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

NCT04345276 | Completed Phase 4

• 1 other identifier: ASC-CTP-HS-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• 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

  Within 10 days after administration

Secondary Outcomes (9)

• Time to recovery

  Within 10 days after administration

• Rate of no fever

  Within 10 days after administration

• Rate of no cough

  Within 10 days after administration

• Rate of no dyspnea

  Within 10 days after administration

• Rate of no requiring supplemental oxygen

  Within 10 days after administration

Study Arms (1)

Danoprevir+Ritonavir group

EXPERIMENTAL

Drug: Danoprevir+Ritonavir

Interventions

Danoprevir+Ritonavir DRUG

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.

Also known as: Ganovo

Danoprevir+Ritonavir group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Huoshenshan Hospital: lead
• Ascletis Pharmaceuticals Co., Ltd.: collaborator

Study Sites (1)

Huoshenshan Hostipal

Wuhan, Hubei, 430104, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Yahong Chen, MD

  Ascletis Pharmaceuticals Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 14, 2020
• Study Start: March 18, 2020
• Primary Completion: April 15, 2020
• Study Completion: April 15, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-03

Locations

CN (1)