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| Column | Value |
|---|---|
| Trial registration number | NCT04780321 |
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Full text link
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
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First author
Last imported at : July 19, 2022, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : July 19, 2022, noon Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2021-03-03 |
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Recruitment status
Last imported at : July 19, 2022, noon Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Sequential assignment |
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Masking
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : March 5, 2021, 12:31 a.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 of 18-65 years (inclusive) ,women or man sars-cov-2 detected in the diagnostic specimen (nasopharyngeal swab) high homology of viral gene sequencing with the known sars-cov-2." mild/moderateillness covid-19 or sars-cov-2 asymptomatic infection within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of sars-cov-2 positive test to randomization with required viral load no plan of pregnancy and being willing to use effective contraceptive measures signed the informed consent form, sufficiently understanding of the content |
|
Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m. Source : ClinicalTrials.gov |
positive igm/igg against sars-cov-2 prior to randomization. severeor critical illness uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases history of sars-cov-2 vaccination or participation in clinical trial with neutralizing antibody against sars-cov-2. use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing platelets and hemoglobin test results during screening period are abnormal and have clinical significanc. anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others |
|
Number of arms
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Shanghai Junshi Bioscience Co., Ltd. |
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Inclusion age min
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : July 19, 2022, noon Source : ClinicalTrials.gov |
62 |
|
primary outcome
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples);Safety Measurements : 90 of participants with treatment-related adverse events as assessed byCTCAE v5.0 |
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Notes
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
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Arms
Last imported at : March 5, 2021, 12:31 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "25mg/kg", "treatment_id": 484, "treatment_name": "Etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "50mg/kg", "treatment_id": 484, "treatment_name": "Etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "100mg/kg", "treatment_id": 484, "treatment_name": "Etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |