A multicenter, randomized, open label, controlled trial for the efficacy and safety of ASC09/ Ritonavir compound tablets and Lopinavir/ Ritonavir (Kaletra) and Arbidol tablets in the treatment of novel coronavirus pneumonia (COVID-19)
Latest Information Update: 17 Jun 2020
At a glance
- Drugs ASC-09/ritonavir (Primary) ; Interferon; Lopinavir/ritonavir; Umifenovir
- Indications COVID 2019 infections
- Focus Therapeutic Use
- 20 Feb 2020 New trial record
Most Recent Events
Trial Overview
Purpose
This is a multicenter, randomized, open label, controlled trial for the efficacy and safety of ASC09/ Ritonavir compound tablets and Lopinavir/ Ritonavir (Kaletra) and Arbidol tablets in the treatment of novel coronavirus pneumonia (COVID-19).
Primary Endpoints
Time to recovery
clinical recovery was defined as sustained (48 hours) alleviation of illness based on symptom scores (fever, cough) [1]
Other Endpoints
rate of composite advers outcomes.;rate of no fever (Time Frame: 14 days);rate of no cough;rate of no dyspnea;rate of no requring supplemental oxygen;rate of undectable New coronavirus pathogen nucleic acid;rate of mechanical ventilation;rate of ICU admission; [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID 2019 infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 60
- Sex male & female
- Age Group 18-80 years; adult; elderly
Patient Inclusion Criteria
1. Aged 18- 80 years old; 2. Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (trial version 5); 3. Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days); 4. Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration; 5. Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration; 6. Patients who voluntarily sign informed consent.
Patient Exclusion Criteria
1. Severe liver disease (such as child Pugh score ≥ C, AST > 5 times upper limit); 2. The patients were allergic to the components in asc09 / ritonavir compound tablets; 3. Patients with contraindications specified in the instructions of ritonavir tablets; 4. The pregnancy test of female subjects in the screening period was positive; 5. Patients have treat with HIV protease inhibitor; 6. The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
Trial Details
Identifiers
Identifier | Owner |
---|---|
ChiCTR2000029759 | Chinese Clinical Trial Register |
2020 Lianhe (2) | - |
Trial Dates
-
Initiation Dates
Actual : 15 Feb 2020
-
End Dates
Planned : 01 May 2020
Other Details
- Design multicentre; open; parallel; prospective; randomised
- Phase of Trial Phase II
- Location China
- Focus Therapeutic Use
Interventions
Drugs | Route | Formulation |
---|---|---|
ASC-09/ritonavirPrimary Drug | Oral | Tablet |
Interferon | Inhalation | Aerosol |
Lopinavir/ritonavir | Oral | Tablet |
Umifenovir | Oral | Tablet |
control group 1:Lopinavir / Ritonavir (Kaletra) and IFN aerosol inhalation;control group 2:Abidol and IFN aerosol inhalation.;Experimental group:ASC09/ Ritonavir (ASC09F) and IFN aerosol inhalation;
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Peng Hu
Peng Hu
show details
hp_cq@163.com 74 Lingjiang Road, Yuzhong District, Chongqing, China |
The second Affiliated Hospital of Chongqing Medical University | China |
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
The second Affiliated Hospital of Chongqing Medical University
74 Lingjiang Road, Yuzhong District, Chongqing
show details
|
Yuzhong district, Chongqing | China |
Trial History
Event Date | Event Type | Comment |
---|---|---|
17 Jun 2020 | Other trial event | Last checked against China Clinical Trials Register record. Updated 17 Jun 2020 |
20 Feb 2020 | New trial record | New trial record Updated 20 Feb 2020 |
References
-
Chinese Clinical Trial Register. Trial-Reg 2021;.
Available from: URL: http://www.chictr.org
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