Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) : A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19)
This is a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.A single arm, non-randomized, open-label phase is added to the protocol after completion of enrollment in the Randomized Phase of the study.The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period..
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Klinische Studie| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 14. Jan. Zur Gesamtaufnahme - year:2022 |
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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: April 15, 2020, Last downloaded: ClinicalTrials.gov processed this data on January 24, 2022, Last updated: January 26, 2022 |
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| Study ID: |
NCT04347239 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG003360237 |
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| 245 | 1 | 0 | |a Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) |b A Phase 2b/3, Randomized, Double Blind, Placebo Controlled, Adaptive Design Study to Evaluate the Efficacy and Safety of Leronlimab for Patients With Severe or Critical Coronavirus Disease 2019 (COVID-19) |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: April 15, 2020, Last downloaded: ClinicalTrials.gov processed this data on January 24, 2022, Last updated: January 26, 2022 | ||
| 520 | |a This is a Phase 2b/3, two-arm, randomized, double blind, placebo controlled, adaptive design multicenter study to evaluate the safety and efficacy of leronlimab (PRO 140) in patients with severe or critical symptoms of respiratory illness caused by coronavirus 2019 infection. Patients will be randomized to receive weekly doses of 700 mg leronlimab (PRO 140), or placebo. Leronlimab (PRO 140) and placebo will be administered via subcutaneous injection.A single arm, non-randomized, open-label phase is added to the protocol after completion of enrollment in the Randomized Phase of the study.The study will have three phases: Screening Period, Treatment Period, and Follow-Up Period. | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Coronavirus Infections | |
| 650 | 4 | |a Medical Condition: Coronavirus Disease 2019 | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Active, not recruiting | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
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