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

Zhejiang University

Status

Terminated

Conditions

2019-nCoV

Treatments

Drug: lopinavir/ritonavir group

Drug: ASC09/ritonavir group

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT04261907

ASC09F-CTP-ZY-01

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

1. Aged between 18 and 75 years, extremes included, male or female
1. 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)"
1. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
1. 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
1. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
1. 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)
1. 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
1. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)
1. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
1. Patients with definite contraindications in the label of ritonavir
1. Positive serum pregnancy test result for women with childbearing potential at screening
1. Using HIV protease inhibitor drugs
1. 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.)