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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)

Trial Profile

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: Recruiting
Phase of Trial: Phase II

Latest Information Update: 20 Feb 2020

At a glance

  • Drugs ASC-09/ritonavir (Primary) ; Interferon; Lopinavir/ritonavir; Umifenovir
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 20 Feb 2020 New trial record

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.

Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≤30 breaths per min without supplemental oxygen (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. The age is 18- 80 years old (including boundary value), and the gender is unlimited 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
Sample size20
Lopinavir / Ritonavir (Kaletra) and IFN aerosol inhalation

control group 2
Sample size20
Abidol and IFN aerosol inhalation.

Experimental group
Sample size20
ASC09/ Ritonavir (ASC09F) and IFN aerosol inhalation

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Peng Hu
Peng Hu
hp_cq@163.com
74 Lingjiang Road, Yuzhong District, Chongqing, China
show details
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
20 Feb 2020 New trial record New trial record Updated 20 Feb 2020

References

  1. Chinese Clinical Trial Register. Trial-Reg 2016;.

    Available from: URL: http://www.chictr.org
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