An Open Clinical Trial to Evaluate GanovoDanoprevir Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection
Latest Information Update: 31 Dec 2020
At a glance
- Drugs Danoprevir (Primary) ; Ritonavir (Primary) ; Interferon alpha
- Indications COVID-19 pneumonia; SARS-CoV-2 acute respiratory disease
- Focus Adverse reactions
- 25 Nov 2020 Results evaluating the safety and efficacy of of danoprevir boosted by ritonavir on treatment naive and experienced COVID-19 patients, published in the Medicine
- 24 Mar 2020 According to an Ascletis media release, data from this small-sample clinical study was published in medRxiv.
- 24 Mar 2020 Results presented in an Ascletis media release.
Most Recent Events
Trial Overview
Purpose
Evaluation of the efficacy and safety of Ganovo combined with ritonavir for patients infected with SARS-CoV-2.
Primary Endpoints
Rate of composite adverse outcomes
description: Defined as SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤300mmHg or a respiratory rate ≥30 breaths per min without supplemental oxygen
time_frame: 14 days
Other Endpoints
Time to recovery
description: 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).
time_frame: 14 days
Rate of no fever
description: Rate of no fever
time_frame: 14 days
Rate of no cough
description: Rate of no cough
time_frame: 14 days
Rate of no dyspnea
description: Rate of no dyspnea
time_frame: 14 days
Rate of no requiring supplemental oxygen
description: Rate of no requiring supplemental oxygen
time_frame: 14 days
Rate of undetectable New coronavirus pathogen nucleic acid
description: Rate of undetectable New coronavirus pathogen nucleic acid
time_frame: 14 days
Rate of mechanical ventilation
description: Rate of mechanical ventilation
time_frame: 14 days
Rate of ICU admission
description: Rate of ICU admission
time_frame: 14 days
Rate of serious adverse event
description: Rate of serious adverse event
time_frame: 14 days [1]
Diseases Treated
Indication | Qualifiers | Patient Segments |
---|---|---|
COVID-19 pneumonia | treatment | moderate |
SARS-CoV-2 acute respiratory disease | treatment | moderate |
Subjects
- Subject Type patients
-
Number
Planned: 50
Actual: 11
- Sex male & female
- Age Group 18-75 years (mean age 44 years; range18-66); adult; elderly
Patient Inclusion Criteria
- 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.
Patient Exclusion Criteria
- 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 Details
Identifiers
Identifier | Owner |
---|---|
NCT04291729 | ClinicalTrials.gov: US National Institutes of Health |
ASC-CTP-NC01 | - |
Organisations
- Affiliations Ascletis
Trial Dates
-
Initiation Dates
Actual : 17 Feb 2020
-
Primary Completion Dates
Planned : 31 Mar 2020
Actual : 19 Mar 2020
-
End Dates
Planned : 30 Apr 2020
Actual : 19 Mar 2020
Other Details
- Design open; prospective
- Phase of Trial Phase IV
- Location China
- Focus Adverse reactions
Interventions
Drugs | Route | Formulation |
---|---|---|
DanoprevirPrimary Drug | Oral | Tablet |
Interferon alpha | Inhalation | Spray |
RitonavirPrimary Drug | Oral | Tablet |
Ganovo+ritonavir with or without interferon nebulization
Drug: Ganovo+ritonavir+/-Interferon nebulization (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.)
Results
Therapeutic efficacy
Clinical: Results from a clinical study for danoprevir in treatment of COVID-2019 demonstrated normal body temperature for at least 3 days, significantly improved respiratory symptoms, lung imaging showing obvious absorption and recovery of acute exudative lesion; and two consecutive RT-PCR negative tests of SARS-CoV-2 nucleotide acid (respiratory track sampling with interval at least one day). After initiation of danoprevir/ritonavir treatment, the first negative RT-PCR test occurred at a median of two days, ranging from one to eight days, and the obvious absorption in CT scans occurred at a median three days, ranging from two to four days. The trial enrolled eleven patients [2] .
Adverse events
Clinical: Results from a clinical study for danoprevir for treatment of COVID-2019 demonstrated safety and was well tolerated. The trial enrolled eleven patients [2] .
Publications
-
Ascletis. Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients. Media-Rel 2020;.
Media Release -
Chen H, Zhang Z, Wang L, Huang Z, Gong F, Li X, et al. First clinical study using HCV protease inhibitor danoprevir to treat COVID-19 patients. Medicine 2020;99(48):e23357.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
Investigator | Centre Name | Trial Centre Country |
---|---|---|
Hongyi Chen, MD
8613807088660
show details
Chenhongyi8660@163.com |
-
|
|
Yahong Chen, MD | Ascletis Pharmaceuticals Co., Ltd. |
-
|
Zhicheng Zhang, MD
86130779422733
show details
zzc925219@163.com |
The Ninth Hospital of Nanchang | China |
Centres
Centre Name | Location | Trial Centre Country |
---|---|---|
- |
-
|
-
|
Ascletis Pharmaceuticals Co., Ltd. |
-
|
-
|
The Ninth Hospital of Nanchang |
-
|
-
|
The Ninth Hospital of Nanchang | Nanchang, Jiangxi | China |
Trial History
Event Date | Event Type | Comment |
---|---|---|
25 Nov 2020 | Results | Results evaluating the safety and efficacy of of danoprevir boosted by ritonavir on treatment naive and experienced COVID-19 patients, published in the Medicine Updated 31 Dec 2020 |
14 Apr 2020 | Other trial event | Last checked against ClinicalTrials.gov record. Updated 14 Apr 2020 |
24 Mar 2020 | Results | According to an Ascletis media release, data from this small-sample clinical study was published in medRxiv. Updated 27 Mar 2020 |
24 Mar 2020 | Results | Results presented in an Ascletis media release. Updated 27 Mar 2020 |
20 Mar 2020 | Status change - completed | Status changed from recruiting to completed. Updated 26 Mar 2020 |
10 Mar 2020 | Other trial event | According to an Ascletis media release, a group of 11 patients receiving oral Ganovo and Ritonavir combination therapy have been discharged from the hospital as they are satisfied with the discharge standards under the Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6) issued by the National Health Commission of the People's Republic of China. Updated 12 Mar 2020 |
05 Mar 2020 | Other trial event | New source identified and integrated: (ClinicalTrials.gov: US National Institutes of Health: NCT04291729). Updated 05 Mar 2020 |
02 Mar 2020 | New trial record | New trial record Updated 02 Mar 2020 |
26 Feb 2020 | Other trial event | According to an Ascletis media release, On February 16, 2020, the clinical trial obtained approval from the ethics committee of the Ninth Hospital of Nanchang. The first patient diagnosed with the Novel Coronavirus Pneumonia was enrolled for the treatment of Ganovo and Ritonavir combination therapy on February 17, 2020. Updated 02 Mar 2020 |
26 Feb 2020 | Other trial event | According to an Ascletis media release, three patients have been discharged from the hospital after such treatment as they are satisfied with the discharge standards under the "Diagnosis and Treatment Program for Novel Coronavirus Infection (Trial Version 6) issued by the National Health Commission of the People's Republic of China, and other enrolled patients are being treated. Updated 02 Mar 2020 |
26 Feb 2020 | Other trial event | According to an Ascletis media release, this trial is led by Dr. Hongyi CHEN, the director of the Ninth Hospital of Nanchang. Updated 02 Mar 2020 |
Table of Contents
References
-
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
Available from: URL: http://clinicaltrials.gov -
Ascletis. Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients. Media-Rel 2020;.
Media Release -
Ascletis. Clinical Trial of Ganovo(R)and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia. Media-Rel 2020;.
Media Release -
Chen H, Zhang Z, Wang L, Huang Z, Gong F, Li X, et al. First clinical study using HCV protease inhibitor danoprevir to treat COVID-19 patients. Medicine 2020;99(48):e23357.
PubMed | CrossRef Fulltext -
Ascletis. Progress of the Small Sample Clinical Trial of Ganovo(Rm) and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia. Media-Rel 2020;.
Media Release
Adis International Ltd. Part of Springer Science+Business Media
© Springer Nature Switzerland AG