Treatment of RSV infection in hospitalized infants using Deuremidevir Hydrobromide

A Randomized, Double-blind, Placebo-controlled Phase II/III Clinical Trial to Evaluate the Safety and Efficacy of Deuremidevir Hydrobromide for Suspension in Hospitalized Infants Infected With Respiratory Syncytial Virus.

This study is testing a new medication called Deuremidevir Hydrobromide to see if it can help infants in the hospital who have a respiratory virus called RSV.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 1 Month to 24 Months
• Sex: All
• Sponsor: Vigonvita Life Sciences (Industry-sponsored)
• Locations: 22 sites (Bengbu, Anhui and 21 other locations)
• Trial ID: NCT06206720 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of Deuremidevir Hydrobromide for suspension in infants hospitalized with respiratory syncytial virus (RSV) infection. It is a randomized, double-blind, placebo-controlled, dose-ascending trial involving infants aged 1 to 24 months. Participants will be divided into three groups receiving different doses of the medication or a placebo, with a total of approximately 60 subjects. The study aims to assess the pharmacokinetic characteristics and antiviral activity of the treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are infants aged 1 to 24 months who have been diagnosed with RSV infection and are hospitalized.

Not a fit: Patients who are less than 12 months old with abnormal head circumference or those requiring vasopressors or inotropic support at enrollment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for infants suffering from RSV infection, potentially reducing hospitalization duration and improving recovery outcomes.

How similar studies have performed: While there have been studies on RSV treatments, this specific approach using Deuremidevir Hydrobromide is novel and has not been extensively tested in this context.

Eligibility criteria

Inclusion Criteria:

1. Male or female infants ≥1 month and ≤24 months；
2. Diagnosis of RSV infection by antigen detection or nucleic acid within 36 hours preceding initial dosing；
3. Onset of RSV infection symptoms should be ≤ 5 days；
4. Patient must weigh ≥ 2.5 kg and ≤ 20 kg at screening；
5. Patient must have a Wang Respiratory Score ≥ 5;
6. Patient who are hospitalized or in emergency/outpatient department and are expected to be hospitalized;
7. The parent/legal guardian must have provided written informed consent for the patient to participate.

Exclusion Criteria:

1. Patients who are less than 12 months old and whose head circumference is not within the normal range corresponding to their age and gender at the time of screening;
2. Patients who have received prohibited used drugs (except external preparations) specified in the protocol for a specified time.
3. Requires vasopressors or inotropic support at the time of enrollment;
4. Patients with known SARS-CoV-2 infection, influenza virus infection, mycoplasma infection or bacterial infection；
5. Patients with hypercapnia (Except for patients who have recovered at the time of screening);
6. Chronic or persistent feeding difficulties;
7. Concurrent gastrointestinal conditions that could seriously, in the opinion of the investigator, prejudice absorption of the Investigational Medicinal Product;
8. Symptomatic because of inborn errors of metabolism;
9. Bronchopulmonary dysplasia requiring assisted ventilationor with clinically significant congenital respiratory abnormalities, except for the result of RSV infection;
10. Patients with congenital heart disease (CHD) with significant hemodynamic changes, except simple CHD (such as patent ductus arteriosus, atrial septal defect or ventricular septal defect without hemodynamic influence).
11. Clinical evidence of hepatic decompensation
12. Renal failure including renal anomalies likely to be associated with renal insufficiency;
13. Patient is known to be HIV-positive (or the mother, if the potential patient is a child aged \<6 months);
14. Suspected or known to have congenital acquired immunodeficiency;
15. A history of epilepsy or seizures;
16. A history of high allergies;
17. Any active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal disease unrelated to RSV infection at baseline or any other medical condition that in the opinion of the investigator renders the patient unsuitable for enrollment;
18. Participation in an investigational drug or device study within 30 days prior to the date of screening;
19. Failure to satisfy the investigator of fitness to participate for any other reason.

Where this trial is running

Bengbu, Anhui and 21 other locations

• The first Affiliated hospital of Bengbu Medical University — Bengbu, Anhui, China (Recruiting)
• Chongqing University Jiangjin Hospital — Chongqing, Chongqing, China (Recruiting)
• Xiamen Children's Hospital — Xiamen, Fujian, China (Not_yet_recruiting)
• Xiamen Maternity and Child Healthcare Hospital — Xiamen, Fujian, China (Not_yet_recruiting)
• Guangdong Women and Children's Hospital and Health Institute — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Panyu Maternal and Child care Service centre of Guangzhou — Guangzhou, Guangdong, China (Recruiting)
• The Sceond Affiliated hospital of Shantou University Medical college — Shantou, Guangdong, China (Recruiting)
• Shenzhen Guangming District People's Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Liuzhou People's Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• Hainan women and children's Medical centre — Haikou, Hainan, China (Recruiting)
• Sanmenxia Central Hospital — Sanmenxia, Henan, China (Recruiting)
• Changde First people's Hospital — Changde, Hunan, China (Recruiting)
• Hunan Provincial Maternal and Child Health Care Hospital — Changsha, Hunan, China (Recruiting)
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Maternal and Child Health — Nanchang, Jiangxi, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Recruiting)
• Linfen Central Hospital — Linfen, Shanxi, China (Recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Recruiting)
• Shulan (hangzhou) Hosipital — Hangzhou, Zhejiang, China (Recruiting)
• Children's Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Hangzhou First people's Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: lanjuan li — Shulan (Hangzhou) Hospital
• Study coordinator: Huaqing Duan

Conditions Respiratory Syncytial Virus Infection