2019-nCoVNCT04261907
Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Novel Coronavirus Infection
A study testing ASC09/ritonavir group and lopinavir/ritonavir group in people with 2019-nCoV, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- 2019-nCoV
- What is being tested?
- ASC09/ritonavir group and lopinavir/ritonavir group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 11 Feb 2020to 13 Apr 2020
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Aged between 18 and 75 years, extremes included, male or female
- 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"
- 3. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
- 4. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose
- 5. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
- 6. Informed Consent Form (ICF) signed voluntarily
Who cannot join
- 1. Severe 2019-nCoV pneumonia met one of the following criteria: respiratory distress, RR ≥ 30 times / min, or SaO2 / SpO2 ≤ 93% in resting state, or arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg (1mmHg = 0.133kpa)
- 2. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment
- 3. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)
- 4. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
- 5. Patients with definite contraindications in the label of ritonavir
- 6. Positive serum pregnancy test result for women with childbearing potential at screening
- 7. Using HIV protease inhibitor drugs
- 8. Not suitable for the study, in the opinion of the Investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang Province, P.R. China, 310003
About this study
Official title: A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection
Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.
- Conditions
- 2019-nCoV
- Being tested
- ASC09/ritonavir group, lopinavir/ritonavir group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC09/ritonavir groupDrug
ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment
lopinavir/ritonavir groupDrug
Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment
| Study group | Role | What they receive |
|---|---|---|
| ASC09/ritonavir group | Experimental | ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment Receives: Drug: ASC09/ritonavir group |
| lopinavir/ritonavir group | Active comparator | Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment Receives: Drug: lopinavir/ritonavir group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of composite adverse outcome
Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.
Measured: 14 days
Secondary outcomes (9)
Time to recovery
Clinical recovery was defined as( one of them): sustained (48 hours) alleviation of illness based on symptom scores (fever, cough,diarrhea, myalgia, dyspnea) all being absent and no evidence for progression (newly-presented dyspnea, SpO2 decline ≥3%, respiratory rate ≥ 24 breaths per min without supplemental oxygen). Or undectable viral RNA.
Measured: 14 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 requring supplemental oxygen
Measured: 14 days
Rate of undectable viral RNA
Measured: 14 days
Rate of mechanical ventilation
Measured: 14 days
Rate of ICU admission
Measured: 14 days
Time and rate of laboratory indicators related to disease improvement to return to normal
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start11 Feb 2020
- Primary completion13 Apr 2020
- Study completion13 Apr 2020
Why it stopped: There were no more subjects enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoVStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yunqing Qiu, Master, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261907
- Sponsor's protocol ID
- ASC09F-CTP-ZY-01
- Status last verified
- Feb 2020
- First submitted
- 6 Feb 2020
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection
- ClinicalTrials.gov ID
- NCT04261907
- Acronym / sponsor ID
- ASC09F-CTP-ZY-01
- Conditions
- 2019-nCoV
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were no more subjects enrolled.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 10 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.
Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASC09/ritonavir group | Experimental | Drug: ASC09/ritonavir groupASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment |
| lopinavir/ritonavir group | Active comparator | Drug: lopinavir/ritonavir groupLopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Aged between 18 and 75 years, extremes included, male or female
- 2. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"
- 3. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
- 4. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose
- 5. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
Key exclusion criteria (8 listed)
- 1. Severe 2019-nCoV pneumonia met one of the following criteria: respiratory distress, RR ≥ 30 times / min, or SaO2 / SpO2 ≤ 93% in resting state, or arterial partial pressure of oxygen (PaO2) /concentration of oxygen (FiO2) ≤ 300mmHg (1mmHg = 0.133kpa)
- 2. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment
- 3. Severe liver disease (e.g. Child Pugh score ≥ C, AST > 5 times upper limit)
- 4. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
- 5. Patients with definite contraindications in the label of ritonavir
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 |
|---|---|---|
| ASC09/ritonavir groupASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment | Drug | ASC09/ritonavir group |
| lopinavir/ritonavir groupLopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment | Drug | lopinavir/ritonavir group |
Primary outcome
The incidence of composite adverse outcome
Time frame: 14 days
Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.
9 secondary outcomes
Time to recovery
Time frame: 14 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 requring supplemental oxygen
Time frame: 14 days
Rate of undectable viral RNA
Time frame: 14 days
Rate of mechanical ventilation
Time frame: 14 days
Rate of ICU admission
Time frame: 14 days
Time and rate of laboratory indicators related to disease improvement to return to normal
Time frame: 14 days
Results and safety
The study was stopped early (reason given: There were no more subjects enrolled.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Yunqing Qiu, Master principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ASC09/ritonavir group and lopinavir/ritonavir group in people with 2019-nCoV, run by First Affiliated Hospital of Zhejiang University 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 8 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: stopped early, as of the sponsor's last update on 4 Apr 2022. 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.
Are results available for this study?
The study was stopped early (reason given: There were no more subjects enrolled.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of composite 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 4 Apr 2022.