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Trial - NCT04787211


Column Value
Trial registration number NCT04787211
Full text link
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04787211

First author
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

Yao Zhang

Contact
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

Lili Chen, lili.chen@briibio.com (PI email not reported)

Registration date
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2021-03-08

Recruitment status
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : March 9, 2021, 12:31 a.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 : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - subject ≥ 18 years, signing the informed consent. - sars-cov-2 infection by pcr ≤ 7 days - one or more of covid-19 related symptoms or measured fever present within 48 hours prior to study entry (subjects with mild-moderate covid-19)

Exclusion criteria
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- recurring covid-19 patients - subjects with any unstable conditions, a history of significant hypersensitivity, or known allergy to components of the investigational agent - receipt of convalescent covid-19 plasma, sars-cov-2 mab treatment, sars-cov-2 vaccine, or other investigational treatments prior to study entry

Number of arms
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Brii Biosciences Limited

Inclusion age min
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

China

Type of patients
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Moderate/severe disease at enrollment

Severity scale
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Jan. 26, 2022, 10:48 a.m.
Source : ClinicalTrials.gov

48

primary outcome
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Change from pre-dose baseline in Alanine aminotransferase (ALT) result;Change from pre-dose baseline in Creatine kinase result;Change from pre-dose baseline in Hemoglobin result;Change from pre-dose baseline in Platelets count;Change from pre-dose baseline in RBC count;Change from pre-dose baseline in WBC count;Incidence of adverse events (AEs);Incidence of serious adverse events (SAEs);Time-weighted average changes in SARSCoV-2 RNA levels in nasopharyngeal swabs from baseline to Day 8

Notes
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : March 9, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Group of moderate patients includes also mild patients. ", "treatment_id": 1433, "treatment_name": "Brii-196+brii-198", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]