Influenza Disease; FluPhase 3INFLUENTNCT06653569
Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment)
A Phase 3 study testing Baloxavir Marboxil in people with Influenza Disease; Flu, run by Dre Pauline Vetter at 1 site in Switzerland.
Trial summary
The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza Disease; Flu
- What is being tested?
- Baloxavir Marboxil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 484 participants
- Where
- 1 siteSwitzerland
- Study dates
- 13 Dec 2024to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Participant or participant representative capable of giving signed informed consent.
- Positive reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A and/or B confirmed on arespiratory tract sample.
- Patient requiring hospitalization.
- National Early Warning Score 2 (NEWS2) of ≥4 at planned randomization
Who cannot join
- Ongoing pregnancy or breastfeeding (self-reported by the participant or diagnosed by the treating phyisician)
- Known contraindication to baloxavir or to the placebo
- Participant weighing < 40 kg
- Patients already on NAI therapy for the current influenza episode for > 24 hours at the time of randomization.
- Prior treatment with baloxavir for the current influenza epidose
- Immunosuppression defined as 1) cancer treatment with significant negative effect on the immune system; 2) immunosuppressive therapy (treatments comprising a dose of ≥20 mg/day prednisone or equivalent when administered for ≥ 2 weeks, biological therapies, steroid sparing drugs); 3) HIV infection if CD4+ T cell count < 500/µL; 4) organ or stem cell transplantation; 5) patients on the waiting list for a transplant
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- Severe underlying respiratory comorbidity requiring long-term oxygenotherapy at home.
- Severe disease requiring ICU care directly at hospitalization.
- Severe hepatic insufficiency or any other severe medical condition when participation in the study puts the patient at risk according to the investigator's judgment.
- History of inclusion in this study during a previous influenza season
- Inclusion in another interventional study with an investigational drug 30 days before inclusion in the study.
- Unability to consent or patient representative unable to consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1205
Pauline Vetter, +41(0)795539761, pauline.vetter@hug.ch
Krisztina Hosszu-Fellous, Krisztina.Hosszu-Fellous@hug.ch
About this study
Official title: A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza
The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
The main questions are:
Read more
- When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover?
- Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu?
- Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu?
- Can baloxavir reduce duration of contagiousness?
To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo.
Participants will:
- Take one single dose of baloxavir marboxil or placebo soon after hospitalization.
- Vital signs will be followed three times per day during hospital stay.
- Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation.
- Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.
Read the detailed description
Background: Influenza virus is a major source of seasonal outbreaks and is the leading candidate for a future pandemic. Each winter thousands of people are hospitalized with infection complications. The most at risk are the very young (< 5 years), the elderly (>65 years old) and those with a weak immune system. When a person is hospitalized because of the flu, it is not always clear if the administration of a specific medicine that fights the virus (called an antiviral) will help.
Most studies looked at antivral drug benefits among people with mild flu, who didn't need to be hospitalized. They found that if the antiviral is started early (up to two days after the symptoms started), it can make the symptoms go away a little faster. But for people in the hospital, especially if it's been more than two days since their symptoms started, it is not so sure if antiviral drugs still help. Clinical research involving patients hospitalized for disease complications is few and of lesser quality. While some indicate that early treatment might be beneficial, there is no scientific agreement about treatment benefits. Therefore, recommendations and antiviral prescription varies between hospitals and physicians.
In Switzerland two antiviral drugs are authorized to treat the flu: Tamiflu® and Xofluza®.
Study aims and methods: The goal of this industry-independent trial is to measure the benefits of Xofluza® compared to placebo (mock medication) in adult patients hospitalized for the flu.
Choice of the medication: The investigators chose Xofluza® instead of Tamiflu® because it is very simple to use (only a single pill instead of twice a day Tamiflu® for 5 days), it has fewer side effects and can be safely given to patients with a wide range of chronic diseases.
Importance: This study is very important because it could lead to a Swiss and international consensus about the utility of antiviral treatment in hospitalized patients.
