Clinical trial NCT04261270: A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: 2019-nCoV Pneumonia
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.


Eligibility criteria: 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.

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)

Primary outcomes:
measure: Rate of comprehensive adverse outcome
timeFrame: 14 days
Secondary outcomes:
measure: Time of clinical remission
timeFrame: 28 days
measure: Rate of no fever
timeFrame: 14 days
measure: Rate of no cough
timeFrame: 14 days
measure: Rate of no dyspnea
timeFrame: 14 days
measure: Rate of no need for oxygen inhalation
timeFrame: 14 days
measure: Rate of undetectable viral RNA
timeFrame: 14 days
measure: Rate of mechanical ventilation
timeFrame: 28 days
measure: Rate of ICU admission
timeFrame: 28 days
measure: Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
timeFrame: 28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department and Institute of Infectious Disease
state: Hubei
Study officials:
References: