COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49918

Junxue Wang

docd1@sina.com

2020-02-26

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Aged 18 to 75 years old, 2. Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the current diagnosis and treatment plan for pneumonia with new coronavirus infection, 3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days), 4. Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration, 5. Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration, 6. Patients who voluntarily sign informed consent.

1. The pneumonia patients with severe new coronavirus infection met one of the following conditions: respiratory distress, RR <=30 times / min, or SaO2 / SpO2 <=93% in resting state, or arterial partial pressure of oxygen (PaO2) / concentration of oxygen (FiO2) <=300MMHG (1mmhg = 0.133kpa), 2. Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation, or shock, or other organ failure combined with ICU monitoring treatment, 3.Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit), 4. Patients with contraindications specified in the instructions of danorevir and ritonavir tablets, 5. Patients who have taken or are taking protease inhibitor drugs, 6. The pregnancy test of female subjects in the screening period was positive, 7. The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period, patients with multiple basic diseases, etc.).

2

Shanghai Changzheng Hospital

18

75

China

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

60

Rate of composite advers outcomes: SpO2; PaO2/FiO2; respiratory rate;

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

Not reported

[{"arm_notes": "", "treatment_id": 1479, "treatment_name": "Danoprevir+ritonavir", "treatment_type": "Coagulation modifiers+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]