COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49065

Li Lanjuan

ljli@zju.edu.cn

2020-02-05

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

o be enrolled, all the following criteria must be met: 1) the confirmed patient (or legal guardian) agrees to participate in the study and signs the informed consent, 2) Aged 18-65 years, gender not limited, 3) the time interval between symptom onset and random enrollment was within 8 days (symptom onset was mainly determined by the time of fever), 4) real-time fluorescence rt-pcr detection of respiratory tract or blood samples in patients with positive nucleic acid of novel coronavirus, 5) diagnosis of mild, common or severe cases according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus (trial version 5): A. Mild: the clinical symptoms were mild, and no pneumonia was found on imaging, B. Common type: symptoms such as fever and respiratory tract, and manifestations of pneumonia can be seen on imaging, C. Heavy: meets any of the following: A. respiratory distress, respiratory frequency >= 30 times/min, B. At rest, oxygen saturation (SaO2) <= 93%, C. Arterial partial oxygen pressure (PaO2)/oxygen absorption concentration (FiO2) <= 300mmHg.

You cannot be enrolled if you meet any of the following criteria: 1) any situation that cannot allow the program to proceed safely, 2) allergic constitution, allergic to more than one kind of food or medicine, 3) patients with severe basic diseases that affect survival, including uncontrolled clinically significant heart, lung, kidney, digestion, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, and severe malnutrition, 4) pregnant or lactating women, 5) patients may be transferred to non-participating hospitals within 72 hours, 6) patients who have been on immunosuppressive agents or organ transplants for nearly 6 months, 7) critically ill patients diagnosed according to the diagnosis and treatment plan for pneumonia caused by novel coronavirus infection (trial fifth edition), 8) those who are unable to cooperate in mental state, suffer from mental illness, have no self-control and cannot express clearly, 9) a history of HBV, HCV, TPPA, HIV and pancreatitis before infection, 10) participants in other clinical trials.

4

The First Affiliated Hospital of Medical College of Zhejiang University

18

65

China

Mild disease at enrollment

1: Mild disease at enrollment

480

The time required for RNA Yin conversion of novel coronavirus in respiratory or blood specimens was compared between treatment groups The difference of;

| Declared number of arm (3.0) differs from found arms (5.0)

Phase 4

[{"arm_notes": "", "treatment_id": 105, "treatment_name": "Antiviral therapy", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 105, "treatment_name": "Antiviral therapy", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 667, "treatment_name": "Interferon alpha2b", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}]