If beneficial, Xofluza® might be the drug of choice in a future pandemic, when access to a simple to administer and easily stored drug effective at all stages of the illness with few side effects would be of utmost importance.
However, if the trial doesn't show any benefit of Xofluza® administration, antiviral treatment prescription won't be recommended, preserving patients from unneeded medication and from its potential side effects and saving ressources.
Tailoring antiviral use will also help prevent the risk of the virus becoming resistant which might happen in case of overuse.
Patient and public involvement: During the preparation of the study, patient representatives were involved in the development of the research idea, in the discussion concerning its ethical aspects, the feasibility of recruitment, and the selection of questionnaires to measure treatment benefits. They participated in the revision of the lay summary as well. The informed consent form has been developped together with them, in our communication efforts targeting potential participants at the start as well as in the dissemination of the results at the end of the study. Patients representatives also developped together with the investigators the strategy of participants recruitment.
- Conditions
- Influenza Disease; Flu
- Being tested
- Baloxavir Marboxil, Placebo
- Keywords
- antiviral treatment, baloxavir marboxil, influenza complications, hospitalization, severe influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baloxavir MarboxilDrug
The antiviral baloxavir marboxil administered in one unique dose.
1 capsule (40 mg) if participant weighs < 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg
PlaceboDrug
Patients in the placebo group will receive one unique dose of placebo. 1 capsule if participant weighs < 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg.
| Study group | Role | What they receive |
|---|---|---|
| antiviral treatment | Experimental | baloxavir marboxil Receives: Drug: Baloxavir Marboxil |
| placebo | Placebo comparator | Pacebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to clinical improvement
The primary outcome is the time to clinical improvement, calculated from treatment administration, assessed by time to hospital discharge alive or time to a NEWS2 score of 2 or lower maintained for 24 h, whichever comes first.
Measured: From treatment administration to hospital discharge or NEWS2 score of 2 or lower maintained for 24 h, whichever comes first, assessed up to day 90
Secondary outcomes (10)
Clinical status severity score
A patient's clinical improvement can be assessed by an additional scoring system. Here, a 6-point ordinal scale will be used to capture the different clinical trajectories of the patients (1: discharged; 2: subacute care; 3: acute care without respiratory failure; 4: acute care with respiratory failure; 5: intensive care unit; 6: death) and to measure antiviral treatment's potential benefits with a different tool.
Measured: At 7 days post treatment administration
Duration of hospitalization
Duration of hospitalization post-treatment administration, measured in hours
Measured: From treatment administration to hospital discharge, assessed up to day 90
Duration of Oxigen supplementation
Duration of O2 supplementation post-treatment administration (in hours).
Measured: From treatment administration to waining of oxygen therapy, assessed up to day 90 (in patients requiring oxygen).
In-hospital clinical failure
In-hospital clinical failure, defined as death or ICU or ICMU admission during hospitalization or up to 30 days post treatment administration in case of prolonged hospital stay.
Measured: From treatment administration to the end of hospital stay, maximum 30 days after treatment administration
Mortality
Mortality due to any cause.
Measured: From treatment administration during 90 days
Influenza-related complications
Influenza-related complications, diagnosed by the treating physician (composite outcome defined as pneumonia, sepsis, acute lung injury or ARDS, encephalitis/encephalopathy, myo or -pericarditis, otitis, sinusitis as well as any cardiovascular event (cardiac decompensation, myocardial infarction or stroke))
Measured: From treatment administration during 90 days
Antibiotic consumption
Number of antibiotic days (AD).
Measured: From treatment administration to the end of hospital stay, maximum 30 days after treatment administration
Change in quality of life at D90
Impact of antiviral treatment on patient quality of life after discharge using the EQ-5D-5L scale (5-level EQ-5D version).
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: At day 90-days post treatment administration
Viral shedding
Number of participants with detectable RNA in respiratory sample on day 3 after treatment administration.
