NCT04291729

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_4 covid19

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_4 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2020

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 2, 2020

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

April 13, 2020

Status Verified

March 1, 2020

Enrollment Period

1 month

First QC Date

February 27, 2020

Last Update Submit

April 9, 2020

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

    14 days

Secondary Outcomes (9)

  • Time to recovery

    14 days

  • Rate of no fever

    14 days

  • Rate of no cough

    14 days

  • Rate of no dyspnea

    14 days

  • Rate of no requiring supplemental oxygen

    14 days

  • +4 more secondary outcomes

Study Arms (1)

Ganovo+ritonavir with or without interferon nebulization

EXPERIMENTAL
Drug: Ganovo+ritonavir+/-Interferon nebulization

Interventions

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.

Ganovo+ritonavir with or without interferon nebulization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ninth Hospital of Nanchang

Nanchang, Jiangxi, 330000, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory 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

February 27, 2020

First Posted

March 2, 2020

Study Start

February 17, 2020

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

April 13, 2020

Record last verified: 2020-03

Locations

CN(1)