Respiratory Syncytial Virus InfectionPhase 3NCT07402512
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
A Phase 3 study testing SIM0916 in people with Respiratory Syncytial Virus Infection, run by Simcere Pharmaceutical Co., Ltd at 4 sites in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection. A total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration… Read more about this study
- Who is it for?
- Ages 1 month to 36 months
- Conditions the study is for
- Respiratory Syncytial Virus Infection
- What is being tested?
- SIM0916
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 4 sitesChina
- Study dates
- 11 Mar 2026to 30 Jun 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 1 month to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;
- Weight ≥ 2.5 kg and ≤ 20 kg;
- Positive RSV antigen or nucleic acid test
- Duration of illness due to RSV infection ≤ 96 hours;
- Presence of tachypnea and wheezing;
- Wang Bronchiolitis Score≥ 5;
- For subjects aged < 12 months, head circumference should be within the normal range corresponding to their age and gender.
Who cannot join
- Subjects who have received protocol-specified prohibited medications:
- Subjects with severe intrapulmonary complications or extrapulmonary complications;
- Subjects requiring vasopressors or inotropic agents;
- Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;
- Subjects with a known history of hypercapnia;
- Subjects with chronic or persistent feeding difficulties;
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- Subjects with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;
- Subjects with congenital metabolic abnormalities;
- Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;
- Subjects with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;
- Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests;
- Subjects with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;
- Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator;
- Subjects with known or suspected primary immunodeficiency diseases or transplant recipients;
- Subjects with a history of epilepsy or febrile convulsions;
- Subjects with a personal or family history of severe allergies or allergies;
- Subjects with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator;
- Subjects who participated in other drug or medical device clinical trials and received investigational products or devices;
- Subjects deemed unsuitable for participation in this study by the investigator for any other reason.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China4 sites, 4 recruiting
- Recruiting
Hunan Children's Hospital
Changsha, Hunan
Yanping Chen, hnchengyanping@163.com
- Not yet recruiting
West China Second University Hospital Sichuan University
Chengdu, Sichuan
Hanmin Liu, (028) 85503960, Hanmin@vip.163.com
- Not yet recruiting
Shulan(hangzhou)Hospital
Hangzhou, Zhejiang
lanjuan Li, 86 571 87236456, ljli@zju.edu.cn
- Recruiting
The First Affiliated Hospital Of Xiamen University
Xiamen, Fujian
Yungang Yang, 86-0592-2137303, xmyyg@sina.com
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection
This is a randomized, double-blind, placebo-controlled, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection.
A total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg/kg three times daily for 5 consecutive days (15 doses).
- Conditions
- Respiratory Syncytial Virus Infection
- Being tested
- SIM0916, SIM0916 Placebo
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIM0916Drug
Dose: 20 mg/kg TID
SIM0916 PlaceboDrug
Dose: 20 mg/kg TID
| Study group | Role | What they receive |
|---|---|---|
| SIM0916 | Experimental | Not described Receives: Drug: SIM0916 |
| SIM0916 Placebo | Placebo comparator | Not described Receives: Drug: SIM0916 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms. Resolution of 6 RSV infection-related clinical signs and symptoms is defined as a score of 0 for all of 6 RSV infection-related clinical signs.
Measured: Day 26
Secondary outcomes (11)
The earliest time from the first dose to the sustained relief/resolution of wheezing.Relief/resolution of wheezing is defined as a wheezing score ≤ 1.
