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New treatment option for Respiratory Syncytial Virus Infection
Official title A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
ClinicalTrials.gov ID: NCT07402512
What this study is testing
What is SIM0916?
SIM0916 is an investigational medicine, given as an once-daily, being studied as a potential treatment for respiratory syncytial virus infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 36
You may be able to join 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;
You likely can't join if
- people who have received protocol-specified prohibited medications:
- people with severe intrapulmonary complications or extrapulmonary complications;
- people requiring vasopressors or inotropic agents;
- people with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other...
- people with a known history of hypercapnia;
- people with chronic or persistent feeding difficulties;
See the full eligibility criteria
- 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 people aged \< 12 months, head circumference should be within the normal range corresponding to their age and gender.
- people who have received protocol-specified prohibited medications:
- people with severe intrapulmonary complications or extrapulmonary complications;
- people requiring vasopressors or inotropic agents;
- people with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;
- people with a known history of hypercapnia;
- people with chronic or persistent feeding difficulties;
- people with gastrointestinal diseases that the investigator believes may significantly affect the absorption of the study drug;
- people with congenital metabolic abnormalities;
- people with bronchopulmonary dysplasia requiring assisted ventilation or clinically significant congenital respiratory tract abnormalities;
- people with congenital heart disease (CHD) that the investigator assesses may affect efficacy evaluation;
- people with clinical evidence of hepatic decompensation; or abnormal liver function tests;
- people with renal failure, including renal abnormalities potentially related to renal insufficiency or abnormal renal function tests;
- people with a known history of HIV positivity, or suspected to be HIV positive by the investigator;
- people with known or suspected primary immunodeficiency diseases or transplant recipients;
- people with a history of epilepsy or febrile convulsions;
- people with a personal or family history of severe allergies or allergies;
- people with active or uncontrolled respiratory, cardiac, hepatic, central nervous system, or renal diseases, or other medical conditions deemed unsuitable for enrollment by the investigator;
- people who participated in other drug or medical device clinical trials and received investigational products or devices;
- people deemed unsuitable for participation in this study by the investigator for any other reason.
The study team makes the final eligibility decision.
Where it's taking place
- Xiamen, Fujian, China
- Changsha, Hunan, China
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 month to 36 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Xiamen, Fujian, China; Changsha, Hunan, China; Chengdu, Sichuan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.