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Column | Value |
---|---|
Trial registration number | ChiCTR2000029776 |
Full text link
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
First author
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
|
Contact
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
zjwzhxy@126.com |
Registration date
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2020-02-13 |
Recruitment status
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Recruiting |
Study design
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
RCT |
Allocation
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Randomized |
Design
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Parallel |
Masking
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Open label |
Center
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
multi-center |
Study aim
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Treatment |
Inclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1. Patients with confirmed new coronavirus-infected pneumonia, 2. Above 18 years old (inclusive), 3. Voluntarily sign written informed consent. |
Exclusion criteria
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
1. Severe pneumonia requires mechanical ventilationcritically severe cases, 2. Estimated Time of Death is less than 48 hours, 3. There is clear evidence of bacterial infection in respiratory tract infections caused by basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformations, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development, 4. Subjects with the following conditions: asthma requiring daily treatment, any other chronic respiratory disease, respiratory bacterial infections such as purulent tonsillitis, acute tracheobronchitis, sinusitis, otitis media, and other respiratory tracts diseases that affecting clinical trial evaluation. Chest CT confirmed that patients with basic pulmonary diseases such as severe pulmonary interstitial lesions and bronchiectasis, 5. In the opinion of the investigator, previous or present illnesses may affect patients' participation in the trial or influence the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease, currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, organ transplantation, etc., 6. Mental state unable to cooperate, suffering from mental illness, unable to control, unable to express clearly 7. An allergic condition, such as a history of allergies to two or more drugs or foods, or a known allergy to the ingredients of the drug, 8. Patients with a history of substance abuse or dependence, 9. Pregnant or lactating women, 10. Patients who participated in other clinical trials within the last 3 months, 11. The investigator believes that there are any factors that are not suitable for enrollment or affect the evaluation of the efficacy. |
Number of arms
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
2 |
Funding
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
The First Affiliated of Wenzhou Medical University |
Inclusion age min
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
18 |
Inclusion age max
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
None |
Countries
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
China |
Type of patients
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Moderate disease at enrollment |
Severity scale
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
3: Moderate disease at enrollment |
Total sample size
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
40 |
primary outcome
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Time to Clinical recovery; |
Notes
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
| Declared number of arm (2.0) differs from found arms (3.0) |
Phase
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
Phase 4 |
Arms
Last imported at : Oct. 26, 2020, 8:29 a.m. Source : International Clinical Trials Registry Platform (ICTRP) |
[{"arm_notes": "", "treatment_id": 1010, "treatment_name": "Polyinosinic-polycytidylic acid", "treatment_type": "Others pharmacological treatment", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |