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Trial - NCT04377659


Column Value
Trial registration number NCT04377659
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04377659

First author
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

Boglarka Gyurkocza

Contact
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

gyurkocb@mskcc.org

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

2020-05-06

Recruitment status
Last imported at : Nov. 4, 2022, 8 a.m.
Source : ClinicalTrials.gov

Terminated

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

Open 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 : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - patient or designated proxy willing and able to provide informed consent prior to enrollment in the study. - covid-19 pcr positive on nasopharyngeal swab - aged >/= 18 years old - patient hospitalized with newly diagnosed documented severe covid-19 infection: with respiratory rate >/= 30 breaths/min or peripheral capillary oxygen saturation (spo2) < 93% on room air for nonintubated pts. - fever of 38.5 c or suspected respiratory infection - il-6 level >/= 80 pcg/ml - cohort #1 - non intubated cohort #2 - intubated - women of childbearing potential must have a negative serum or urine pregnancy test - patients receiving ongoing steroid therapy are eligible - patients will be allowed to receive concurrent or sequential treatment with remdesivir

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

- patients with uncontrolled systemic fungal and bacterial infections - patients with latent tuberculosis - patients with known hypersensitivity to tocilizumab or any component of the formulation - concurrent initiation of steroid therapy is not allowed - patients with uncrontroled malignant disease, with a life expectancy of 3 months or less

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

Memorial Sloan Kettering Cancer 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

None

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/critical disease at enrollment

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

7: Severe/critical disease at enrollment

Total sample size
Last imported at : Dec. 1, 2020, 12:40 p.m.
Source : ClinicalTrials.gov

9

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

Progression of respiratory failure or death

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": "Cohort 1: non intubated; Progression of respiratory failure will be defined as a sustained increase in oxygen requirement or need for intubation/mechanical ventilation", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Cohort 2: intubated; Progression of respiratory failure will be defined as a need for increasing respiratory support (e.g. FiO2 or PEEP)", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]