A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
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ClinicalTrials.gov Identifier: NCT04261270 |
Recruitment Status : Unknown
Verified March 2020 by Qin Ning, Tongji Hospital.
Recruitment status was: Recruiting
First Posted : February 7, 2020
Last Update Posted : March 17, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
2019-nCoV Pneumonia | Drug: ASC09F+Oseltamivir Drug: Ritonavir+Oseltamivir Drug: Oseltamivir | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | February 1, 2020 |
Estimated Primary Completion Date : | May 1, 2020 |
Estimated Study Completion Date : | July 1, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: ASC09F+Oseltamivir |
Drug: ASC09F+Oseltamivir
ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day |
Experimental: Ritonavir+Oseltamivir |
Drug: Ritonavir+Oseltamivir
Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day |
Experimental: Oseltamivir |
Drug: Oseltamivir
75mg ,once a day |
- Rate of comprehensive adverse outcome [ Time Frame: 14 days ]
The definition of comprehensive adverse outcome is as follows:
- SPO2≤93% without oxygen inhalation;
- PaO2/FiO2≤300mmHg;
- RR≥30 bpm without oxygen inhalation.
- Time of clinical remission [ Time Frame: 28 days ]
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).
- 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 ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age:18~55 years old, unlimited gender.
- Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
- Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
- 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.
- Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
- 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):
- Respiratory distress ,RR≥30 bpm;
- In a resting state:SPO2≤93%;
-
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04261270
Contact: Qing Ning, Professor | +8613971521450 | qning@vip.sina.com | |
Contact: Meifang Han, Professor | +8613986093605 | mfhan@foxmail.com |
China, Hubei | |
Department and Institute of Infectious Disease | Recruiting |
Wuhan, Hubei, China, 430030 | |
Contact: Qin Ning, professor qning@vip.sina.com | |
Contact: Meifang Han, professor mfhan@foxmail.com |
Responsible Party: | Qin Ning, Professor, Tongji Hospital |
ClinicalTrials.gov Identifier: | NCT04261270 |
Other Study ID Numbers: |
ASC09F-CTP-TJ-01 |
First Posted: | February 7, 2020 Key Record Dates |
Last Update Posted: | March 17, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Ritonavir Oseltamivir HIV Protease Inhibitors Viral Protease Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |