Health TrialsbyHealthPanel

A Phase III Study of Deuremidevir Hydrobromide for the Treatment of RSV Infection in Infants and Young Children

ConditionRespiratory Syncytial Virus Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age1-36
SponsorSimcere Pharmaceutical Co., Ltd

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Subjects with severe intrapulmonary complications or extrapulmonary complications;

Subjects requiring vasopressors or inotropic agents;

Subjects with known concurrent SARS-CoV-2 infection, influenza virus infection, Mycoplasma infection, or suspected concurrent bacterial or other pathogen infections;

Subjects with a known history of hypercapnia;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SIM0916

    Drug

    Dose: 20 mg/kg TID

  • SIM0916 Placebo

    Drug

    Dose: 20 mg/kg TID

Treatment groups

498 Participants
are divided into 2 treatment groups
Group A: SIM0916Experimental treatment 1 intervention
Group B: SIM0916 PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms

The earliest time from the first dose to the sustained resolution of 6 RSV infection-related clinical signs and symptoms. Resolution of 6 RSV infection-related clinical signs and symptoms is defined as a score of 0 for all of 6 RSV infection-related clinical signs.

Time frame
Day 26

Secondary outcomes

1

The earliest time from the first dose to the sustained relief/resolution of wheezing.Relief/resolution of wheezing is defined as a wheezing score ≤ 1.

Time frame
Day 26
2

Change in Wang Bronchiolitis Score from baseline on Days 2-6 and Day 14 after the first dose

Time frame
Day 26
3

Time from the first dose to disease recovery: the earliest time when Wang Bronchiolitis Score ≤ 1

Time frame
Day 26
4

Proportion of subjects achieving RSV disease recovery (Wang Bronchiolitis Score ≤ 1 at daily assessment) on each day from Day 2 to Day 6 and on Day 14 after the first dose

Time frame
Day 26

Other outcomes

1

Change in viral load from baseline on Days 2-6 and Day 14 after the first dose

Time frame
Day 26
2

Proportion of subjects with viral load below the Lower Limit of Quantitation (LLOQ) on Days 2-6 and Day 14 after the first dose

Time frame
Day 26
3

Area under the viral load-time curve from baseline to Days 2-6 and Day 14 after the first dose

Time frame
Day 26

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Simcere Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
Apply now