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Trial - NCT04931238


Column Value
Trial registration number NCT04931238
Full text link
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04931238

First author
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Bin DU, Prof.

Contact
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

dubin98@gmail.com

Registration date
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

2021-06-18

Recruitment status
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Recruiting

Study design
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

multi-center

Study aim
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - severe acute respiratory syndrome coronavirus2 (sars-cov-2) infection - within 7 days from the onset of clinical symptoms or 4 days from the onset of severe symptoms - consistent with the national health committee new coronavirus pneumonia diagnosis and treatment plan (eighth edition), general or heavy diagnostic criteria.

Exclusion criteria
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

- sever covid-19 infection patients - sars-cov-2 specific antibodies (including igm and igg) were positive before included - cardiac function grade iii or iv, or left ventricular ejection fraction < 30% - history of known or suspected active pulmonary tuberculosis or extra-pulmonary tuberculosis - chronic renal failure needs maintenance dialysis - history of solid malignant/tumor or hematological malignancy - pregnancy or lactation

Number of arms
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Peking Union Medical College Hospital

Inclusion age min
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

85

Countries
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

200

primary outcome
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Clinical status at 28 days

Notes
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : Oct. 22, 2021, 10 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 484, "treatment_name": "Etesevimab", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]