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.
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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

zhibiao song

86-13641133681

songzhibiao@simcere.com

CONTACT