COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49790

Xu Zhihua

1121733818@qq.com

2020-03-06

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

1. Aged 18 to 75 years, 2. Real-time fluorescence RT-PCR detection of nucleic acid positive of novel coronavirus in respiratory tract specimens or blood preparation, 3. Sequencing of virus genes in respiratory tract specimens or blood preparation, highly homologous to known novel coronavirus , 4. The patients are diagnosed with common type of novel coronavirus pneumonia according to the Pneumonia Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6), and have fever and/or respiratory symptoms, and shows pneumonia in the chest CT. 5. Can be included in some severe patients, consistent with any of the following: (1) Respiratory distress, RR >= 30 times/min, (2) Under quiescent condition, Oxygen saturation <= 93%, (3) Arterial partial pressure of oxygen(PaO2)/oxygen concentration(FiO2)<= 300mmHg.

(1) Combined with high blood pressure, diabetes, coronary heart disease and other underlying disease, (2) Combined with malignant tumor or a medical history of malignant tumor, (3) Pregnant or lactating women, (4) Suffering from severe mental illness, (5) Medical history of unstable angor pectoris or myocardial?infarction within 6 months, coronary arteriography, it indicates severe stenosis of the main branch of the coronary artery, (6) Medical history of cerebral infarction or cerebral hemorrhage within 6 months, (7) Intolerant or allergic to interferon preparations, (8) The investigator determined that the patients were not eligible for the trial.

2

Wuhan Red Cross Hospital

18

75

China

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

100

Clinical therapeutic course;Pathogenic detectio;Chest CT;Laboratory indicators (blood routine; myocardial enzyme spectrum; inflammatory cytokines; etc.);

| Declared number of arm (2.0) differs from found arms (3.0)

Phase 4

[{"arm_notes": "", "treatment_id": 1590, "treatment_name": "Interferon alpha+lopinavir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1602, "treatment_name": "Ebastine+interferon alpha+lopinavir", "treatment_type": "Respiratory agents+interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}]