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Trial - NCT04273763


Column Value
Trial registration number NCT04273763
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04273763

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

XIAN SHEN, phd

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

Not reported

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

2020-02-18

Recruitment status
Last imported at : April 5, 2022, 8:30 p.m.
Source : ClinicalTrials.gov

Not reported

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

Sequential assignment

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

Open label

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

single-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

inclusion criteria: aged between 18 and 80 years (including 18and 80years, male or female). one of them: laboratory (rt-pcr) and clinical symptoms confirmed case of novel coronavirus pneumonia (covid-19). patients diagnosed clinically as suspected cases. ability to communicate well with researchers and sign the informed consent form (icf) voluntarily.

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

- alt≥5 times of uln, level of total bilirubin≥3 times of uln, or cr≥1.5 times of uln. - patients with serious severe liver disease. - excluded who diagnosed as pneumonia patients with novel coronavirus infection of severe type and critical type. 【diagnostic criteria reference the official guideline "pneumonia diagnosis and treatment scheme for novel coronavirus infection (trial version 5) "】. - patients with previous history of severe gastrointestinal diseases such as gastric ulcers and bleeding. - patients with lactose intolerance. - patients who are allergic to the components of this medicine (major components: bromhexine hydrochloride; excipient: starch, lactose, magnesium stearate). - positive serum pregnancy test result for women with childbearing potential at screening or lactating women. - other circumstances that the researcher considers inappropriate to participate in this study.

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

2

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

Second Affiliated Hospital of Wenzhou Medical University

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

80

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

China

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

Mild disease at enrollment

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

1: Mild disease at enrollment

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

18

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

Time to clinical recovery after treatment;Rate of aggravation

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

None

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

Not reported

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

[{"arm_notes": "nan", "treatment_id": 1725, "treatment_name": "Bromhexine+interferon alpha+umifenovir", "treatment_type": "Respiratory agents+interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "nan", "treatment_id": 1724, "treatment_name": "Interferon alpha+umifenovir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]