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

Not Applicable

Terminated

• Conditions: 2019-nCoV
• Interventions: Drug: ASC09/ritonavir group; Drug: lopinavir/ritonavir group

• Registration Number: NCT04261907
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-06
• Study First Submitted QC: 2020-02-06
• Study First Posted: 2020-02-10
• Study Start: 2020-02-11
• Primary Completion: 2020-04-13
• Study Completion: 2020-04-13
• Last Update Submitted: 2022-03-23
• Last Update Posted: 2022-04-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC09/ritonavir group	ASC09/ritonavir group	ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment
lopinavir/ritonavir group	lopinavir/ritonavir group	Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment

Primary Outcome Measures

Name	Time	Method
The incidence of composite adverse outcome	14 days	Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.

Secondary Outcome Measures

Name	Time	Method
Rate of ICU admission	14 days
Rate of undectable viral RNA	14 days
Rate of mechanical ventilation	14 days
Time and rate of laboratory indicators related to disease improvement to return to normal	14 days
Rate of no fever	14 days
Time to recovery	14 days	Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.
Rate of no cough	14 days
Rate of no dyspnea	14 days
Rate of no requring supplemental oxygen	14 days

Trial Locations

Locations (1)

The first affiliated hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang Province, P.R. China, China