NCT04261907

Brief Summary

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

February 11, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2020

Completed
Last Updated

April 4, 2022

Status Verified

February 1, 2020

Enrollment Period

2 months

First QC Date

February 6, 2020

Last Update Submit

March 23, 2022

Conditions

2019-nCoV

Outcome Measures

Primary Outcomes (1)

  • The incidence of composite adverse outcome

    Defined as(one of them) SPO2≤ 93% without oxygen supplementation, PaO2/FiO2 ≤ 300mmHg or RR ≥ 30 breaths per.

    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 requring supplemental oxygen

    14 days

  • +4 more secondary outcomes

Study Arms (2)

ASC09/ritonavir group

EXPERIMENTAL

ASC09/ritonavir (300mg/100mg tablet)+conventional standardized treatment

Drug: ASC09/ritonavir group

lopinavir/ritonavir group

ACTIVE COMPARATOR

Lopinavir/ritonavir tablet (200mg / 50mg tablet)+conventional standardized treatment

Drug: lopinavir/ritonavir group

Interventions

ASC09/ritonavir groupDRUG

ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment

ASC09/ritonavir group
lopinavir/ritonavir groupDRUG

Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment

lopinavir/ritonavir group

Eligibility Criteria

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

You may qualify if:

  • \. Aged between 18 and 75 years, extremes included, male or female
  • \. Laboratory (RT-PCR) and clinical symptoms confirmed case of 2019-nCoV pneumonia, according to the official guideline "Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection (Trial Version 5)"
  • \. Hospitalised with a new onset respiratory illness (≤7 days since illness onset)
  • \. No family planning within six months, and agree to take effective contraceptive measures throughout the study and for at least 30 days after the final study drug dose
  • \. Must agree not to enroll in another study of an investigational agent prior to completion of Day 30 of study
  • \. Informed Consent Form (ICF) signed voluntarily

You may not qualify if:

  • \. Severe 2019-nCoV pneumonia met one of the following criteria: 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)
  • \. Critical severe 2019-nCoV pneumonia met one of the following criteria: respiratory failure and mechanical ventilation required, or shock, or combined with other organ failure required ICU monitoring treatment
  • \. Severe liver disease (e.g. Child Pugh score ≥ C, AST \> 5 times upper limit)
  • \. Known allergic reaction to any of components of ASC09 / ritonavir compound tablets
  • \. Patients with definite contraindications in the label of ritonavir
  • \. Positive serum pregnancy test result for women with childbearing potential at screening
  • \. Using HIV protease inhibitor drugs
  • \. Not suitable for the study, in the opinion of the Investigator (e.g. patient may be transferred to another hospital during the study period, patient with multiple basic diseases, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The first affiliated hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang Province, P.R. China, 310003, China

Location

MeSH Terms

Interventions

TMC-310911Lopinavir

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Yunqing Qiu, Master

    First Affiliated Hospital of Zhejiang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

February 11, 2020

Primary Completion

April 13, 2020

Study Completion

April 13, 2020

Last Updated

April 4, 2022

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)