Trials / Completed
CompletedNCT04329650
Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID-19 Pneumonia
Phase 2, Randomized, Open-label Study to Compare Efficacy and Safety of Siltuximab vs. Corticosteroids in Hospitalized Patients With COVID19 Pneumonia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 163 (actual)
- Sponsor
- Judit Pich Martínez · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
In our center up to 25% of the hospitalized patients with COVID-19 progress and need an intensive care unit. It is urgent to find measures that can avoid this progression to severe stages of the disease. We hypothesize that the use of anti-inflammatory drugs used at the time they start hyperinflammation episodes could improve symptoms and prognosis of patients and prevent their progression sufficiently to avoid their need for be admitted to an Intensive Care Unit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Siltuximab | A single-dose of 11mg/Kg of siltuximab will be administered by intravenous infusion. |
| DRUG | Dexamethasone | A dose of 6mg/24 hours of dexamethasone during 10 days will be administered orally or by intravenous infusion. |
Timeline
- Start date
- 2020-04-15
- Primary completion
- 2021-02-26
- Completion
- 2021-02-26
- First posted
- 2020-04-01
- Last updated
- 2023-09-21
Locations
4 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT04329650. Inclusion in this directory is not an endorsement.