2019-nCoV PneumoniaPhase 3NCT04261270
A Randomized,Open,Controlled Clinical Study to Evaluate the Efficacy of ASC09F and Ritonavir for 2019-nCoV Pneumonia
A Phase 3 study testing ASC09F+Oseltamivir, Ritonavir+Oseltamivir and Oseltamivir in people with 2019-nCoV Pneumonia, run by Tongji Hospital at 1 site in China.
Trial summary
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- 2019-nCoV Pneumonia
- What is being tested?
- ASC09F+Oseltamivir, Ritonavir+Oseltamivir and Oseltamivir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Jul 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department and Institute of Infectious Disease
Wuhan, Hubei, 430030
Qin Ning, professor, qning@vip.sina.com
Meifang Han, professor, mfhan@foxmail.com
About this study
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
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
- Conditions
- 2019-nCoV Pneumonia
- Being tested
- ASC09F+Oseltamivir, Ritonavir+Oseltamivir, Oseltamivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC09F+OseltamivirDrug
ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
Ritonavir+OseltamivirDrug
Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
OseltamivirDrug
75mg ,once a day
| Study group | Role | What they receive |
|---|---|---|
| ASC09F+Oseltamivir | Experimental | Not described Receives: Drug: ASC09F+Oseltamivir |
| Ritonavir+Oseltamivir | Experimental | Not described Receives: Drug: Ritonavir+Oseltamivir |
| Oseltamivir | Experimental | Not described Receives: Drug: Oseltamivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of comprehensive adverse outcome
The definition of comprehensive adverse outcome is as follows:
- SPO2≤93% without oxygen inhalation;
- PaO2/FiO2≤300mmHg;
- RR≥30 bpm without oxygen inhalation.
Measured: 14 days
Secondary outcomes (9)
Time of clinical remission
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).
Measured: 28 days
Rate of no fever
Measured: 14 days
Rate of no cough
Measured: 14 days
Rate of no dyspnea
Measured: 14 days
Rate of no need for oxygen inhalation
Measured: 14 days
Rate of undetectable viral RNA
Measured: 14 days
Rate of mechanical ventilation
Measured: 28 days
Rate of ICU admission
Measured: 28 days
Rate and time of CRP,ES,Biochemical criterion(CK,ALT,Mb)recovery
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start1 Feb 2020
- Primary completion1 May 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoV PneumoniaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261270
- Sponsor's protocol ID
- ASC09F-CTP-TJ-01
- Status last verified
- Mar 2020
- First submitted
- 4 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04261270
- Acronym / sponsor ID
- ASC09F-CTP-TJ-01
- Conditions
- 2019-nCoV Pneumonia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASC09F+Oseltamivir | Experimental | Drug: ASC09F+Oseltamivir |
| Ritonavir+Oseltamivir | Experimental | Drug: Ritonavir+Oseltamivir |
| Oseltamivir | Experimental | Drug: Oseltamivir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 1.2019-nCoV severe Pneumonia patients.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASC09F+OseltamivirASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day | Drug | ASC09F+Oseltamivir |
| Ritonavir+OseltamivirRitonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day | Drug | Ritonavir+Oseltamivir |
| Oseltamivir75mg ,once a day | Drug | Oseltamivir |
Primary outcome
Rate of comprehensive adverse outcome
Time frame: 14 days
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.
9 secondary outcomes
Time of clinical remission
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ASC09F+Oseltamivir, Ritonavir+Oseltamivir and Oseltamivir in people with 2019-nCoV Pneumonia, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of comprehensive adverse outcome (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.