A study to look at the safety and success of using Clazakizumab in patients who have kidney disease and COVID-19.

A study to assess the safety and efficacy of Clazakizumab in patients with COVID-19 and kidney disease. - CLiCK Study

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002476-13-GB

Enrollment

Registered

2020-06-29

Start date

2020-07-24

Completion date

Unknown

Last updated

2020-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with kidney disease who are hospitalised with COVID-19 infection with pulmonary involvement (i.e. consistent chest imaging abnormalities) and clinical deterioration (i.e increasing oxygen requirements or biochemical signs of hyperinflammation). MedDRA version: 20.0 Level: LLT Classification code 10023417 Term: Kidney dysfunction System Organ Class: 100000004857 MedDRA version: 20.0 Level: LLT Classification code 10047463 Term: Viral infection NOS System Organ Class: 100000004862 MedD

Interventions

Trade Name: Clazakizumab Product Name: Clazakizumab Product Code: N/A Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: Clazakizumab Other descriptive name: anti-interleukin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Hospitalised with COVID-19 infection with pulmonary involvement (i.e. consistent chest imaging abnormalities). 2. COVID-19 infection defined by as per WHO criteria (including a positive PCR of any specimen e.g., respiratory, blood, urine, stool, other bodily fluid) or detectable IgM antibody 3. Clinical deterioration following admission to hospital defined as increasing oxygen requirement and clinical signs of hyper-inflammation (raised ferritin, d-dimer, CRP) 4. >18 years of age 5. Able to give consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: 1. Unable to provide informed consent 2. Known severe allergic reactions to Clazakizumab 3. Active tuberculosis (TB) infection 4. Suspected active bacterial, fungal, viral, or other infection (besides COVID-19), which in the investigator’s opinion, precludes the patient's safe participation in and completion of the study. 5. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening or at baseline 6. Absolute neutrophil count (ANC) < 1000/mL at screening and baseline 7. Platelet count < 50,000/mL at screening and baseline 8. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination 9. Patients with inflammatory bowel disease (except fully excised ulcerative colitis), diverticular disease (unless fully excised), or history of GI perforation 10. Able to participate in other COVID19 drug clinical trials (participation in COVID19 antiviral trials may be permitted)

Design outcomes

Primary

Measure	Time frame
Main Objective: Is the drug Clazakizumab effective in treating patients with severe COVID-19 infection?;Secondary Objective: To assess the safety of Clazakizumab in treating patients with COVID-19 infection To assess the mechanistic rationale for IL6 blockade in patients who are immunosuppressed and/or have end stage kidney disease ;Primary end point(s): The primary outcome measure is hospital discharge up to day 28. ;Timepoint(s) of evaluation of this end point: Following administration of Clazakizumab, follow-up information about the patient will be collected every two days for the first two weeks (or until discharge or death) and then at 1 and 3 months. Patients discharged will be reviewed at 1 and 3 months.	—

Measure

Time frame

Main Objective: Is the drug Clazakizumab effective in treating patients with severe COVID-19 infection?;Secondary Objective: To assess the safety of Clazakizumab in treating patients with COVID-19 infection To assess the mechanistic rationale for IL6 blockade in patients who are immunosuppressed and/or have end stage kidney disease ;Primary end point(s): The primary outcome measure is hospital discharge up to day 28. ;Timepoint(s) of evaluation of this end point: Following administration of Clazakizumab, follow-up information about the patient will be collected every two days for the first two weeks (or until discharge or death) and then at 1 and 3 months. Patients discharged will be reviewed at 1 and 3 months.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary outcome measures are as follows and will all be measured within 28 days post administration: • Time to Clinical Improvement (national early warning score 2 (NEWS) of =2 maintained for 24 hours) • Incidence of mechanical ventilation • Incidence of non-invasive ventilation • Incidence of Intensive Care admission • Duration of Intensive Care admission • Duration of time on supplemental oxygen • Mortality Rate • Participants with adverse events • Change from baseline of inflammatory markers (including Ferritin, Lactate dehydrogenase, D-Dimer, C-Reactive Protein, IL-6 and other cytokines), measured at least twice during the first 2 weeks post administration ;Timepoint(s) of evaluation of this end point: The following information will be collected every 2 days for the first 2 weeks post treatment administration (or until discharge or death). Outcome status (alive/dead), hospitalisation status (inpatient/discharge), use of ventilation and use of new renal replacement therapy will also be collected at the time of death or discharge or at 28 days after treatment (whichever is sooner).	—

Measure

Time frame

Secondary end point(s): The secondary outcome measures are as follows and will all be measured within 28 days post administration: • Time to Clinical Improvement (national early warning score 2 (NEWS) of =2 maintained for 24 hours) • Incidence of mechanical ventilation • Incidence of non-invasive ventilation • Incidence of Intensive Care admission • Duration of Intensive Care admission • Duration of time on supplemental oxygen • Mortality Rate • Participants with adverse events • Change from baseline of inflammatory markers (including Ferritin, Lactate dehydrogenase, D-Dimer, C-Reactive Protein, IL-6 and other cytokines), measured at least twice during the first 2 weeks post administration ;Timepoint(s) of evaluation of this end point: The following information will be collected every 2 days for the first 2 weeks post treatment administration (or until discharge or death). Outcome status (alive/dead), hospitalisation status (inpatient/discharge), use of ventilation and use of new renal replacement therapy will also be collected at the time of death or discharge or at 28 days after treatment (whichever is sooner).

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026