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| Column | Value |
|---|---|
| Trial registration number | NCT04409262 |
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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 : Jan. 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
global-roche-genentech-trials@gene.com |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-06-01 |
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Recruitment status
Last imported at : March 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Completed |
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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 |
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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 |
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Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Oct. 27, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria - hospitalized with covid-19 pneumonia confirmed per a positive polymerase chain reaction (pcr) of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and evidenced by chest x-ray or ct scan - requiring more than 6 l/min supplemental oxygen to maintain spo2 > 93% - agrees to not participate in another clinical trial for the treatment of covid-19 while participating in this study exclusion criteria - known severe allergic reactions to tocilizumab or other monoclonal antibodies - known hypersensitivity to remdesivir, the metabolites, or formulation excipients - 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 - treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months - concurrent treatment with other agents with actual or possible direct-acting antiviral activity against sars-cov-2 within 24 hours prior to study drug dosing. in addition, participants with prior or current treatment with > 2 doses of remdesivir for covid-19 are excluded - participating in other drug clinical trials - estimated glomerular filtration rate (egfr) < 30 ml/min (including patients receiving hemodialysis or hemofiltration) - alanine aminotransferase (alt) or aspartate aminotransferase (ast) > 5 x upper limit of normal (uln) detected within 24 hours of screening (according to local laboratory reference ranges) - absolute neutrophil count (anc) < 1000/ul at screening - platelet count < 50,000/ul at screening - body weight < 40 kg - treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization |
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Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Hoffmann-La Roche |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
12 |
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Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Brazil;Russia;Spain;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 |
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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 : March 13, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
649 |
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primary outcome
Last imported at : Feb. 15, 2022, 4:30 p.m. Source : ClinicalTrials.gov |
Time to Hospital Discharge or "Ready for Discharge" up to Day 28 |
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Notes
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Feb. 25, 2021, 7:58 p.m. Source : ClinicalTrials.gov |
Phase 3 |
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Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1689, "treatment_name": "Remdesivir+tocilizumab", "treatment_type": "Antivirals+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}] |