Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection

• Status: Not yet recruiting
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

Summary

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborator: Ascletis Pharmaceuticals Co., Ltd.
• Treatments: Lopinavir; Ritonavir

Criteria

Inclusion Criteria:

• 1. Aged between 18 and 75 years, extremes included, male or female

• 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"

• 3. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)

• 4. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose

• 5. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study

• 6. Informed Consent Form (ICF) signed voluntarily

Exclusion Criteria:

• 1. Severe 2019-nCoV pneumonia met one of the following criteria: 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. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment

• 3. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)

• 4. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets

• 5. Patients with definite contraindications in the label of ritonavir

• 6. Positive serum pregnancy test result for women with childbearing potential at screening

• 7. Using HIV protease inhibitor drugs

• 8. Not suitable for the study, in the opinion of the Investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)