Measured: On day 3 after treatment administration.
Duration of infectious viral shedding
Infectious viral load in respiratory sample at day 3 post-treatment administration.
Measured: On day 3 post-treatment administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start13 Dec 2024
- Primary completionApr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Influenza Disease; FluStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 484 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dre Pauline Vetter
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Geneva, University of Geneva, Switzerland, Ente Ospedaliero Cantonale, Ticino, Switzerland, Centre Hospitalier Universitaire Vaudois (Switzerland), University of Zurich, University Hospital, Zürich
- Responsible party
- Sponsor-investigator, Dre Pauline Vetter, University Hospital, Geneva
- Investigators
- Pauline Vetter, MD, Principal investigator, University Hospital, GenevaNicolas Muller, Professor, Principal investigator, Department of Infectious Diseases and Hospital epidemiology, University Hospital ZürichMatteo Mombelli, MD, Principal investigator, Department of internal medicine, Locarno Regional Hospital EOCOriol Manuel, Pr, Principal investigator, Center for organ transplantation, Lausanne University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653569
- Sponsor's protocol ID
- 2024-01535
- Other IDs
- 33IC30_221790
- Acronym
- INFLUENT
- Status last verified
- Apr 2026
- First submitted
- 18 Oct 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators plan to share individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). IPD can be shared with investigators whose proposed use of the data has been approved by an independent review committee, for, as an example, individual participant data meta-analysis. The approval of the biobank regulation committee, which includes the coordinating PI, the sites PI and the responsibles of the biobank is also required on a case by case basis.
Publications
Hosszu-Fellous K, Vetter P, Agoritsas T, Kaiser L. Which trial do we need? Randomized, placebo-controlled trial of antiviral treatment in patients hospitalized for influenza. Clin Microbiol Infect. 2024 May;30(5):567-569. doi: 10.1016/j.cmi.2024.01.025. Epub 2024 Feb 3. No abstract available.
PubMed 38316358Hosszu-Fellous K, Poncet A, Cabecinhas ARG, Schibler M, Meyer B, Prendki V, Huttner A, Carballo S, Pouillon M, Slankamenac K, Bart PA, Bernasconi E, Manuel O, Mombelli M, Mueller NJ, Kaiser L, Vetter P. Antiviral treatment in adult patients hospitalized for influenza: study protocol for a multi-center, randomized, placebo-controlled trial on the efficacy of baloxavir marboxil to reduce time to clinical improvement and the risk for severe complications (the INFLUENT trial). Trials. 2025 Nov 24;26(1):538. doi: 10.1186/s13063-025-09248-0.
PubMed 41286959
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Swiss Multi-center, Randomized, Placebo-controlled Trial on the Efficacy of Baloxavir Marboxil to Reduce Time to Clinical Improvement in Adult Patients Hospitalized for Influenza
- ClinicalTrials.gov ID
- NCT06653569
- Acronym / sponsor ID
- INFLUENT / 2024-01535
- Conditions
- Influenza Disease; Flu
- Keywords
- antiviral treatment, baloxavir marboxil, influenza complications, hospitalization, severe influenza
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 484 participants (estimated)
- Lead sponsor
- Dre Pauline VetterUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, University Hospital, Geneva, University of Geneva, Switzerland, Ente Ospedaliero Cantonale, Ticino, Switzerland, Centre Hospitalier Universitaire Vaudois (Switzerland), University of Zurich, University Hospital, Zürich
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 22 Oct 2024 (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.
The purpose of this clinical trial is to find out if the medication called baloxavir marboxil (sold under the brand name Xofluza®) can help to reduce the time needed to recover from flu when patients need an hospitalization. Patients infected by influenza and requiring a hospitalization will be approched to be included in the study.
The main questions are:
- When someone is hospitalized with a severe influenza infection, does baloxavir help to reduce the time needed to recover?
- Can baloxavir marboxil help to shorten the amount of time people need to stay in the hospital with severe flu?
