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| Column | Value |
|---|---|
| Trial registration number | NCT05172141 |
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Full text link
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
|
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First author
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
2021-12-29 |
|
Recruitment status
Last imported at : March 3, 2023, noon Source : ClinicalTrials.gov |
Terminated |
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Study design
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
RCT |
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Allocation
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Randomized |
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Design
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Blind label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Treatment |
|
Inclusion criteria
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
main inclusion criteria: first onset of covid-19 symptoms <7 days at randomization, symptoms such as fever and/or chills, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea. have a positive sars-cov-2 reverse transcription-polymerase chain reaction (rt-pcr) test using an appropriate sample such as nasopharyngeal (np), nasal, oropharyngeal, or saliva within 72 hours prior to randomization. a historical record of a positive result from a test conducted ≤72 hours prior to randomization is acceptable. male or female patients ≥18 years of age at the time of signing informed consent. agree to use an adequate method of contraception throughout the study period and for 6 months after the dose of study drug is administered. women of childbearing potential (wocbp) must have a negative urinary pregnancy test at screening. main |
|
Exclusion criteria
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
have oxygen saturation (spo2) ≤93 % on room air at sea level or a ratio of arterial oxygen partial pressure (pao2 in millimeters of mercury) to fractional inspired oxygen (fio2) <300, respiratory rate ≥30 per minute, heart rate ≥125 per minute. have evidence of multi-organ dysfunction/failure. systolic blood pressure <90 mmhg, diastolic blood pressure <60 mmhg, or requiring vasopressors. require or anticipated impending need for endotracheal intubation, mechanical ventilation, oxygen delivered by high-flow nasal cannula noninvasive positive pressure ventilation, extracorporeal membrane oxygenation (ecmo). |
|
Number of arms
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Innovent Biologics (Suzhou) Co. Ltd. |
|
Inclusion age min
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Mild/moderate disease at enrollment |
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Severity scale
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
2: Mild/moderate disease at enrollment |
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Total sample size
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
222 |
|
primary outcome
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Number of treatment related AEs;Virologic efficacy Evaluation |
|
Notes
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
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Arms
Last imported at : Dec. 31, 2021, 5 a.m. Source : ClinicalTrials.gov |
[{"arm_notes": "Low dose", "treatment_id": 2086, "treatment_name": "Ibi314", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Medium dose", "treatment_id": 2086, "treatment_name": "Ibi314", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "High dose", "treatment_id": 2086, "treatment_name": "Ibi314", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}] |