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

Phase 1

• 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: 20.0Level: LLTClassification code 10023417Term: Kidney dysfunctionSystem Organ Class: 100000004857; MedDRA version: 20.0Level: LLTClassification code 10047463Term: Viral infection NOSSystem Organ Class: 100000004862; MedDRA version: 20.0Level: PTClassification code 10063321Term: Interleukin levelSystem Organ Class: 10022891 - Investigations; MedDRA version: 20.1Level: PTClassification code 10079637Term: Dependence on oxygen therapySystem Organ Class: 10041244 - Social circumstances; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-002476-13-GB
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-06-29
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified