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An Open Clinical Trial to Evaluate GanovoDanoprevir Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Trial Profile

An Open Clinical Trial to Evaluate GanovoDanoprevir Combined With Ritonavir in the Treatment of SARS-CoV-2 Infection

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 14 Apr 2020

At a glance

  • Drugs Danoprevir (Primary) ; Ritonavir (Primary) ; Interferon
  • Indications COVID 2019 infections
  • Focus Adverse reactions
  • Most Recent Events

    • 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.
    • 20 Mar 2020 Status changed from recruiting to completed.

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 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 50

    Actual: 11

  • Sex male & female
  • Age Group 18-75 years; 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 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

  1. Ascletis. Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients. Media-Rel 2020;.

    Media Release

Authors

Author Total Publications First Author Last Author
Ascletis 1 1 1

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Hongyi Chen, MD
8613807088660
Chenhongyi8660@163.com
show details
-
Yahong Chen, MD Ascletis Pharmaceuticals Co., Ltd.
-
Zhicheng Zhang, MD
86130779422733
zzc925219@163.com
show details
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
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

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
  2. Ascletis. Results from First Clinical Study Using Danoprevir to Treat Naive and Experienced COVID-19 Patients. Media-Rel 2020;.

    Media Release
  3. Ascletis. Clinical Trial of Ganovo(R)and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia. Media-Rel 2020;.

    Media Release
  4. Ascletis. Progress of the Small Sample Clinical Trial of Ganovo(Rm) and Ritonavir Combination Therapy on Novel Coronavirus Pneumonia. Media-Rel 2020;.

    Media Release
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