- Can baloxavir marboxil help to reduce the risk of life-threatening complications as well as of death due to severe flu?
- Can baloxavir reduce duration of contagiousness?
To be able to measure the above, the investigators will compare two groups of patients: One group receiving baloxavir marboxil, the other group receiving a mock treatment called placebo.
Participants will:
- Take one single dose of baloxavir marboxil or placebo soon after hospitalization.
- Vital signs will be followed three times per day during hospital stay.
- Have a nose swab to detect the presence of influenza virus on the first and third day of trial participation.
- Answer to a short quality of life questionnaire on the phone 3 months after receiving the study treatment.
Detailed description
Background: Influenza virus is a major source of seasonal outbreaks and is the leading candidate for a future pandemic. Each winter thousands of people are hospitalized with infection complications. The most at risk are the very young (< 5 years), the elderly (>65 years old) and those with a weak immune system. When a person is hospitalized because of the flu, it is not always clear if the administration of a specific medicine that fights the virus (called an antiviral) will help.
Most studies looked at antivral drug benefits among people with mild flu, who didn't need to be hospitalized. They found that if the antiviral is started early (up to two days after the symptoms started), it can make the symptoms go away a little faster. But for people in the hospital, especially if it's been more than two days since their symptoms started, it is not so sure if antiviral drugs still help. Clinical research involving patients hospitalized for disease complications is few and of lesser quality. While some indicate that early treatment might be beneficial, there is no scientific agreement about treatment benefits. Therefore, recommendations and antiviral prescription varies between hospitals and physicians.
In Switzerland two antiviral drugs are authorized to treat the flu: Tamiflu® and Xofluza®.
Study aims and methods: The goal of this industry-independent trial is to measure the benefits of Xofluza® compared to placebo (mock medication) in adult patients hospitalized for the flu.
Choice of the medication: The investigators chose Xofluza® instead of Tamiflu® because it is very simple to use (only a single pill instead of twice a day Tamiflu® for 5 days), it has fewer side effects and can be safely given to patients with a wide range of chronic diseases.
Importance: This study is very important because it could lead to a Swiss and international consensus about the utility of antiviral treatment in hospitalized patients.
If beneficial, Xofluza® might be the drug of choice in a future pandemic, when access to a simple to administer and easily stored drug effective at all stages of the illness with few side effects would be of utmost importance.
However, if the trial doesn't show any benefit of Xofluza® administration, antiviral treatment prescription won't be recommended, preserving patients from unneeded medication and from its potential side effects and saving ressources.
Tailoring antiviral use will also help prevent the risk of the virus becoming resistant which might happen in case of overuse.
Patient and public involvement: During the preparation of the study, patient representatives were involved in the development of the research idea, in the discussion concerning its ethical aspects, the feasibility of recruitment, and the selection of questionnaires to measure treatment benefits. They participated in the revision of the lay summary as well. The informed consent form has been developped together with them, in our communication efforts targeting potential participants at the start as well as in the dissemination of the results at the end of the study. Patients representatives also developped together with the investigators the strategy of participants recruitment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| antiviral treatment | Experimental | Drug: Baloxavir Marboxilbaloxavir marboxil |
| placebo | Placebo comparator | Drug: PlaceboPacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Participant or participant representative capable of giving signed informed consent.
- Positive reverse transcriptase-polymerase chain reaction (RT-PCR) for influenza A and/or B confirmed on arespiratory tract sample.
- Patient requiring hospitalization.
- National Early Warning Score 2 (NEWS2) of ≥4 at planned randomization
Key exclusion criteria (12 listed)
- Ongoing pregnancy or breastfeeding (self-reported by the participant or diagnosed by the treating phyisician)
- Known contraindication to baloxavir or to the placebo
- Participant weighing < 40 kg
- Patients already on NAI therapy for the current influenza episode for > 24 hours at the time of randomization.
