Convalescent Plasma Therapy for Hospitalized Patients With COVID-19 : Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil.
This is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19. Participants must be adult hospitalized patients with a confirmed diagnosis of COVID-19 and time Between symptom onset and inclusion ≤ 7 days. Two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 mL of high-titer COVID-19 convalescent plasma or standard care. The primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the World Health Organization. Safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. Study visits will occur on Day 1, Day 3, Day 7, and Day 14 or until hospital discharge, whichever comes first..
| Medienart: |
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Klinische Studie| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
ClinicalTrials.gov - (2023) vom: 29. Nov. Zur Gesamtaufnahme - year:2023 |
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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: October 14, 2021, Last downloaded: ClinicalTrials.gov processed this data on December 06, 2023, Last updated: December 06, 2023 |
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| Study ID: |
NCT05077930 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG007946716 |
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| 245 | 1 | 0 | |a Convalescent Plasma Therapy for Hospitalized Patients With COVID-19 |b Validation Protocol for The Clinical Use of Convalescent Plasma for Hospitalized Patients With COVID-19. A Prospective Study at a Hospital in Southern Brazil. |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: October 14, 2021, Last downloaded: ClinicalTrials.gov processed this data on December 06, 2023, Last updated: December 06, 2023 | ||
| 520 | |a This is an open-label, randomized controlled trial aimed to evaluate the efficacy and safety of using convalescent plasma for treating hospitalized patients with COVID-19. Participants must be adult hospitalized patients with a confirmed diagnosis of COVID-19 and time Between symptom onset and inclusion ≤ 7 days. Two hundred participants will be randomized in a 1:1 ratio to receive either 200-400 mL of high-titer COVID-19 convalescent plasma or standard care. The primary endpoint is the proportion of patients with clinical improvement at day 14 following randomization, defined by an increase of two points in the 7-point ordinal scale based on that recommended by the World Health Organization. Safety will be daily assessed by monitoring the occurrence of adverse effects and reactions to convalescent plasma transfusion. Study visits will occur on Day 1, Day 3, Day 7, and Day 14 or until hospital discharge, whichever comes first. | ||
| 650 | 2 | |a COVID-19 | |
| 650 | 2 | |a Coronavirus Infections | |
| 650 | 2 | |a Respiratory Tract Diseases | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
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