STAR: Severe Influenza Trial of ARbidol

• Sponsor: Capital Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03787459
• Collaborator: University of Oxford (Other), Peking University (Other), National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention (Other)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.4
• Patients Per Site Per Month: 10.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: Arbidol; Drug: Placebos	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jan 18, 2019
• Anticipated Primary Completion Date: Mar 30, 2020
• Anticipated Study Completion Date: Aug 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: oseltamivir plus placebo	Drug: Placebos; Oseltamivir plus placebos will be administrated from Days 1-7.
Experimental: oseltamivir plus arbidol	Drug: Arbidol; Oseltamivir plus Arbidol will be administrated from Days 1-7.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Hospitalized males or females with a positive PCR test for influenza virus infection

2. Age ≥16 years at the time of signing Informed Consent Form

3. Arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) ≤94% in room air condition

4. ≤ 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.

5. Willingness to use contraception for 7 days after the end of treatment

Exclusion Criteria:

1. 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.

2. Patient refusal to accept invasive organ support treatment if needed

3. More than 3 consecutive doses of NAIs within 2 days before enrolment (including oseltamivir, zanamivir, peramivir)

4. 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.

1. Any condition requiring renal replacement therapy

2. Severe liver disease (Child-Pugh score ≥ C)

3. A history of hypersensitivity to arbidol or oseltamivir (Tamiflu®)

4. Currently or have been involved in another anti-influenza treatment trial in the last 28 days

5. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	China-Japan Friendship Hospital	Beijing	Beijing	China	100029

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bin Cao, China-Japan Friendship Hospital, Capital Medical University
• ClinicalTrials.gov Identifier: NCT03787459
• Other Study ID Numbers: CAP-China Arbidol
• First Posted: Dec 26, 2018
• Last Update Posted: Jan 18, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bin Cao, China-Japan Friendship Hospital, Capital Medical University: severe influenza, arbidol, oseltamivir, ordinal scale
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Jan 18, 2019