Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia : Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial
The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment.The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated..
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Klinische Studie| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 04. Aug. 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 14, 2020, Last downloaded: ClinicalTrials.gov processed this data on August 08, 2022, Last updated: August 10, 2022 |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG003358747 |
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| 245 | 1 | 0 | |a Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia |b Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial |
| 264 | 1 | |c 2022 | |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: April 14, 2020, Last downloaded: ClinicalTrials.gov processed this data on August 08, 2022, Last updated: August 10, 2022 | ||
| 520 | |a The study is a randomized, double blinded, placebo-controlled, multicenter study with two parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30% relative reduction in risk of mechanical ventilation or death at day 28. Patients with confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the study. The participants will be randomized 2:1 to the parallel treatment arms, and receive either single dose infusion treatment.The primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days. Interim analysis will be performed frequently.As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated. | ||
| 650 | 2 | |a Pneumonia | |
| 650 | 2 | |a Coronavirus Infections | |
| 650 | 2 | |a Pneumonia, Viral | |
| 650 | 4 | |a Medical Condition: COVID, Corona Virus Infection, Viral Pneumonia | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Terminated | |
| 650 | 4 | |a Phase: Phase 3 | |
| 650 | 4 | |a 610 | |
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