Phase
Condition
Influenza
Treatment
Placebos
Arbidol
Clinical Study ID
Ages > 16 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Hospitalized males or females with a positive antigen or PCR test for influenzavirus infection
Age ≥16 years at the time of signing Informed Consent Form
Arterial oxygen saturation (SaO2)/ pulse oxygen saturation (SPO2) ≤94% in room aircondition
≤ 7 days since symptom onset. The onset of symptoms is defined as either: Time ofthe first increase in body temperature (an increase of at least 1ºC from normal bodytemperature- ≥38℃); Time when the patient experiences at least one general orrespiratory symptom.
Willingness to use contraception for 7 days after the end of treatment
Exclusion
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 (includingoseltamivir, 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 ormore and confirmed by a follicle-stimulating hormone test) women. b. Women who aresurgically 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 thelast 28 days
Patients who, in the opinion of the investigator, would be unlikely to comply withrequired study visits, self-assessments, and interventions
Study Design
Connect with a study center
China-Japan Friendship Hospital
Beijing, Beijing 100029
ChinaSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.