The Use of Tocilizumab in the Management of Patients Who Have Severe COVID-19 With Suspected Pulmonary Hyperinflammation
Ключови думи
Резюме
Описание
Study design This is a multicenter, two arms, 2:1 (treatment: control) open-label randomized control study with a drug approved for another indication in Israel. All the patients enrolled will be treated with tocilizumab or not. One-month mortality rate is the primary endpoint. One arm will be the study drug anti-IL6R (Tocilizumab (Actmera)) 8 mg/kg given IV during one hour once. The placebo will be a 100 ml saline IV infusion administered along one hour.
Дати
| Последна проверка: | 03/31/2020 |
| Първо изпратено: | 04/22/2020 |
| Очаквано записване подадено: | 05/04/2020 |
| Първо публикувано: | 05/05/2020 |
| Изпратена последна актуализация: | 05/04/2020 |
| Последна актуализация публикувана: | 05/05/2020 |
| Действителна начална дата на проучването: | 04/07/2020 |
| Приблизителна дата на първично завършване: | 04/28/2020 |
| Очаквана дата на завършване на проучването: | 05/07/2021 |
Състояние или заболяване
Интервенция / лечение
Drug: Tocilizumab
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Tocilizumab treatment group Treatment: intravenous administration of monoclonal anti body anti- IL6R. The dose is 8 mg/kg up to total dose of 800 mg. | |
| Placebo Comparator: Placebo group Placebo. intravenous administration of 100 ml of normal saline. |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: 1. Any gender 2. Age 18 and older 3. Informed consent for participation in the study 4. Virological diagnosis of Sars-CoV2 infection (PCR) 5. Acute respiratory failure 6. Radiographic pneumonia, defined as any/ changing new lung infiltrate 7. Patient breathing spontaneously, required more than 50% oxygen and MEWS score > 7. 8. If intubated, intubated less than 24 hours with PaO2/Fio2 ratio ≤ 200 and PEEP ≥ 5 cm H2O. Exclusion Criteria: 1. Known hypersensitivity to tocilizumab or its excipients 2. Patient with a life expectancy of less than 6 months. 3. Known active infections or other clinical condition that contra-indicate tocilizumab and cannot be treated or solved according to the judgement of the clinician. 4. Neutrophils <500 / mmc 5. Platelets <40.000 / mmc |
Резултат
Първични изходни мерки
1. Survival [One-month]
