Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children

Q: Who can participate in NCT07402512?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT07402512?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children (NCT07402512) is a Phase 3 interventional studying Respiratory Syncytial Virus Infection, sponsored by Simcere Pharmaceutical Co., Ltd. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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).

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Respiratory Syncytial Virus Infection, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 498 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender; 2. Weight ≥ 2.5 kg and ≤ 20 kg; 3. Positive RSV antigen or nucleic acid test 4. Duration of illness due to RSV infection ≤ 96 hours; 5. Presence of tachypnea and wheezing; 6. Wang Bronchiolitis Score≥ 5; 7. For subjects aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender. Who Should NOT Join This Trial: 1. Subjects who have received protocol-speciﬁed prohibited medications: 2. Subjects with severe intrapulmonary complications or extrapulmonary complications; 3. Subjects requiring vasopressors or inotropic agents; 4. Subjects with known concurrent SARS-CoV-2 infection, inﬂuenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections; 5. Subjects with a known history of hypercapnia; 6. Subjects with chronic or persistent feeding diﬃculties; 7. Subjects with gastrointestinal diseases that the investigator believes may signiﬁcantly aﬀect the absorption of the study drug; 8. Subjects with congenital metabolic abnormalities; 9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically signiﬁcant congenital respiratory tract abnormalities; 10. Subjects with congenital heart disease (CHD) that the investigator assesses may aﬀect eﬃcacy evaluation; 11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests; 12. Subjects with renal failure, including renal abnormalities potentially related to renal insuﬃciency or abnormal renal function tests; 13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator; 14. Subjects with known or suspected primary immunodeﬁciency diseases or transplant recipients; 15. Subjects with a history of epilepsy or febrile convulsions; 16. Subjects with a personal or family history of severe allergies or allergies; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Infants and young children aged ≥ 1 month and ≤ 36 months, regardless of gender; 2. Weight ≥ 2.5 kg and ≤ 20 kg; 3. Positive RSV antigen or nucleic acid test 4. Duration of illness due to RSV infection ≤ 96 hours; 5. Presence of tachypnea and wheezing; 6. Wang Bronchiolitis Score≥ 5; 7. For subjects aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender. Exclusion Criteria: 1. Subjects who have received protocol-speciﬁed prohibited medications: 2. Subjects with severe intrapulmonary complications or extrapulmonary complications; 3. Subjects requiring vasopressors or inotropic agents; 4. Subjects with known concurrent SARS-CoV-2 infection, inﬂuenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections; 5. Subjects with a known history of hypercapnia; 6. Subjects with chronic or persistent feeding diﬃculties; 7. Subjects with gastrointestinal diseases that the investigator believes may signiﬁcantly aﬀect the absorption of the study drug; 8. Subjects with congenital metabolic abnormalities; 9. Subjects with bronchopulmonary dysplasia requiring assisted ventilation or clinically signiﬁcant congenital respiratory tract abnormalities; 10. Subjects with congenital heart disease (CHD) that the investigator assesses may aﬀect eﬃcacy evaluation; 11. Subjects with clinical evidence of hepatic decompensation; or abnormal liver function tests; 12. Subjects with renal failure, including renal abnormalities potentially related to renal insuﬃciency or abnormal renal function tests; 13. Subjects with a known history of HIV positivity, or suspected to be HIV positive by the investigator; 14. Subjects with known or suspected primary immunodeﬁciency diseases or transplant recipients; 15. Subjects with a history of epilepsy or febrile convulsions; 16. Subjects with a personal or family history of severe allergies or allergies; 17. 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; 18. Subjects who participated in other drug or medical device clinical trials and received investigational products or devices; 19. Subjects deemed unsuitable for participation in this study by the investigator for any other reason.

Treatments Being Tested

DRUG

SIM0916

Dose: 20 mg/kg TID

DRUG

SIM0916 Placebo

Dose: 20 mg/kg TID

Locations (4)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The First Affiliated Hospital Of Xiamen University

Xiamen, Fujian, China

Hunan Children's Hospital

Changsha, Hunan, China

West China Second University Hospital Sichuan University

Chengdu, Sichuan, China

Shulan(hangzhou)Hospital

Hangzhou, Zhejiang, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07402512), the sponsor (Simcere Pharmaceutical Co., Ltd), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07402512 clinical trial studying?

Who can participate in NCT07402512?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07402512?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07402512. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07402512. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.