RECRUITINGPhase 3INTERVENTIONAL
A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
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
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).
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.
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)
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