Study of Obeldesivir in Children and Adolescents With COVID-19 : A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19
Pediatric participants will be enrolled as follows:Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kgCohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kgCohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kgCohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kgCohort 5: ≥ 14 days to < 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kgCohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kgCohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg.
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 26. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: August 18, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 |
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| Study ID: |
NCT05996744 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG000148644 |
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| 245 | 1 | 0 | |a Study of Obeldesivir in Children and Adolescents With COVID-19 |b A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants With COVID-19 |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: August 18, 2023, Last downloaded: ClinicalTrials.gov processed this data on April 03, 2024, Last updated: April 03, 2024 | ||
| 520 | |a Pediatric participants will be enrolled as follows:Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kgCohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kgCohort 3: ≥ 2 years to < 18 years and weight ≥ 12 kg to < 20 kgCohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kgCohort 5: ≥ 14 days to < 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥ 2.5 kgCohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kgCohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 2, Phase 3 | |
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