Clinical trial NCT04261907: Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 2019-nCoV
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ascletis Pharmaceuticals Co., Ltd.
First posted: 2020-02-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.)

Primary outcomes:
measure: The incidence of composite adverse outcome
timeFrame: 14 days
Secondary outcomes:
measure: Time to recovery
timeFrame: 14 days
measure: Rate of no fever
timeFrame: 14 days
measure: Rate of no cough
timeFrame: 14 days
measure: Rate of no dyspnea
timeFrame: 14 days
measure: Rate of no requring supplemental oxygen
timeFrame: 14 days
measure: Rate of undectable viral RNA
timeFrame: 14 days
measure: Rate of mechanical ventilation
timeFrame: 14 days
measure: Rate of ICU admission
timeFrame: 14 days
measure: Time and rate of laboratory indicators related to disease improvement to return to normal
timeFrame: 14 days
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The first affiliated hospital, Zhejiang University School of Medicine
state: Zhejiang Province, P.R. China
Study officials:
affiliation: First Affiliated Hospital of Zhejiang University
name: Yunqing Qiu, Master
role: PRINCIPAL_INVESTIGATOR
References: