Status:
COMPLETED
Severe Influenza Trial of ARbidol
Lead Sponsor:
Capital Medical University
Collaborating Sponsors:
University of Oxford
Peking University
Conditions:
Influenza
Eligibility:
All Genders
16+ years
Phase:
PHASE3
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 adult...
Eligibility Criteria
Inclusion
- Hospitalized males or females with a positive antigen or 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
- 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
Key Trial Info
Start Date :
January 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03787459
Start Date
January 18 2019
End Date
October 17 2024
Last Update
June 25 2025
Active Locations (1)
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1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029