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Actively Recruiting
Researchers are investigating the safety, effectiveness, and acceptance of a five-day course of Remdesivir (VEKLURY4) in children under two years old who are hospitalized with confirmed respiratory syncytial virus (RSV) infection. This Phase II, open-label, multicenter, randomized controlled trial aims to see if Remdesivir can safely reduce RSV replication and be well accepted in this young patient population. The study involves 120 participants and compares standard care alone to standard care plus Remdesivir treatment. Participants will be randomly assigned to one of two groups: one receiving the standard care alone, and the other receiving Remdesivir alongside standard care. Remdesivir is given by intravenous infusion every 24 hours for five consecutive days. The study monitors children hospitalized with RSV infection, with follow-up visits occurring 7 to 10 days after the fifth day of treatment. During the study, children will be assessed for safety and tolerability of Remdesivir, including monitoring clinical signs and laboratory tests. Researchers will evaluate antiviral activity and acceptability of the treatment. The total participation includes the hospitalization period plus additional follow-up days post-treatment to ensure safety and gather final study data.