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Column | Value |
---|---|
Trial registration number | NCT04308317 |
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
First author
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
|
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 |
2020-03-16 |
Recruitment status
Last imported at : March 13, 2022, midnight Source : ClinicalTrials.gov |
Recruiting |
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 |
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 : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
inclusion criteria: - patients with mild and severe cases who have been diagnosed with new coronavirus pneumonia according to the "pneumonitis diagnosis and treatment - - plan for new coronavirus infection" - age 18 to 75 years; - sign the informed consent voluntarily. |
Exclusion criteria
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
- with active tuberculosis, idiopathic pulmonary fibrosis, bronchial asthma, bronchiectasis, pulmonary embolism, patients with chronic respiratory failure or other severe respiratory disease; - according to the "pneumonia diagnosis and treatment program for new coronavirus infection" (trial version 6), critically ill patients - with severe patients with disease of heart head blood-vessel, malignant arrhythmia, unstable angina, acute myocardial infarction and death, cardiac function level 3 and above, stroke, cerebral hemorrhage, etc.); - with severe liver and kidney diseases (severe liver disease refers to cirrhosis, portal hypertension and varices bleeding, severe kidney disease including dialysis, kidney transplantation); - pregnant and lactating women; - severe cognitive and mental disorders; - clinical investigators who were participating in other interventions within 1 month prior to inclusion |
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 |
Henan Provincial People's Hospital |
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 |
75 |
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 |
No restriction on type of patients |
Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
0: No restriction on type of patients |
Total sample size
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
60 |
primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
Survival rate |
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 4 |
Arms
Last imported at : Oct. 26, 2020, 11:31 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "", "treatment_id": 1281, "treatment_name": "Tetrandrine", "treatment_type": "Anti-inflammatories", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |