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Trial - NCT04348500


Column Value
Trial registration number NCT04348500
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04348500

First author
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Noriko Ammerman, PharmD

Contact
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

noriko.ammerman@cshs.org

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-04-16

Recruitment status
Last imported at : Dec. 3, 2021, 11:30 p.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Dec. 3, 2021, 11:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: age >18 at the time of screening subject must be able to understand and provide informed consent hospitalized with covid-19 (+) disease (confirmed by polymerase chain reaction (pcr) assay from any specimen (e.g. respiratory, blood, urine, stool, other bodily fluid)) not on mechanical ventilation and/or ecmo evidence of pulmonary involvement with at least 2 of the following: oxygen saturation (spo2) at rest in ambient air with spo2 ≤ 94% tachypnea with resting respiration rate > 25 breaths/minute partial pressure of oxygen (pao2) / fraction of inspired oxygen (fio2) ≤ 300 mmhg chest imaging (radiograph, ct scan, or lung ultrasound) with abnormalities consistent covid-19 pneumonia c-reactive protein (crp) >35 mg/l

Exclusion criteria
Last imported at : Dec. 3, 2021, 11:30 p.m.
Source : ClinicalTrials.gov

previous hypersensitivity or allergic reactions to clazakizumab lactating or pregnant females subjects with latent tuberculosis (tb) and who are not receiving treatment subjects with active tb a significantly abnormal general serum screening lab result defined as a white blood count (wbc) < 3.0 x 103/ml, a hgb < 8.0 g/dl, a platelet count < 50 x 103/ml, a serum glutamic oxaloacetic transaminase (sgot) or serum glutamic pyruvic transaminase (sgpt) > 5x upper limit normal participation in another clinical trial investigating covid-19 aimed agents

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Cedars-Sinai Medical Center

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

17

primary outcome
Last imported at : Dec. 3, 2021, 11:30 p.m.
Source : ClinicalTrials.gov

Safety of Clazakizumab for the Treatment of Patients With COVID-19 Disease

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 293, "treatment_name": "Clazakizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]