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Found 2 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are studying zelicapavir, a new oral medication that stops the replication of Respiratory Syncytial Virus RSV. This Phase 2 trial is evaluating zelicapavir as a potential treatment for RSV infection in children aged 28 days to 36 months who have symptoms of RSV. The study compares zelicapavir to a placebo to assess its effects and safety in both hospitalized and non-hospitalized children. Participants are randomly assigned to receive either zelicapavir oral suspension or a matching placebo once daily for 7 days. The study monitors the time it takes for RSV symptoms to completely resolve, along with other outcomes such as the severity of symptoms, viral load changes, and any hospitalizations during the study period. These assessments occur mainly from Day 1 through Day 14, with safety followed until Day 35. During the trial, caregivers and children will be assessed regularly to track symptom resolution and viral levels using specific measurement tools. Safety is carefully monitored by recording any adverse events up to Day 35. The study spans from the initial dosing period through follow-up visits, ensuring comprehensive evaluation of zelicapavirs potential in treating RSV in young children.

Age: 28Days - 36MonthsAll GendersPhase 2
8 locations
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Actively Recruiting

Researchers are evaluating Remdesivir VEKLURY4 in children under two years old who are hospitalized with confirmed respiratory syncytial virus RSV infection. This Phase II, open-label, randomized controlled trial aims to assess the safety, antiviral activity, and acceptability of a five-day course of Remdesivir compared to standard care. The study focuses on how well the treatment reduces RSV replication and its safety profile in this young patient group. Participants will be randomly assigned to one of two groups one group will receive standard care alone, which may include oxygen therapy, bronchodilators, intravenous fluids, steroids, antibiotics, and treatment for underlying diseases as needed. The other group will receive Remdesivir by intravenous infusion every 24 hours for five consecutive days in addition to the standard care. Treatment doses will be based on the childs weight at the time of randomization. The study will enroll about 120 children and follow them throughout hospitalization plus a final visit 7 to 10 days after Day 6. Throughout the study, researchers will monitor participants for safety and tolerability of Remdesivir, measure RSV viral load, and assess the treatments effectiveness over one week. Assessments will include clinical observations, laboratory tests, and evaluations of respiratory status. The follow-up after hospitalization will help determine the lasting effects and acceptability of the treatment in this population.

Age: 0Days - 2YearsAll GendersPhase 2
8 locations