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Trial record 82 of 118 for:    oseltamivir

Severe Influenza Trial of ARbidol (STAR)

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ClinicalTrials.gov Identifier: NCT03787459
Recruitment Status : Recruiting
First Posted : December 25, 2018
Last Update Posted : January 18, 2019
Sponsor:
Collaborators:
University of Oxford
Peking University
National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention
Information provided by (Responsible Party):
Bin Cao, Capital Medical University

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 18, 2019
Estimated Primary Completion Date : March 30, 2020
Estimated Study Completion Date : August 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir

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.




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  5. Any condition requiring renal replacement therapy
  6. Severe liver disease (Child-Pugh score ≥ C)
  7. A history of hypersensitivity to arbidol or oseltamivir (Tamiflu®)
  8. Currently or have been involved in another anti-influenza treatment trial in the last 28 days
  9. Patients who, in the opinion of the investigator, would be unlikely to comply with required study visits, self-assessments, and interventions

Information from the National Library of Medicine

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


Locations
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China, Beijing
China-Japan Friendship Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: Bin Cao, MD    +8684206264    caobin_ben@163.com   
Contact: Yeming Wang, MD    +8618810663558    wwyymm_love@163.com   
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

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Responsible Party: Bin Cao, China-Japan Friendship Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT03787459     History of Changes
Other Study ID Numbers: CAP-China Arbidol
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bin Cao, Capital Medical University:
severe influenza, arbidol, oseltamivir, ordinal scale
Additional relevant MeSH terms:
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Oseltamivir
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action