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Trial - NCT04551898


Column Value
Trial registration number NCT04551898
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04551898

First author
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Zhen Yao, MD

Contact
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

clinicaltrials@beigene.com

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-09-16

Recruitment status
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

key inclusion criteria: laboratory-confirmed severe acute respiratory syndrome (sars)-cov-2 infection (positive reverse transcription-polymerase chain reaction [rt-pcr] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening. have experienced covid-19 symptoms for ≤ 7 days prior to treatment assignment, such as fever, cough, shortness of breath, sore throat, diarrhea, vomiting, and dysgeusia agree to the collection of nasopharyngeal swabs, saliva, and venous blood key

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

severe covid-19 having oxygen saturation (spo2) ≤ 93 % on room air at sea level or ratio of arterial oxygen partial pressure (pao2 in millimeters of mercury) to fractional inspired oxygen (fio2) < 300, respiratory rate ≥ 30/min, heart rate ≥ 125/min requires mechanical ventilation or anticipated impending need for mechanical ventilation known allergies to any of the components used in the formulation of the interventions have received an investigational intervention for sars-cov-2 prophylaxis within 30 days before dosing have received treatment with a sars-cov-2 specific monoclonal antibody note: other protocol defined inclusion/exclusion criteria may apply.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

4

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

BeiGene

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

65

Countries
Last imported at : March 20, 2022, 9:56 a.m.
Source : ClinicalTrials.gov

Brazil;Mexico;South Africa;United States

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild/moderate disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : March 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

181

primary outcome
Last imported at : March 20, 2022, 9:56 a.m.
Source : ClinicalTrials.gov

Change From Baseline to Day 8 in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Shedding

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 198, "treatment_name": "Bgb dxp593", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 198, "treatment_name": "Bgb dxp593", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 198, "treatment_name": "Bgb dxp593", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]