Clincosm LogoSign in Get a demo

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

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Terminated
CT.gov ID
NCT04261907
Collaborator
Ascletis Pharmaceuticals Co., Ltd. (Industry)
6
Enrollment
1
Location
2
Arms
2
Actual Duration (Months)
2.9
Patients Per Site Per Month

Study Details

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
  • Drug: ASC09/ritonavir group
  • Drug: lopinavir/ritonavir group
 N/A

Study Design

Study Type:
Interventional
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 :
Feb 11, 2020
Actual Primary Completion Date :
Apr 13, 2020
Actual Study Completion Date :
Apr 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 [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 [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 [14 days]

  3. Rate of no cough [14 days]

  4. Rate of no dyspnea [14 days]

  5. Rate of no requring supplemental oxygen [14 days]

  6. Rate of undectable viral RNA [14 days]

  7. Rate of mechanical ventilation [14 days]

  8. Rate of ICU admission [14 days]

  9. Time and rate of laboratory indicators related to disease improvement to return to normal [14 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
    1. Aged between 18 and 75 years, extremes included, male or female
    1. 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)"
    1. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
    1. 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
    1. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
    1. 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)
    1. 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
    1. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)
    1. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
    1. Patients with definite contraindications in the label of ritonavir
    1. Positive serum pregnancy test result for women with childbearing potential at screening
    1. Using HIV protease inhibitor drugs
    1. 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

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital of Zhejiang University
ClinicalTrials.gov Identifier:
NCT04261907
Other Study ID Numbers:
  • ASC09F-CTP-ZY-01
First Posted:
Feb 10, 2020
Last Update Posted:
Apr 4, 2022
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
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
Ritonavir
Lopinavir

Study Results

No Results Posted as of Apr 4, 2022