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

NCT ID: NCT04261907

Last Updated: 2022-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-11
• Study Completion Date: 2020-04-13

Brief 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.

Conditions

2019-nCoV

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ASC09/ritonavir group

ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment

Group Type: EXPERIMENTAL

ASC09/ritonavir group

Intervention Type: DRUG

ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment

lopinavir/ritonavir group

Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment

Group Type: ACTIVE_COMPARATOR

lopinavir/ritonavir group

Intervention Type: DRUG

Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment

Interventions

ASC09/ritonavir group

ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment

Intervention Type: DRUG

lopinavir/ritonavir group

Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment

Intervention Type: DRUG

Eligibility 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascletis Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yunqing Qiu, Master

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Zhejiang University

Locations

The first affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang Province, P.R. China, China

Countries

China

Other Identifiers

ASC09F-CTP-ZY-01

Identifier Type: -

Identifier Source: org_study_id