A Randomized,Open,Controlled Small Sample Clinical Study to Evaluate the Efficacy and Safety of ASC09/Ritonavir Compound Tablets and Ritonavir for 2019-nCoV Pneumonia
Latest Information Update: 07 Mar 2022
At a glance
- Drugs ASC-09/ritonavir (Primary) ; Oseltamivir (Primary) ; Ritonavir (Primary)
- Indications Coronavirus infections; COVID 2019 infections; Pneumonia
- Focus Adverse reactions
- 09 Mar 2020 Status changed from not yet recruiting to recruiting.
- 24 Feb 2020 New trial record
Most Recent Events
Trial Overview
Purpose
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Primary Endpoints
Rate of comprehensive adverse outcome
description: The definition of comprehensive adverse outcome is as follows:
SPO2≤93% without oxygen inhalation;
PaO2/FiO2≤300mmHg;
RR≥30 bpm without oxygen inhalation.
time_frame: 14 days
Other Endpoints
Time of clinical remission
description: The definition of clinical remission:
Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours;
There is no evidence of disease progression(New dyspnea, SpO2 decreased≥3%,RR≥30 bpm without oxygen inhalation).
time_frame: 28 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 need for oxygen inhalation
time_frame: 14 days
Rate of undetectable viral RNA
time_frame: 14 days
Rate of mechanical ventilation
time_frame: 28 days
Rate of ICU admission
time_frame: 28 days
Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
time_frame: 28 days [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
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Coronavirus infections | treatment | - |
COVID 2019 infections | treatment | - |
Pneumonia | treatment | - |
Subjects
- Subject Type patients
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Number
Planned: 60
- Sex male & female
- Age Group 18-55 years; adult
Patient Inclusion Criteria
1. Age:18~55 years old, unlimited gender. 2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations. 3. Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days). 4. Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose. 5. Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose. 6. Patients who voluntarily sign informed consent forms.
Patient Exclusion Criteria
1.2019-nCoV severe Pneumonia patients. Meet the definition of severe pneumonia(Comply with any of the followings): 1. Respiratory distress ,RR≥30 bpm; 2. In a resting state:SPO2≤93%; 3. PaO2/ FiO2≤300mmHg. 2.2019-nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment. 3.Severe liver disease(such as:the ChildPugh score≥C;AST > 5 times the upper limit). 4.Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets. 5.Patients with definite contraindications in ritonavir tablets. 6.Female subjects were positive for the pregnancy test during the screening period. 7.Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc)
Trial Details
Identifiers
Identifier | Owner |
---|---|
NCT04261270 | ClinicalTrials.gov: US National Institutes of Health |
ASC09F-CTP-TJ01 | - |
Trial Dates
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Initiation Dates
Planned : 01 Feb 2020
Actual : 01 Feb 2020
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Primary Completion Dates
Planned : 01 May 2020
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End Dates
Planned : 01 Jul 2020
Other Details
- Design open; parallel; prospective; randomised
- Phase of Trial Phase III
- Location China
- Focus Adverse reactions
Interventions
Drugs | Route | Formulation |
---|---|---|
ASC-09/ritonavirPrimary Drug | Oral | Tablet |
OseltamivirPrimary Drug | Oral | Tablet |
RitonavirPrimary Drug | Oral | Tablet |
ASC09F+Oseltamivir
Drug: ASC09F+Oseltamivir (ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day)
Ritonavir+Oseltamivir
Drug: Ritonavir+Oseltamivir (Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day)
Oseltamivir
Drug: Oseltamivir (75mg ,once a day)
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Meifang Han, professor
+8613986093605 mfhan@foxmail.com
show details
|
, Department and Institute of Infectious Disease | China |
Qing Ning, Professor
+8613971521450 qning@vip.sina.com
show details
|
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Centres
Centre Name | Location | Trial Centre Country |
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- |
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Department and Institute of Infectious Disease | Wuhan, Hubei | China |
Tongji Hospital |
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Trial History
Event Date | Event Type | Comment |
---|---|---|
07 Mar 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Mar 2020) Updated 07 Mar 2022 |
07 Mar 2022 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 07 Mar 2022 |
09 Mar 2020 | Status change - recruiting | Status changed from not yet recruiting to recruiting. Updated 13 Mar 2020 |
24 Feb 2020 | New trial record | New trial record Updated 24 Feb 2020 |
References
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ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov
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