2018 Dec;18(12):773-789. doi: 10.1038/s41577-018-0066-7.

Reference Type RESULT
PMID: 30254251 (View on PubMed)

Tanaka T, Kishimoto T. Targeting interleukin-6: all the way to treat autoimmune and inflammatory diseases. Int J Biol Sci. 2012;8(9):1227-36. doi: 10.7150/ijbs.4666. Epub 2012 Oct 24.

Reference Type RESULT
PMID: 23136551 (View on PubMed)

Uciechowski P, Dempke WCM. Interleukin-6: A Masterplayer in the Cytokine Network. Oncology. 2020;98(3):131-137. doi: 10.1159/000505099. Epub 2020 Jan 20.

Reference Type RESULT
PMID: 31958792 (View on PubMed)

Ruan Q, Yang K, Wang W, Jiang L, Song J. Correction to: Clinical predictors of mortality due to COVID-19 based on an analysis of data of 150 patients from Wuhan, China. Intensive Care Med. 2020 Jun;46(6):1294-1297. doi: 10.1007/s00134-020-06028-z.

Reference Type RESULT
PMID: 32253449 (View on PubMed)

Gao Y, Li T, Han M, Li X, Wu D, Xu Y, Zhu Y, Liu Y, Wang X, Wang L. Diagnostic utility of clinical laboratory data determinations for patients with the severe COVID-19. J Med Virol. 2020 Jul;92(7):791-796. doi: 10.1002/jmv.25770. Epub 2020 Apr 10.

Reference Type RESULT
PMID: 32181911 (View on PubMed)

Le RQ, Li L, Yuan W, Shord SS, Nie L, Habtemariam BA, Przepiorka D, Farrell AT, Pazdur R. FDA Approval Summary: Tocilizumab for Treatment of Chimeric Antigen Receptor T Cell-Induced Severe or Life-Threatening Cytokine Release Syndrome. Oncologist. 2018 Aug;23(8):943-947. doi: 10.1634/theoncologist.2018-0028. Epub 2018 Apr 5.

Reference Type RESULT
PMID: 29622697 (View on PubMed)

Mehta P, McAuley DF, Brown M, Sanchez E, Tattersall RS, Manson JJ; HLH Across Speciality Collaboration, UK. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet. 2020 Mar 28;395(10229):1033-1034. doi: 10.1016/S0140-6736(20)30628-0. Epub 2020 Mar 16. No abstract available.

Reference Type RESULT
PMID: 32192578 (View on PubMed)

Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, Huang H, Zhang L, Zhou X, Du C, Zhang Y, Song J, Wang S, Chao Y, Yang Z, Xu J, Zhou X, Chen D, Xiong W, Xu L, Zhou F, Jiang J, Bai C, Zheng J, Song Y. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020 Jul 1;180(7):934-943. doi: 10.1001/jamainternmed.2020.0994.

Reference Type RESULT
PMID: 32167524 (View on PubMed)

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Reference Type DERIVED
PMID: 34473343 (View on PubMed)

Other Identifiers

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Pro00025969

Identifier Type: -

Identifier Source: org_study_id