A Phase 3 interventional study of ASC09F+Oseltamivir and Ritonavir+Oseltamivir in 2019-nCoV Pneumonia, sponsored by Tongji Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-03-17.
Sponsored by Tongji Hospital · Phase 3, Interventional, and Treatment
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Tongji Hospital is the lead sponsor of 384 studies on the registry; 208 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
1.2019-nCoV severe Pneumonia patients.
Meet the definition of severe pneumonia(Comply with any of the followings):
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)
Drug: ASC09F+Oseltamivir
Drug: Ritonavir+Oseltamivir
Drug: Oseltamivir
Drug page: Oseltamivir
ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Drug pages: Ritonavir · Oseltamivir
Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
75mg ,once a day
Rate of comprehensive adverse outcome
The definition of comprehensive adverse outcome is as follows: 1. SPO2≤93% without oxygen inhalation; 2. PaO2/FiO2≤300mmHg; 3. RR≥30 bpm without oxygen inhalation.
Time frame: 14 days
Time of clinical remission
The definition of clinical remission: 1. Based on the symptoms of the disease (fever,cough,diarrhea,myalgia,dyspnea) has been relieved for 48 hours; 2. 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
Plan to share: Undecided
No publications or documents are linked to this record.
Started Feb 2020 (actual). Primary completion is estimated for May 2020, 3 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Oseltamivir · Ritonavir