NCT04261270

Brief Summary

Based on oseltamivir treatment, evaluate the efficacy and safety of ASC09/ritonavir compound tablets(ASC09F) or ritonavir tablets for 2019-nCoV infection patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2020

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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 1, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

February 4, 2020

Last Update Submit

March 14, 2020

Conditions

2019-nCoV Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Rate of comprehensive adverse outcome

    The definition of comprehensive adverse outcome is as follows: 1. SPO2≤93% without oxygen inhalation; 2. PaO2/FiO2≤300mmHg; 3. RR≥30 bpm without oxygen inhalation.

    14 days

Secondary Outcomes (9)

  • Time of clinical remission

    28 days

  • Rate of no fever

    14 days

  • Rate of no cough

    14 days

  • Rate of no dyspnea

    14 days

  • Rate of no need for oxygen inhalation

    14 days

  • +4 more secondary outcomes

Study Arms (3)

ASC09F+Oseltamivir

EXPERIMENTAL
Drug: ASC09F+Oseltamivir

Ritonavir+Oseltamivir

EXPERIMENTAL
Drug: Ritonavir+Oseltamivir

Oseltamivir

EXPERIMENTAL
Drug: Oseltamivir

Interventions

ASC09F+OseltamivirDRUG

ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day

ASC09F+Oseltamivir
Ritonavir+OseltamivirDRUG

Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day

Ritonavir+Oseltamivir
OseltamivirDRUG

75mg ,once a day

Oseltamivir

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age:18\~55 years old, unlimited gender.
  • Laboratory (RT-PCR) confirmed infection with 2019-nCoV and accompanied with clinical manifestations.
  • Patients with newly diagnosed respiratory discomfort who have been hospitalized (The proper diagnosis time is less than 7 days).
  • Women who have no planned pregnancy in the next six months,and are willing to take effective measures to prevent contraception from the first dose of study drug to 30 days after the last dose.
  • Agree not to participate in other clinical studies within 30 days from the first dose of the study drug to the last dose.
  • Patients who voluntarily sign informed consent forms.

You may not qualify if:

  • nCoV severe Pneumonia patients.
  • Meet the definition of severe pneumonia(Comply with any of the followings):
  • Respiratory distress ,RR≥30 bpm;
  • In a resting state:SPO2≤93%;
  • PaO2/ FiO2≤300mmHg.
  • nCoV critical and severe Pneumonia patients.Comply with any of the followings:Respiratory failure and need mechanical ventilation;Shock;Patients combined with other organ failure need ICU monitoring and treatment.
  • Severe liver disease(such as:the ChildPugh score≥C;AST \> 5 times the upper limit).
  • Patients who are allergic to the ingredients of ASC09/ritonavir compound tablets.
  • Patients with definite contraindications in ritonavir tablets.
  • Female subjects were positive for the pregnancy test during the screening period.
  • Researcher judges unsuitable for participation in this clinical trial(such as:during the study patients may be transferred to hospital for treatment;patients with multiple underlying diseases, etc)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department and Institute of Infectious Disease

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Central Study Contacts

Qing Ning, Professor

CONTACT

+8613971521450qning@vip.sina.com

Meifang Han, Professor

CONTACT

+8613986093605mfhan@foxmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 7, 2020

Study Start

February 1, 2020

Primary Completion

May 1, 2020

Study Completion

July 1, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

CN(1)