COVID-19Phase 4NCT04291729
Evaluation of Ganovo （Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
A Phase 4 study testing Ganovo+ritonavir+/-Interferon nebulization in people with COVID-19, run by The Ninth Hospital of Nanchang at 1 site in China.
Trial summary
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Ganovo+ritonavir+/-Interferon nebulization
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteChina
- Study dates
- 17 Feb 2020to 19 Mar 2020
- Phase
- Phase 4
- 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
- Aged 18-75 years old;
- Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (Current Trial Version);
- Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
- Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
- Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
- Patients who voluntarily sign informed consent.
Who cannot join
- The pneumonia patients with severe new coronavirus infection met one of the following conditions: 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);
- Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
- Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit);
- Patients with contraindications specified in the instructions of ritonavir tablets;
- The pregnancy test of female subjects in the screening period was positive;
- The researchers judged that it was not suitable to participate in this clinical trial (for example, patients who may be transferred to another hospital during the study period; patients with multiple basic diseases, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Clinical Trial to Evaluate Ganovo（Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Read the detailed description
Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.
- Conditions
- COVID-19
- Being tested
- Ganovo+ritonavir+/-Interferon nebulization
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ganovo+ritonavir+/-Interferon nebulizationDrug
Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Ganovo+ritonavir with or without interferon nebulization | Experimental | Not described Receives: Drug: Ganovo+ritonavir+/-Interferon nebulization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of composite adverse outcomes
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
Measured: 14 days
Secondary outcomes (9)
Time to recovery
Clinical recovery was defined as 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).
Measured: 14 days
Rate of no fever
Rate of no fever
Measured: 14 days
Rate of no cough
Rate of no cough
Measured: 14 days
Rate of no dyspnea
Rate of no dyspnea
Measured: 14 days
Rate of no requiring supplemental oxygen
Rate of no requiring supplemental oxygen
Measured: 14 days
Rate of undetectable New coronavirus pathogen nucleic acid
Rate of undetectable New coronavirus pathogen nucleic acid
Measured: 14 days
Rate of mechanical ventilation
Rate of mechanical ventilation
Measured: 14 days
Rate of ICU admission
Rate of ICU admission
Measured: 14 days
Rate of serious adverse event
Rate of serious adverse event
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 posted2 Mar 2020
- Study start17 Feb 2020
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Ninth Hospital of Nanchang
- Sponsor type
- University, hospital or other
- Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yahong Chen, MD, Study director, Ascletis Pharmaceuticals Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04291729
- Sponsor's protocol ID
- ASC-CTP-NC-01
- Status last verified
- Mar 2020
- First submitted
- 27 Feb 2020
- Last updated
- 13 Apr 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 13 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Clinical Trial to Evaluate Ganovo（Danoprevir ） Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
- ClinicalTrials.gov ID
- NCT04291729
- Acronym / sponsor ID
- ASC-CTP-NC-01
- Conditions
- COVID-19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- The Ninth Hospital of NanchangUniversity, hospital or other
- Collaborators
- Ascletis Pharmaceuticals Co., Ltd.
- Study start
- 17 Feb 2020 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 2 Mar 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.
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Detailed description
Given no specific antiviral therapies for new coronavirus pneumonia approved yet and Ganovo, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Ganovo in hospitalized patients infected with SARS-CoV-2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ganovo+ritonavir with or without interferon nebulization | Experimental | Drug: Ganovo+ritonavir+/-Interferon nebulization |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18-75 years old;
- Pneumonia patients with new coronavirus infection were confirmed to be positive by RT-PCR and clinical manifestations. The diagnosis standard refers to the diagnosis and treatment plan for pneumonia with new coronavirus infection (Current Trial Version);
- Patients with newly diagnosed respiratory system discomfort who have been hospitalized (the diagnosis time of respiratory system discomfort shall not exceed 7 days);
- Women and their partners who have no planned pregnancy for nearly half a year and are willing to take effective contraceptive measures within 30 days from the first administration of the study drug to the last administration;
- Agree not to participate in other clinical research within 30 days from the first administration of the study drug to the last administration;
Key exclusion criteria (6 listed)
- The pneumonia patients with severe new coronavirus infection met one of the following conditions: 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);
- Pneumonia patients with severe new coronavirus infection meet one of the following conditions: respiratory failure and need mechanical ventilation; or shock; or other organ failure combined with ICU monitoring treatment;
- Severe liver disease (such as child Pugh score >=C, AST > 5 times upper limit);
- Patients with contraindications specified in the instructions of ritonavir tablets;
- The pregnancy test of female subjects in the screening period was positive;
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 |
|---|---|---|
| Ganovo+ritonavir+/-Interferon nebulizationGanovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days. | Drug | Ganovo+ritonavir with or without interferon nebulization |
Primary outcome
Rate of composite adverse outcomes
Time frame: 14 days
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
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 requiring supplemental oxygen
Time frame: 14 days
Rate of undetectable New coronavirus pathogen nucleic acid
Time frame: 14 days
Rate of mechanical ventilation
Time frame: 14 days
Rate of ICU admission
Time frame: 14 days
Rate of serious adverse event
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 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.
Yahong Chen, MD study director
Ascletis Pharmaceuticals Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ganovo+ritonavir+/-Interferon nebulization in people with COVID-19, run by The Ninth Hospital of Nanchang 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 6 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: finished, as of the sponsor's last update on 13 Apr 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of composite adverse outcomes (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 13 Apr 2020.