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| Column | Value |
|---|---|
| Trial registration number | NCT04494724 |
|
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 |
iagboli@houstonmethodist.org |
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Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2020-07-31 |
|
Recruitment status
Last imported at : July 18, 2022, 11:30 a.m. Source : ClinicalTrials.gov |
Unknown |
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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 |
single-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 : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: age >18 at the time of screening. participant or legally authorized representative (lar) must be able to understand and provide informed consent. hospitalized with coronavirus disease (covid-19) confirmed by polymerase chain reaction (pcr) assay from any specimen (eg, respiratory, blood, urine, stool, other bodily fluid) within the prior 72 hours. c-reactive protein (crp) > 3.5 mg/dl evidence of pulmonary involvement with at least 2 of the following: oxygen saturation at rest in ambient air with peripheral capillary oxygen saturation (spo2) ≤ 94% tachypnea with resting respiration rate > 25 breaths/minute partial pressure of oxygen (pao2)/initial fraction of inspired oxygen (fio2) ≤ 300 mmhg chest imaging (radiograph, ct, or ultrasound) with abnormalities consistent covid-19 pneumonia |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
previous hypersensitivity or allergic reactions to clazakizumab lactating or pregnant females patients with latent tuberculosis (tb) and who are not receiving treatment patients with active tb patients with known active inflammatory bowel disease, untreated diverticulitis, or gastrointestinal perforation requiring mechanical ventilation or extracorporeal membrane oxygenation (ecmo) a significantly abnormal general serum screening lab result defined as a white blood cell (wbc) count < 3.0 x 10^3/ml, a hemoglobin (hgb) < 8.0 g/dl, a platelet count < 50 x 10^3/ml, an aspartate aminotransferase (ast) or alanine aminotransferase (alt) > 5 times upper limit normal participation in another clinical trial investigating covid-19-aimed agents presence of any medical or psychosocial condition, which the investigator believes, would hinder adherence to the study requirements. |
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Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
2 |
|
Funding
Last imported at : Sept. 7, 2021, 2 a.m. Source : ClinicalTrials.gov |
The Methodist Hospital Research Institute |
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Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
18 |
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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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
United States |
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Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
|
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
60 |
|
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Primary Endpoint |
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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 2 |
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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"}] |