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

Primary Purpose

2019-nCoV

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ASC09/ritonavir group
lopinavir/ritonavir group
Sponsored by
First Affiliated Hospital of Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for 2019-nCoV

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • The first affiliated hospital, Zhejiang University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ASC09/ritonavir group

lopinavir/ritonavir group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Rate of no fever
Rate of no cough
Rate of no dyspnea
Rate of no requring supplemental oxygen
Rate of undectable viral RNA
Rate of mechanical ventilation
Rate of ICU admission
Time and rate of laboratory indicators related to disease improvement to return to normal

Full Information

First Posted
February 6, 2020
Last Updated
March 23, 2022
Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Ascletis Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT04261907
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
There were no more subjects enrolled.
Study Start Date
February 11, 2020 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
Ascletis Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019-nCoV

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASC09/ritonavir group
Arm Type
Experimental
Arm Description
ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment
Arm Title
lopinavir/ritonavir group
Arm Type
Active Comparator
Arm Description
Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment
Intervention Type
Drug
Intervention Name(s)
ASC09/ritonavir group
Intervention Description
ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment
Intervention Type
Drug
Intervention Name(s)
lopinavir/ritonavir group
Intervention Description
Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment
Primary Outcome Measure Information:
Title
The incidence of composite adverse outcome
Description
Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time to recovery
Description
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.
Time Frame
14 days
Title
Rate of no fever
Time Frame
14 days
Title
Rate of no cough
Time Frame
14 days
Title
Rate of no dyspnea
Time Frame
14 days
Title
Rate of no requring supplemental oxygen
Time Frame
14 days
Title
Rate of undectable viral RNA
Time Frame
14 days
Title
Rate of mechanical ventilation
Time Frame
14 days
Title
Rate of ICU admission
Time Frame
14 days
Title
Time and rate of laboratory indicators related to disease improvement to return to normal
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunqing Qiu, Master
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The first affiliated hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang Province, P.R. China
ZIP/Postal Code
310003
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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