Measured: Day 26
Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose
Measured: Day 26
Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1
Measured: Day 26
Proportion of subjects achieving RSV disease recovery (Wang Bronchiolitis Score ≤ 1 at daily assessment) on each day from Day 2 to Day 6 and on Day 14 after the first dose
Measured: Day 26
Earliest time from the first dose to the sustained resolution of individual RSV infection-related clinical signs and symptoms
Measured: Day 26
Proportion of subjects with resolution of individual RSV infection-related clinical signs and symptoms
Measured: Day 26
Proportion of subjects with wheezing score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose;
Measured: Day 26
Time from the first dose to the sustained relief/resolution of cough. Relief/resolution of cough is defined as a cough score ≤ 1
Measured: Day 26
Proportion of subjects with cough score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose
Measured: Day 26
Number and duration of admissions to the Intensive Care Unit (ICU) due to RSV infection-related diseases;
Measured: Day 26
Number of times of non-invasive positive pressure ventilation or mechanical ventilation received due to RSV infection-related diseases
Measured: Day 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start11 Mar 2026
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionStudies 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
- Parallel Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 498 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simcere Pharmaceutical Co., Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- hanmin liu, Principal investigator, West China Second University Hospitallanjuan Li, Principal investigator, Shulan (Hangzhou) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402512
- Sponsor's protocol ID
- SIM0916-301
- Status last verified
- Mar 2026
- First submitted
- 4 Feb 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Deurremidevir Hydrobromide for Oral Suspension in Infants and Young Children With Respiratory Syncytial Virus Infection
- ClinicalTrials.gov ID
- NCT07402512
- Acronym / sponsor ID
- SIM0916-301
- Conditions
- Respiratory Syncytial Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 498 participants (estimated)
- Lead sponsor
- Simcere Pharmaceutical Co., LtdUniversity, hospital or other
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Feb 2026 (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, parallel-group trial conducted in infants and young children aged 1 to 36 months with RSV infection.
A total of 498 subjects are expected to be enrolled and randomly assigned to the investigational product group or the placebo group in a 2:1 ratio; Administration will be based on the subject's weight, with a dose of 20 mg/kg three times daily for 5 consecutive days (15 doses).
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
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| SIM0916 | Experimental | Drug: SIM0916 |
| SIM0916 Placebo | Placebo comparator | Drug: SIM0916 Placebo |
Who may qualify
- Ages
- 1 month to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender;
- Weight ≥ 2.5 kg and ≤ 20 kg;
- Positive RSV antigen or nucleic acid test
- Duration of illness due to RSV infection ≤ 96 hours;
- Presence of tachypnea and wheezing;
Key exclusion criteria (19 listed)
- Subjects who have received protocol-specified prohibited medications:
- Subjects with severe intrapulmonary complications or extrapulmonary complications;
- Subjects requiring vasopressors or inotropic agents;
- Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;
- Subjects with a known history of hypercapnia;
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 |
|---|---|---|
| SIM0916Dose: 20 mg/kg TID | Drug | SIM0916 |
| SIM0916 PlaceboDose: 20 mg/kg TID | Drug | SIM0916 Placebo |
Primary outcome
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms
Time frame: Day 26
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms. Resolution of 6 RSV infection-related clinical signs and symptoms is defined as a score of 0 for all of 6 RSV infection-related clinical signs.
11 secondary outcomes
The earliest time from the first dose to the sustained relief/resolution of wheezing.Relief/resolution of wheezing is defined as a wheezing score ≤ 1.
Time frame: Day 26
Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose
Time frame: Day 26
Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1
Time frame: Day 26
Proportion of subjects achieving RSV disease recovery (Wang Bronchiolitis Score ≤ 1 at daily assessment) on each day from Day 2 to Day 6 and on Day 14 after the first dose
Time frame: Day 26
Earliest time from the first dose to the sustained resolution of individual RSV infection-related clinical signs and symptoms
Time frame: Day 26
Proportion of subjects with resolution of individual RSV infection-related clinical signs and symptoms
Time frame: Day 26
Proportion of subjects with wheezing score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose;
Time frame: Day 26
Time from the first dose to the sustained relief/resolution of cough. Relief/resolution of cough is defined as a cough score ≤ 1
Time frame: Day 26
Proportion of subjects with cough score ≤ 1 at daily assessment on each day from Day 2 to Day 6 and on Day 14 after the first dose
Time frame: Day 26
Number and duration of admissions to the Intensive Care Unit (ICU) due to RSV infection-related diseases;
Time frame: Day 26
Number of times of non-invasive positive pressure ventilation or mechanical ventilation received due to RSV infection-related diseases
Time frame: Day 26
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 2 Apr 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.
hanmin liu principal investigator
West China Second University Hospital
lanjuan Li principal investigator
Shulan (Hangzhou) Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SIM0916 in people with Respiratory Syncytial Virus Infection, run by Simcere Pharmaceutical Co., Ltd at 4 sites 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 7 inclusion and 19 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 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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. 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 zhibiao song (86-13641133681, songzhibiao@simcere.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms (time frame: Day 26). 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 2 Apr 2026.