InfluenzaPhase 3STARNCT03787459
Severe Influenza Trial of ARbidol
A Phase 3 study testing Arbidol in people with Influenza, run by Capital Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Arbidol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2019to 17 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
About this study
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
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.
- Conditions
- Influenza
- Being tested
- Arbidol, Placebos
- Keywords
- severe influenza, arbidol, oseltamivir, ordinal scale
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbidolDrug
Oseltamivir plus Arbidol will be administrated from Days 1-7.
PlacebosDrug
Oseltamivir plus placebos will be administrated from Days 1-7.
| Study group | Role | What they receive |
|---|---|---|
| oseltamivir plus placebo | Active comparator | Not described Receives: Drug: Placebos |
| oseltamivir plus arbidol | Experimental | Not described Receives: Drug: Arbidol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days
the event defined as seven-category ordinal scale of clinical status after enrolment decrease by two category or discharged
Measured: 28 days
Secondary outcomes (7)
Time to decline of one category on the seven-category ordinal scale of clinical status lasting for 48h, or hospital discharge within 28 days, days
the event defined as seven-category ordinal scale of clinical status after enrolment decrease by one category or discharged
Measured: Up to 28 days
Day 28 mortality rate
Measured: 28 days
Proportion of Clinical Improvement (≥2-category decline / discharge with improvement) at Days 7, 14, and 28 since arbidol initiation
Measured: Up to 28 days
Proportion of Patients at Each Category of the 7-category Ordinal Scale at Days 7, 14, and 28
Measured: up to 28 days
Duration of Mechanical Ventilation (days), Oxygen Therapy (days), Hospitalization (days), Time from Randomization to Discharge (days), Time from Randomization to Death (days)
Measured: Up to 28 days
Incidence of Secondary Infection, Secondary Aspergillus and Bacterial Infection
Measured: Up to 28 days
Patients Requiring Continuous Renal Replacement Therapy (CRRT) After Treatment
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start18 Jan 2019
- Primary completion9 Apr 2023
- Study completion17 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford, Peking University, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention
- Responsible party
- Principal investigator, Bin Cao, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787459
- Sponsor's protocol ID
- CAP-China Arbidol
- Acronym
- STAR
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2018
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03787459
- Acronym / sponsor ID
- STAR / CAP-China Arbidol
- Conditions
- Influenza
- Keywords
- severe influenza, arbidol, oseltamivir, ordinal scale
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- University of Oxford, Peking University, National Institute for Viral Disease Control and Prevention, Chinese Center for Disease Control and Prevention
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 17 Oct 2024 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oseltamivir plus placebo | Active comparator | Drug: Placebos |
| oseltamivir plus arbidol | Experimental | Drug: Arbidol |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArbidolOseltamivir plus Arbidol will be administrated from Days 1-7. | Drug | oseltamivir plus arbidol |
| PlacebosOseltamivir plus placebos will be administrated from Days 1-7. | Drug | oseltamivir plus placebo |
Primary outcome
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
7 secondary outcomes
Time to decline of one category on the seven-category ordinal scale of clinical status lasting for 48h, or hospital discharge within 28 days, days
Time frame: Up to 28 days
Day 28 mortality rate
Time frame: 28 days
Proportion of Clinical Improvement (≥2-category decline / discharge with improvement) at Days 7, 14, and 28 since arbidol initiation
Time frame: Up to 28 days
Proportion of Patients at Each Category of the 7-category Ordinal Scale at Days 7, 14, and 28
Time frame: up to 28 days
Duration of Mechanical Ventilation (days), Oxygen Therapy (days), Hospitalization (days), Time from Randomization to Discharge (days), Time from Randomization to Death (days)
Time frame: Up to 28 days
Incidence of Secondary Infection, Secondary Aspergillus and Bacterial Infection
Time frame: Up to 28 days
Patients Requiring Continuous Renal Replacement Therapy (CRRT) After Treatment
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Arbidol in people with Influenza, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint was time to clinical status improvement (the event) up to 28 days (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.