A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children
Recruiting
Phase 3
Interventional Study
Respiratory Syncytial Virus Infection
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 1 Month – 36 Months
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 498 (estimated)
- Sponsor
- Simcere Pharmaceutical Co., Ltd · Other
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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 dail…
Trial Locations
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Eligibility Criteria
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 S…
Contacts