InfluenzaPhase 2/3COMBO 1NCT04327791
COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)
A Phase 2/3 study testing Baloxavir in people with Influenza, run by Bassett Healthcare at 3 sites in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- Baloxavir
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 3 Apr 2020to 1 Oct 2024
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults >/= 18 years old
- Laboratory confirmed influenza A and/or B (rapid test or PCR)
- Able to be enrolled, randomized, and dosed with study drug within 8 hours of the decision to admit patient to hospital for treatment of influenza
- Oseltamivir treatment ordered by clinical team AND patient is able to be enrolled:
- Prior to the initial dose of oseltamivir OR
- Within 60 minutes after the initial dose of oseltamivir
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- Subject or Legally Authorized Representative able to and willing to provide written informed consent
- Able to commit to 30 days of follow up
- Weight > 40 kg
- SARS-CoV-2 PCR swab sent within 1 week of enrollment
Who cannot join
- ESRD not undergoing hemodialysis (HD) or peritoneal dialysis (CAPD)
- Severe hepatic insufficiency, cirrhosis, acute or chronic liver failure
- Nausea/vomiting, aspiration risk, or other conditions precluding the ability to use oral medications (if patient is NPO including meds, otherwise unable to swallow oral medications)
- Influenza medication use within the prior week, other than the initial oseltamivir given during this hospitalization for this episode of influenza
- Oseltamivir or baloxavir allergy or intolerance
- Pregnancy (need negative pregnancy test (urine or blood) in reproductive age women)
Show all 9Show fewer
- Absence of dependable contraception in reproductive age women
- Inability to obtain informed consent
- Refusal of oseltamivir therapy by patient as baseline treatment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Bassett Medical Center
Cooperstown, New York, 13326
Oregon Health & Science University
Portland, Oregon, 97239
Baystate Medical Center
Springfield, Massachusetts, 01199
About this study
This is a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
Read the detailed description
Up to 60 hospitalized patients with laboratory confirmed influenza who provide informed consent and meet trial inclusion/exclusion criteria.
Experimental Design and Methods In a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial, hospitalized patients with laboratory confirmed influenza meeting inclusion and exclusion criteria, will be provided information on the trial, offered enrollment, and enrolled randomly in a 1:1 ratio to one of two groups upon signing of the study's informed consent form: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
- Group 1, the combination treatment group will receive oseltamivir and baloxavir
- Oseltamivir: 75 mg po bid for 5 days
- Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg
- Group 2, the standard treatment group will receive oseltamivir and placebo
- Oseltamivir: 75 mg po bid for 5 days
- Placebo: Once
Oseltamivir dosing may be reduced for patients with decreased renal function as follows, per treating physician:
- CrCl > 60 mL/minute: No dosage adjustment
- CrCl > 30 to 60 mL/minute: 30 mg po bid
- CrCl > 10 to 30 mL/minute: 30 mg po qd
- HD: 30 mg po once and 30 mg po after each HD session
- CAPD: 30 mg po once
- CRRT: 30 mg po qd After assignment of a unique study number after signing informed consent, baseline data will be collected at time 0 including personal and clinical information and protocol directed laboratory specimens - nasal swabs for influenza PCR for patients who only had a rapid antigen test and blood specimens for patients who consent to additional blood drawing (for improved efficacy and safety analyses; not required for enrollment). Patients will be given oseltamivir by their healthcare providers. Research personnel's only involvement for oseltamivir dosing will be to remind providers that earlier treatment improves efficacy. Patients will then be given a single dose of baloxavir or placebo by the study's CRC as per a computerized random allocation scheme with dose determined by weight (as above); the CRC will notify the patient's provider that the patient has been given the single (blinded) dose. At time 1, 2, 3, 4, 7, and 30 days, nasal swabs will again be obtained, clinical information will be obtained from the patient via interview and review of the EMR, and blood specimens for patients who consented to additional blood drawing. Follow up will continue for 30 days.
Efficacy and adjudicated safety data points will be assessed by a Data Monitoring Committee (DMC) quarterly and as needed throughout the trial.
- Conditions
- Influenza
- Being tested
- Baloxavir, Placebos
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaloxavirDrug
administered PO once
PlacebosDrug
administered PO once
| Study group | Role | What they receive |
|---|---|---|
| baloxavir | Experimental | Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg Receives: Drug: Baloxavir |
| placebo | Placebo comparator | placebo po once Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clearance of Viral Shedding
influenza viral titer obtained by nasal swab using qCulture
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start3 Apr 2020
- Primary completion3 Jul 2024
- Study completion1 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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bassett Healthcare
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc., Viroclinics Biosciences B.V.
