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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

Trial Profile

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

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2020

At a glance

  • Drugs ASC-09/ritonavir (Primary) ; Oseltamivir (Primary) ; Ritonavir (Primary)
  • Indications Coronavirus infections; COVID 2019 infections; Pneumonia
  • Focus Adverse reactions
  • Most Recent Events

    • 09 Mar 2020 Status changed from not yet recruiting to recruiting.
    • 24 Feb 2020 New trial record

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
Coronavirus infections treatment -
COVID 2019 infections treatment -
Pneumonia treatment -

Subjects

  • Subject Type patients
  • 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

  • Initiation Dates

    Planned : 01 Feb 2020

    Actual : 01 Feb 2020

  • Primary Completion Dates

    Planned : 01 May 2020

  • 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
-

Centres

Centre Name Location Trial Centre Country
-
-
-
Department and Institute of Infectious Disease Wuhan, Hubei China
Tongji Hospital
-
-

Trial History

Event Date Event Type Comment
13 Mar 2020 Other trial event Last checked against ClinicalTrials.gov record. Updated 13 Mar 2020
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

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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