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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

Trial Profile

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

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 17 Feb 2020

At a glance

  • Drugs ASC-09/ritonavir (Primary) ; Lopinavir/ritonavir
  • Indications Coronavirus infections; COVID 2019 infections
  • Focus Adverse reactions
  • Most Recent Events

    • 17 Feb 2020 New trial record

Trial Overview

Purpose

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.

Primary Endpoints

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

Other Endpoints

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

Rate of no fever

time_frame: 14 days

Rate of no cough

time_frame: 14 days

Rate of no dyspnea

time_frame: 14 days

Rate of no requring supplemental oxygen

time_frame: 14 days

Rate of undectable viral RNA

time_frame: 14 days

Rate of mechanical ventilation

time_frame: 14 days

Rate of ICU admission

time_frame: 14 days

Time and rate of laboratory indicators related to disease improvement to return to normal

time_frame: 14 days [1]

Diseases Treated

Indication Qualifiers Patient Segments
Coronavirus infections treatment -
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 160

  • Sex male & female
  • Age Group 18-75 years; adult; elderly

Patient 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

Patient 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.)

Trial Details

Identifiers

Identifier Owner
NCT04261907 ClinicalTrials.gov: US National Institutes of Health
ASC09F-CTP-ZY01 -

Organisations

  • Affiliations Ascletis

Trial Dates

  • Initiation Dates

    Planned : 07 Feb 2020

  • Primary Completion Dates

    Planned : 31 May 2020

  • End Dates

    Planned : 30 Jun 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location China
  • Focus Adverse reactions

Interventions

Drugs Route Formulation
ASC-09/ritonavirPrimary Drug Oral Tablet
Lopinavir/ritonavir Oral Tablet

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)

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)

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Jian Liu, Master
+86 13958054006
lindaliu87@zju.edu.cn
show details
-
Xiaowei Xu, Master
+86 13605708066
xxw69@126.com
show details
-
Yunqing Qiu, Master First Affiliated Hospital of Zhejiang University
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Ascletis Pharmaceuticals Co., Ltd.
-
-
First Affiliated Hospital of Zhejiang University
-
-

Trial History

Event Date Event Type Comment
17 Feb 2020 New trial record New trial record Updated 17 Feb 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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