- Responsible party
- Principal investigator, Daniel Freilich, MD, Bassett Healthcare
- Investigators
- Daniel Freilich, MD, Principal investigator, Bassett Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327791
- Sponsor's protocol ID
- 1579493
- Acronym
- COMBO 1
- Status last verified
- May 2026
- First submitted
- 27 Mar 2020
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COmbination Therapy With Baloxavir and Oseltamivir 1 for Hospitalized Patients With Influenza (The COMBO Trial 1)
- ClinicalTrials.gov ID
- NCT04327791
- Acronym / sponsor ID
- COMBO 1 / 1579493
- Conditions
- Influenza
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bassett HealthcareUniversity, hospital or other
- Collaborators
- Genentech, Inc., Viroclinics Biosciences B.V.
- Study start
- 3 Apr 2020 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 31 Mar 2020 (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 randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial of hospitalized patients with laboratory confirmed influenza. Eligible and consented patients will be randomly assigned, in a 1:1 ratio, to one of two groups: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
Detailed description
Up to 60 hospitalized patients with laboratory confirmed influenza who provide informed consent and meet trial inclusion/exclusion criteria.
Experimental Design and Methods In a randomized, double-blind, placebo-controlled Phase 2-like, investigator-directed trial, hospitalized patients with laboratory confirmed influenza meeting inclusion and exclusion criteria, will be provided information on the trial, offered enrollment, and enrolled randomly in a 1:1 ratio to one of two groups upon signing of the study's informed consent form: Group 1, the combination treatment group (oseltamivir and baloxavir); Group 2, the standard treatment group (oseltamivir and placebo).
- Group 1, the combination treatment group will receive oseltamivir and baloxavir
- Oseltamivir: 75 mg po bid for 5 days
- Baloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg
- Group 2, the standard treatment group will receive oseltamivir and placebo
- Oseltamivir: 75 mg po bid for 5 days
- Placebo: Once
Oseltamivir dosing may be reduced for patients with decreased renal function as follows, per treating physician:
- CrCl > 60 mL/minute: No dosage adjustment
- CrCl > 30 to 60 mL/minute: 30 mg po bid
- CrCl > 10 to 30 mL/minute: 30 mg po qd
- HD: 30 mg po once and 30 mg po after each HD session
- CAPD: 30 mg po once
- CRRT: 30 mg po qd After assignment of a unique study number after signing informed consent, baseline data will be collected at time 0 including personal and clinical information and protocol directed laboratory specimens - nasal swabs for influenza PCR for patients who only had a rapid antigen test and blood specimens for patients who consent to additional blood drawing (for improved efficacy and safety analyses; not required for enrollment). Patients will be given oseltamivir by their healthcare providers. Research personnel's only involvement for oseltamivir dosing will be to remind providers that earlier treatment improves efficacy. Patients will then be given a single dose of baloxavir or placebo by the study's CRC as per a computerized random allocation scheme with dose determined by weight (as above); the CRC will notify the patient's provider that the patient has been given the single (blinded) dose. At time 1, 2, 3, 4, 7, and 30 days, nasal swabs will again be obtained, clinical information will be obtained from the patient via interview and review of the EMR, and blood specimens for patients who consented to additional blood drawing. Follow up will continue for 30 days.
Efficacy and adjudicated safety data points will be assessed by a Data Monitoring Committee (DMC) quarterly and as needed throughout the trial.
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 |
|---|---|---|
| baloxavir | Experimental | Drug: BaloxavirBaloxavir: 40 mg po once for wt < 80 kg OR 80 mg po once for wt >/= 80 kg |
| placebo | Placebo comparator | Drug: Placebosplacebo po once |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Adults >/= 18 years old
- Laboratory confirmed influenza A and/or B (rapid test or PCR)
- Able to be enrolled, randomized, and dosed with study drug within 8 hours of the decision to admit patient to hospital for treatment of influenza
- Oseltamivir treatment ordered by clinical team AND patient is able to be enrolled:
- Subject or Legally Authorized Representative able to and willing to provide written informed consent
Key exclusion criteria (9 listed)
- ESRD not undergoing hemodialysis (HD) or peritoneal dialysis (CAPD)
- Severe hepatic insufficiency, cirrhosis, acute or chronic liver failure
- Nausea/vomiting, aspiration risk, or other conditions precluding the ability to use oral medications (if patient is NPO including meds, otherwise unable to swallow oral medications)
- Influenza medication use within the prior week, other than the initial oseltamivir given during this hospitalization for this episode of influenza
- Oseltamivir or baloxavir allergy or intolerance
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 |
|---|---|---|
| Baloxaviradministered PO once | Drug | baloxavir |
| Placebosadministered PO once | Drug | placebo |
Primary outcome
Time to Clearance of Viral Shedding
Time frame: 30 days
influenza viral titer obtained by nasal swab using qCulture
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 14 May 2026.
- Individual participant dataSharing planned: No
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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.
Daniel Freilich, MD principal investigator
Bassett Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Baloxavir in people with Influenza, run by Bassett Healthcare at 3 sites in United States.
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 10 inclusion and 9 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 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Time to Clearance of Viral Shedding (time frame: 30 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 14 May 2026.