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

• ClinicalTrials.gov Identifier: NCT04261907
• Recruitment Status: Terminated
• First Posted: February 10, 2020
• Last Update Posted: April 4, 2022
• Sponsor: First Affiliated Hospital of Zhejiang University
• Collaborator: Ascletis Pharmaceuticals Co., Ltd.
• Information provided by (Responsible Party): First Affiliated Hospital of Zhejiang University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
2019-nCoV	Drug: ASC09/ritonavir group; Drug: lopinavir/ritonavir group	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection
• Actual Study Start Date: February 11, 2020
• Actual Primary Completion Date: April 13, 2020
• Actual Study Completion Date: April 13, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: ASC09/ritonavir group; ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment	Drug: ASC09/ritonavir group; ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment
Active Comparator: lopinavir/ritonavir group; Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment	Drug: lopinavir/ritonavir group; Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Time to recovery [ Time Frame: 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.
2. Rate of no fever [ Time Frame: 14 days ]
3. Rate of no cough [ Time Frame: 14 days ]
4. Rate of no dyspnea [ Time Frame: 14 days ]
5. Rate of no requring supplemental oxygen [ Time Frame: 14 days ]
6. Rate of undectable viral RNA [ Time Frame: 14 days ]
7. Rate of mechanical ventilation [ Time Frame: 14 days ]
8. Rate of ICU admission [ Time Frame: 14 days ]
9. Time and rate of laboratory indicators related to disease improvement to return to normal [ Time Frame: 14 days ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.)

Contacts and Locations

Locations

China, Zhejiang Province, P.R. China

The first affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang Province, P.R. China, China, 310003

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Ascletis Pharmaceuticals Co., Ltd.

Investigators

• Principal Investigator: Yunqing Qiu, Master; First Affiliated Hospital of Zhejiang University

More Information

• Responsible Party: First Affiliated Hospital of Zhejiang University
• ClinicalTrials.gov Identifier: NCT04261907
• Other Study ID Numbers: ASC09F-CTP-ZY-01
• First Posted: February 10, 2020
• Last Update Posted: April 4, 2022
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Coronavirus Infections; COVID-19; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Pneumonia, Viral; Pneumonia; Lung Diseases; Respiratory Tract Diseases; Ritonavir; Lopinavir; HIV Protease Inhibitors; Viral Protease Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anti-HIV Agents; Anti-Retroviral Agents; Antiviral Agents; Anti-Infective Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors