COVID-19Phase 4NCT04345276

Efficacy and Safety of Ganovo (Danoprevir) Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

A Phase 4 study testing Danoprevir+Ritonavir in people with COVID-19, run by Huoshenshan Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients. 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?: Danoprevir+Ritonavir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteChina
Study dates: 18 Mar 2020to 15 Apr 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 SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 SARS-CoV-2 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 danoprevir and ritonavir tablets;
Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.
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.

China1 site

Huoshenshan Hostipal
Wuhan, Hubei, 430104

Other trials in China

About this study

Official title: An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Evaluation of the efficacy and safety of Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.

Read the detailed description

Given no specific antiviral therapies for COVID-19 approved yet and Danoprevir sodium tablet, an oral Hepatitis C virus protease inhibitor, approved in China in June 2018 , this open, controlled trial will evaluate the efficacy and safety of Danoprevir sodium tablet in hospitalized patients infected with SARS-CoV-2.

Conditions: COVID-19
Being tested: Danoprevir+Ritonavir
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Danoprevir+RitonavirDrug
Also called Ganovo
Danoprevir 100mg , one tablet each time , twice per day, up to 10 days. Ritonavir 100mg, one tablet each time , twice per day, up to 10 days.

Study groups in NCT04345276
Study group	Role	What they receive
Danoprevir+Ritonavir group	Experimental	Not described Receives: Drug: Danoprevir+Ritonavir

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 min without supplemental oxygen
Measured: Within 10 days after administration

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 ≥ 30 breaths per min without supplemental oxygen).
Measured: Within 10 days after administration
Rate of no fever
Measured: Within 10 days after administration
Rate of no cough
Measured: Within 10 days after administration
Rate of no dyspnea
Measured: Within 10 days after administration
Rate of no requiring supplemental oxygen
Measured: Within 10 days after administration
Rate of undetectable New coronavirus pathogen nucleic acid
Measured: Within 10 days after administration
Rate of mechanical ventilation
Measured: Within 10 days after administration
Rate of ICU admission
Measured: Within 10 days after administration
Rate of serious adverse event
Measured: Within 10 days after administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Mar 202015 Apr 2020

First posted14 Apr 2020
Study start18 Mar 2020
Primary completion15 Apr 2020
Study completion15 Apr 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: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04345276
Sponsor's protocol ID: ASC-CTP-HS-01
Status last verified: Mar 2020
First submitted: 10 Apr 2020
Last updated: 2 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Clinical Trial to Evaluate Danoprevir Sodium Tablets Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
ClinicalTrials.gov ID: NCT04345276
Acronym / sponsor ID: ASC-CTP-HS-01
Conditions: COVID-19
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Huoshenshan HospitalUniversity, hospital or other
Collaborators: Ascletis Pharmaceuticals Co., Ltd.
Study start: 18 Mar 2020 (actual)
Primary completion: 15 Apr 2020 (actual)
Study completion: 15 Apr 2020 (actual)
First posted: 14 Apr 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 Danoprevir sodium tablet combined with ritonavir for SARS-CoV-2 infected patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Danoprevir+Ritonavir group	Experimental	Drug: Danoprevir+Ritonavir

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 SARS-CoV-2 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 SARS-CoV-2 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 (7 listed)

The pneumonia patients with severe SARS-CoV-2 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 SARS-CoV-2 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 danoprevir and ritonavir tablets;
Patients who plan to take protease inhibitors other than danoprevir and ritonavir simultaneously during the trial.

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
Danoprevir+RitonavirAlso: GanovoDanoprevir 100mg , one tablet each time , twice per day, up to 10 days. Ritonavir 100mg, one tablet each time , twice per day, up to 10 days.	Drug	Danoprevir+Ritonavir group

Primary outcome

Rate of composite adverse outcomes
Time frame: Within 10 days after administration
Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen min without supplemental oxygen

9 secondary outcomes

Time to recovery
Time frame: Within 10 days after administration
Rate of no fever
Time frame: Within 10 days after administration
Rate of no cough
Time frame: Within 10 days after administration
Rate of no dyspnea
Time frame: Within 10 days after administration
Rate of no requiring supplemental oxygen
Time frame: Within 10 days after administration
Rate of undetectable New coronavirus pathogen nucleic acid
Time frame: Within 10 days after administration
Rate of mechanical ventilation
Time frame: Within 10 days after administration
Rate of ICU admission
Time frame: Within 10 days after administration
Rate of serious adverse event
Time frame: Within 10 days after administration

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 2 Jun 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 Danoprevir+Ritonavir in people with COVID-19, run by Huoshenshan 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 7 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 2 Jun 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: Within 10 days after administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04345276.

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 2 Jun 2020.