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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04261907
Recruitment Status : Not yet recruiting
First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Collaborator:
Ascletis Pharmaceuticals Co., Ltd.
Information provided by (Responsible Party):
First Affiliated Hospital of Zhejiang University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Estimated Study Start Date : February 7, 2020
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : June 30, 2020

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Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261907


Contacts
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Contact: Xiaowei Xu, Master +86 13605708066 xxw69@126.com
Contact: Jian Liu, Master +86 13958054006 lindaliu87@zju.edu.cn

Sponsors and Collaborators
First Affiliated Hospital of Zhejiang University
Ascletis Pharmaceuticals Co., Ltd.
Investigators
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Principal Investigator: Yunqing Qiu, Master First Affiliated Hospital of Zhejiang University
More Information
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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    Key Record Dates
Last Update Posted: February 10, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ritonavir
Lopinavir
 HIV 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