- Prior treatment with baloxavir for the current influenza epidose
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 |
|---|---|---|
| Baloxavir MarboxilThe antiviral baloxavir marboxil administered in one unique dose. 1 capsule (40 mg) if participant weighs < 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg | Drug | antiviral treatment |
| PlaceboPatients in the placebo group will receive one unique dose of placebo. 1 capsule if participant weighs < 80 kg; 2 capsules (80 mg) if participant weighs ≥ 80 kg. | Drug | placebo |
Primary outcome
Time to clinical improvement
Time frame: From treatment administration to hospital discharge or NEWS2 score of 2 or lower maintained for 24 h, whichever comes first, assessed up to day 90
The primary outcome is the time to clinical improvement, calculated from treatment administration, assessed by time to hospital discharge alive or time to a NEWS2 score of 2 or lower maintained for 24 h, whichever comes first.
10 secondary outcomes
Clinical status severity score
Time frame: At 7 days post treatment administration
Duration of hospitalization
Time frame: From treatment administration to hospital discharge, assessed up to day 90
Duration of Oxigen supplementation
Time frame: From treatment administration to waining of oxygen therapy, assessed up to day 90 (in patients requiring oxygen).
In-hospital clinical failure
Time frame: From treatment administration to the end of hospital stay, maximum 30 days after treatment administration
Mortality
Time frame: From treatment administration during 90 days
Influenza-related complications
Time frame: From treatment administration during 90 days
Antibiotic consumption
Time frame: From treatment administration to the end of hospital stay, maximum 30 days after treatment administration
Change in quality of life at D90
Time frame: At day 90-days post treatment administration
Viral shedding
Time frame: On day 3 after treatment administration.
Duration of infectious viral shedding
Time frame: On day 3 post-treatment administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 38316358Hosszu-Fellous K, Vetter P, Agoritsas T, Kaiser L. Which trial do we need? Randomized, placebo-controlled trial of antiviral treatment in patients hospitalized for influenza. Clin Microbiol Infect. 2024 May;30(5):567-569. doi: 10.1016/j.cmi.2024.01.025. Epub 2024 Feb 3. No abstract available.
- Derived from this study: PubMed 41286959Hosszu-Fellous K, Poncet A, Cabecinhas ARG, Schibler M, Meyer B, Prendki V, Huttner A, Carballo S, Pouillon M, Slankamenac K, Bart PA, Bernasconi E, Manuel O, Mombelli M, Mueller NJ, Kaiser L, Vetter P. Antiviral treatment in adult patients hospitalized for influenza: study protocol for a multi-center, randomized, placebo-controlled trial on the efficacy of baloxavir marboxil to reduce time to clinical improvement and the risk for severe complications (the INFLUENT trial). Trials. 2025 Nov 24;26(1):538. doi: 10.1186/s13063-025-09248-0.
- Individual participant dataSharing planned: Yes. The investigators plan to share individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). IPD can be shared with investigators whose proposed use of the data has been approved by an independent review committee, for, as an example, individual participant data meta-analysis. The approval of the biobank regulation committee, which includes the coordinating PI, the sites PI and the responsibles of the biobank is also required on a case by case basis.
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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.
Pauline Vetter, MD principal investigator
University Hospital, Geneva
Nicolas Muller, Professor principal investigator
Department of Infectious Diseases and Hospital epidemiology, University Hospital Zürich
Matteo Mombelli, MD principal investigator
Department of internal medicine, Locarno Regional Hospital EOC
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 Baloxavir Marboxil in people with Influenza Disease; Flu, run by Dre Pauline Vetter at 1 site in Switzerland.
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 12 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: looking for participants now, as of the sponsor's last update on 1 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 1 site in Switzerland. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pauline Vetter, MD (+41 79 55 39 761, Pauline.Vetter@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to clinical improvement (time frame: From treatment administration to hospital discharge or NEWS2 score of 2 or lower maintained for 24 h, whichever comes first, assessed up to day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06653569, which also lists 2 linked publications.
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 1 May 2026.