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Retracted due to lack of patient 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 treatm

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)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029759
Enrollment
Unknown
Registered
2020-02-12
Start date
2020-02-15
Completion date
Unknown
Last updated
2020-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Novel Coronavirus Pneumonia (COVID-19)

Interventions

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

Sponsors

The Second Affiliated Hospital of Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

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.

Exclusion criteria

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.).

Design outcomes

Primary

MeasureTime frame
time to recovery.;

Secondary

MeasureTime frame
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;

Countries

China

Contacts

Public ContactPeng Hu

The Second Affiliated Hospital of Chongqing Medical University

hp_cq@163.com+86 13608338064

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026