COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=49075

Qiu Yunqing

qiuyq@zju.edu.cn

2020-02-06

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

1. Aged 18-75 years old, 2. Patients with novel coronavirus infection pneumonia were confirmed by RT-PCR and clinical symptoms. The diagnostic criteria refer to Pneumonitis Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5) , 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 partners who have no planned pregnancy within the past six months, 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 studies within 30 days from the first administration of the study drug to the last administration, 6. Patients who voluntarily signed informed consent.

1. Patients with severe 2019-nCoV pneumonia 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. Patients with critical 2019-nCoV pneumonia met one of the following conditions: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment, 3. Severe liver disease (such as child Pugh score >= C, AST > 5 times upper limit), 4. Patients were allergic to the components of ASC09 / ritonavir compound tablets, 5. Patients with definite contraindications in the label of ritonavir tablets, 6. Female subjects pregnancy test was positive during the screening period, 7. Patients who are taking HIV protease inhibitor drugs, 8. Physician judged the patient was not suitable for this clinical trial (for example, patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.).

2

The First Affiliated Hospital of Zhejiang University School of Medicine

18

75

China

Mild disease at enrollment

1: Mild disease at enrollment

160

The incidence of composite adverse outcome within 14 days after admission: Defined as (one of them) SPO2<= 93% without oxygen supplementation; PaO2/FiO2 <= 300mmHg or RR <=30 breaths per minute.;

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

Phase 0

[{"arm_notes": "", "treatment_id": 1414, "treatment_name": "Asc09+ritonavir", "treatment_type": "Anti-inflammatories+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]