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Severe Influenza Trial of ARbidol (STAR)

Primary Purpose

Influenza

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Arbidol

Placebos

About this trial

This is an interventional treatment trial for Influenza focused on measuring severe influenza, arbidol, oseltamivir, ordinal scale

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Hospitalized males or females with a positive PCR test for influenza virus infection
Age ≥16 years at the time of signing Informed Consent Form
Arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) ≤94% in room air condition
≤ 7 days since symptom onset. The onset of symptoms is defined as either: Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature- ≥38℃); Time when the patient experiences at least one general or respiratory symptom.
Willingness to use contraception for 7 days after the end of treatment

Exclusion Criteria:

Physicians make a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
Patient refusal to accept invasive organ support treatment if needed
More than 3 consecutive doses of NAIs within 2 days before enrolment (including oseltamivir, zanamivir, peramivir)
Women who are pregnant (including a positive pregnancy test at enrolment), breastfeeding, or within 2 weeks post-partum.
The following female subjects do not need to undergo a pregnancy test at enrolment: a. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women. b. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation.
Any condition requiring renal replacement therapy
Severe liver disease (Child-Pugh score ≥ C)
A history of hypersensitivity to arbidol or oseltamivir (Tamiflu®)
Currently or have been involved in another anti-influenza treatment trial in the last 28 days
Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Sites / Locations

China-Japan Friendship HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

oseltamivir plus placebo

oseltamivir plus arbidol

Arm Description

Outcomes

Primary Outcome Measures

The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days

the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged

Secondary Outcome Measures

Full Information

NCT ID

NCT03787459

First Posted

December 22, 2018

Last Updated

January 17, 2019

Sponsor

Capital Medical University

Collaborators

University of Oxford, Peking University, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention

1. Study Identification

Unique Protocol Identification Number

NCT03787459

Brief Title

Severe Influenza Trial of ARbidol

Acronym

STAR

Official Title

Oseltamivir and Arbidol Combination Antiviral Therapy Versus Oseltamivir Monotherapy for the Treatment of Severe inﬂuenza: a Multicentre, Double-blind, Randomised Phase 3 Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 18, 2019 (Actual)

Primary Completion Date

March 30, 2020 (Anticipated)

Study Completion Date

August 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Capital Medical University

Collaborators

University of Oxford, Peking University, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a multicenter, randomised, double-blind, controlled study to assess the efficacy and safety of arbidol plus oseltamivir, compared with oseltamivir alone in approximately 200 hospitalized adults and adolescent patients with confirmed severe influenza. Patients should be randomised as soon as possible after screening (no later than 12 hours), providing they are within 7 days of symptom onset. Patients will be assigned in a 1:1 ratio to receive an arbidol plus oseltamivir, or oseltamivir plus placebo. Rescreening of patients who fail to meet the inclusion and exclusion criteria will be permitted only once, providing the time from symptom onset to randomization is still within 7 days. Arbidol/placebo will be administrated as 200mg TID from Days 1-7. Oseltamivir will be administered as 75mg twice daily from Days 1-7 (dose to be adjusted for renal impairment). Oseltamivir could be continued till influenza PCR negative. Both drugs, along with the corresponding placebo for arbidol, will be started at the time of randomization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

severe influenza, arbidol, oseltamivir, ordinal scale

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

oseltamivir plus placebo

Arm Type

Active Comparator

Arm Title

oseltamivir plus arbidol

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Arbidol

Intervention Description

Oseltamivir plus Arbidol will be administrated from Days 1-7.

Intervention Type

Drug

Intervention Name(s)

Placebos

Intervention Description

Oseltamivir plus placebos will be administrated from Days 1-7.

Primary Outcome Measure Information:

Title

The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days

Description

the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hospitalized males or females with a positive PCR test for influenza virus infection Age ≥16 years at the time of signing Informed Consent Form Arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) ≤94% in room air condition ≤ 7 days since symptom onset. The onset of symptoms is defined as either: Time of the first increase in body temperature (an increase of at least 1ºC from normal body temperature- ≥38℃); Time when the patient experiences at least one general or respiratory symptom. Willingness to use contraception for 7 days after the end of treatment Exclusion Criteria: Physicians make a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely. Patient refusal to accept invasive organ support treatment if needed More than 3 consecutive doses of NAIs within 2 days before enrolment (including oseltamivir, zanamivir, peramivir) Women who are pregnant (including a positive pregnancy test at enrolment), breastfeeding, or within 2 weeks post-partum. The following female subjects do not need to undergo a pregnancy test at enrolment: a. Postmenopausal (defined as cessation of regular menstrual periods for 2 years or more and confirmed by a follicle-stimulating hormone test) women. b. Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation. Any condition requiring renal replacement therapy Severe liver disease (Child-Pugh score ≥ C) A history of hypersensitivity to arbidol or oseltamivir (Tamiflu®) Currently or have been involved in another anti-influenza treatment trial in the last 28 days Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Facility Information:

Facility Name

China-Japan Friendship Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bin Cao, MD

Phone

+8684206264

caobin_ben@163.com

First Name & Middle Initial & Last Name & Degree

Yeming Wang, MD

Phone

+8618810663558

wwyymm_love@163.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand. Best

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Severe Influenza Trial of ARbidol

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