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
Latest Information Update: 08 Apr 2022
At a glance
- Drugs ASC-09/ritonavir (Primary) ; Lopinavir/ritonavir
- Indications Coronavirus infections; COVID 2019 infections
- Focus Adverse reactions
- 23 Mar 2022 Status changed from not yet recruiting to discontinued.
- 17 Feb 2020 New trial record
Most Recent Events
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.
Comments
According to ClinicalTrials.gov record, this trial has been terminated as there were no patients enrolled.
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
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Number
Planned: 160
Actual: 6
- 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 |
---|---|
ChiCTR2000029603 | Chinese Clinical Trial Register |
NCT04261907 | ClinicalTrials.gov: US National Institutes of Health |
ASC09F-CTP-ZY01 | - |
Organisations
- Affiliations Ascletis
Trial Dates
-
Initiation Dates
Planned : 07 Feb 2020
Actual : 07 Feb 2020
-
Primary Completion Dates
Planned : 31 May 2020
Actual : 13 Apr 2020
-
End Dates
Planned : 30 Jun 2020
Actual : 13 Apr 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
show details
lindaliu87@zju.edu.cn |
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Xiaowei Xu, Master
+86 13605708066
show details
xxw69@126.com |
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Yunqing Qiu, Master | First Affiliated Hospital of Zhejiang University |
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Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
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Ascletis Pharmaceuticals Co., Ltd. |
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First Affiliated Hospital of Zhejiang University |
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Trial History
Event Date | Event Type | Comment |
---|---|---|
08 Apr 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 08 Apr 2022 |
23 Mar 2022 | Status change - discontinued | Status changed from not yet recruiting to discontinued. Updated 08 Apr 2022 |
03 Feb 2022 | Other trial event | According to ClinicalTrials.gov record, the recruitment status of this study is unknown because the information has not been verified recently(Last verified 6 February 2020). Updated 03 Feb 2022 |
22 Jun 2020 | Other trial event | New source identified and integrated (Chinese Clinical Trial Register: ChiCTR2000029603). Updated 22 Jun 2020 |
17 Feb 2020 | New trial record | New trial record Updated 17 Feb 2020 |
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org
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