Administration of Anti-SARS-CoV-2 Convalescent Plasma in Hospitalized, Non-ICU Patients With COVID-19
Ключевые слова
абстрактный
Описание
This study is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of anti-SARS-CoV-2 convalescent plasma in COVID-19 patients.
After confirmation of COVID-19, patients that meet the eligibility requirement and provide informed consent will be randomized in a 2:1 ratio to anti-SARS-CoV-2 convalescent plasma (1 unit of approximately 250 ml) or placebo (1 unit albumin 5%, approximately 250 ml). We will evaluate the ability of anti-SARS-CoV-2 convalescent plasma vs. placebo control to decrease disease progression (measured by the WHO Ordinal Scale for Clinical Improvement) during the 28 days following administration to hospitalized, non-ICU patients. If patient is discharged from the hospital prior to Day 28, Day 28 assessment will be by phone.
Даты
| Последняя проверка: | 06/30/2020 |
| Первый отправленный: | 07/08/2020 |
| Предполагаемая регистрация отправлена: | 07/08/2020 |
| Первое сообщение: | 07/09/2020 |
| Последнее обновление отправлено: | 07/21/2020 |
| Последнее обновление опубликовано: | 07/23/2020 |
| Фактическая дата начала исследования: | 07/31/2020 |
| Предполагаемая дата завершения начальной школы: | 09/30/2021 |
| Предполагаемая дата завершения исследования: | 11/30/2021 |
Состояние или болезнь
Вмешательство / лечение
Drug: anti-SARS-CoV-2 plasma
Other: Placebo
Фаза
Группы рук
| Рука | Вмешательство / лечение |
|---|---|
| Experimental: anti-SARS-CoV-2 plasma Patients receive one dose (250-300ml) of anti-SARS-CoV-2 convalescent plasma | Drug: anti-SARS-CoV-2 plasma Administration of anti-SARS-CoV-2 convalescent plasma |
| Placebo Comparator: Placebo Patients receive one dose (250-300ml) of placebo (albumin 5%) | Other: Placebo Administration of placebo (albumin 5%) |
Критерии приемлемости
| Возраст, имеющий право на обучение | 18 Years Чтобы 18 Years |
| Полы, имеющие право на обучение | All |
| Принимает здоровых добровольцев | да |
| Критерии | Inclusion Criteria: - Patients ≥18 years of age - Hospitalized with COVID-19-related acute respiratory symptoms - Initial COVID-19 severity status on the WHO Ordinal Scale for Clinical Improvement = 3 ("Hospitalized, no oxygen therapy) or 4 ("Hospitalized, on oxygen by mask or nasal prongs") - Laboratory-confirmed COVID-19 - First signs of infection occurring no more than 14 days prior to enrollment Exclusion Criteria: - Receipt of pooled immunoglobulin in the past 30 days - Contraindication to transfusion or history of prior reactions to transfusion blood products - Admission to intensive care unit at any point during hospital course prior to enrollment |
Результат
Основные показатели результатов
1. Disease progression measured by WHO scale [Day 0 through Day 28 (or hospital discharge)]
Меры вторичного результата
1. Comparison of maximum WHO score per group [Day 0 through Day 28 (or hospital discharge)]
2. Comparison of decrease of median and maximum WHO score per group [Day 0 through Day 28 (or hospital discharge)]
3. Comparison of time to clinical improvement per group [Day 0 through Day 28 (or hospital discharge)]
4. Comparison of time to reach score of "6" or greater on the WHO scale [Day 0 through Day 28 (or hospital discharge)]
Другие показатели результатов
1. Comparison of hospital length of stay per group [Day 0 through Day 28 (or hospital discharge)]
2. Comparison of ICU length of stay per group [Day 0 through Day 28 (or hospital discharge)]
