Severe Influenza Trial of ARbidol (STAR)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03787459|
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : January 18, 2019
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||January 18, 2019|
|Estimated Primary Completion Date :||March 30, 2020|
|Estimated Study Completion Date :||August 1, 2020|
|Active Comparator: oseltamivir plus placebo||
Oseltamivir plus placebos will be administrated from Days 1-7.
|Experimental: oseltamivir plus arbidol||
Oseltamivir plus Arbidol will be administrated from Days 1-7.
- The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days [ Time Frame: 28 days ]the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03787459
|China-Japan Friendship Hospital||Recruiting|
|Beijing, Beijing, China, 100029|
|Contact: Bin Cao, MD +8684206264 email@example.com|
|Contact: Yeming Wang, MD +8618810663558 firstname.lastname@example.org|