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| Column | Value |
|---|---|
| Trial registration number | NCT05113784 |
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Full text link
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
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First author
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
shihongwei@pmbp.cn |
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Registration date
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
2021-11-09 |
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Recruitment status
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
Recruiting |
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Study design
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Treatment |
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Inclusion criteria
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - 18 years ≤subject ≤ 75 years, male and/or female; - clinical confirmation of covid-19 patients in accordance with novel coronavirus diagnosis and treatment protocol (trial version 8) of the nhc - participants must be able to understand and willing to participate in this research, this study and signed informed consent form (if incapacitated subjects, the researchers believe the subjects to the test in its own interests, should be signed by its legal guardian informed consent, or telephone inform consent (recording) and note it in the original medical records and other relevant documents) |
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Exclusion criteria
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
- subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent; - sars-cov-2 infection by pcr ≥ 96h; - platelet (plt) < 50×10^9/l, or hemoglobin (hgb) < 60g/l; - total bilirubin (tbil) > 2×uln (upper limit of normal value), or alanine transferase (alt), aspartate transferase (ast), alkaline phosphatase (alp) > 5×uln; - glomerular filtration rate (gfr) < 30ml/min·1.73m^2, or serum creatinine increased by 0.5mg/ dl within 7 days, or oliguria (<400ml/24hr), or anuria (<100ml/24hr); - pregnant or breast feeding; - persons who have family planning or do not agree to use effective non-drug contraceptive measures within 6 months after signing the icf; - subjects participating in another clinical study. there will be a need for washout with 5 half lives depending on the study treatment or 30 days since any previous study, whichever is longer; - he inestigators concluded that the patients had other reasons for not being eligible for the study. |
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Number of arms
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
2 |
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Funding
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd |
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Inclusion age min
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
75 |
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Countries
Last imported at : March 20, 2022, 9:56 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Moderate/severe disease at enrollment |
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Severity scale
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
4: Moderate/severe disease at enrollment |
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Total sample size
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
150 |
|
primary outcome
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Time of virus nucleic acid test turning negative |
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Notes
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
Phase 2/Phase 3 |
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Arms
Last imported at : Nov. 11, 2021, 4:30 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 783, "treatment_name": "Meplazumab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |