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| Column | Value |
|---|---|
| Trial registration number | NCT04320615 |
|
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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Contact
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
global-roche-genentech-trials@gene.com |
|
Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-03-25 |
|
Recruitment status
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Completed |
|
Study design
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
RCT |
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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 |
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Masking
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
multi-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: - hospitalized with covid-19 pneumonia confirmed per who criteria (including a positive pcr of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest x-ray or ct scan - spo2 </=93% or pao2/fio2 <300 mmhg |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- known severe allergic reactions to tcz or other monoclonal antibodies - active tuberculosis (tb) infection - suspected active bacterial, fungal, viral, or other infection (besides covid-19) - in the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments - have received oral anti-rejection or immunomodulatory drugs (including tcz) with the past 3 months - participating in other drug clinical trials (participation in covid-19 anti-viral trials may be permitted if approved by medical monitor) - pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination - treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational covid-19 antivirals may be permitted if approved by medial monitor) - any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study - alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 10 x upper limit of normal (uln) detected within 24 hours at screening (per local lab) - absolute neutrophil count (anc) < 1000/ml at screening (per local lab) - platelet count < 50,000/ml at screening (per local lab) |
|
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 |
Hoffmann-La Roche |
|
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 |
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Countries
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Canada;Denmark;France;Germany;Italy;Netherlands;Spain;United Kingdom;United States |
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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 |
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Total sample size
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
452 |
|
primary outcome
Last imported at : July 8, 2021, 4 a.m. Source : ClinicalTrials.gov |
Clinical Status Assessed Using a 7-Category Ordinal Scale at Day 28 (Week 4) |
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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 3 |
|
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Results also posted for EUCTR2020-001154-22: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001154-22/results", "treatment_id": 1299, "treatment_name": "Tocilizumab", "treatment_type": "Interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Results also posted for EUCTR2020-001154-22: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001154-22/results", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |