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

2019-nCoV Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04261907
• Other study ID #: ASC09F-CTP-ZY-01
• Status: Terminated
• Phase: N/A
• Start date: February 11, 2020
• Est. completion date: April 13, 2020

Study information

• Verified date: February 2020
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.)

Related Conditions & MeSH terms

• 2019-nCoV
• Coronavirus Infections
• COVID-19

Intervention

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

Locations

Country	Name	City	State
China	The first affiliated hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang Province, P.R. China

Sponsors (2)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University	Ascletis Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of composite adverse outcome	Defined as(one of them) SPO2= 93% without oxygen supplementation, PaO2/FiO2 = 300mmHg or RR = 30 breaths per.	14 days
Secondary	Time to recovery	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.	14 days
Secondary	Rate of no fever		14 days
Secondary	Rate of no cough		14 days
Secondary	Rate of no dyspnea		14 days
Secondary	Rate of no requring supplemental oxygen		14 days
Secondary	Rate of undectable viral RNA		14 days
Secondary	Rate of mechanical ventilation		14 days
Secondary	Rate of ICU admission		14 days
Secondary	Time and rate of laboratory indicators related to disease improvement to return to normal		14 days