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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Respiratory Syncytial Virus Infection

In brief

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).

Key facts

Study ID

NCT07402512

Run by

Simcere Pharmaceutical Co., Ltd

People needed

498

Starts

2026-03-11

Expected to finish

2027-06-30

Last updated by the study team

2026-04-02

Who can join

Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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.

Where it is running

• The First Affiliated Hospital Of Xiamen University — Xiamen, Fujian, China (enrolling)
• Hunan Children's Hospital — Changsha, Hunan, China (enrolling)
• West China Second University Hospital Sichuan University — Chengdu, Sichuan, China
• Shulan(hangzhou)Hospital — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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