|Age:||18 years or older|
|Keywords:||COVID-19, coronavirus, viral infection, COVID-19 infection, coronavirus infection, hospitalization, coronavirus hospitalization|
|Type:||Drug study, Phase 2/3|
This is a randomized, double-blind, placebo-controlled study. “Randomized” means that the group you will be placed in is decided by chance, similar to drawing numbers out of a hat or flipping a coin. “Double-blind” means that neither you nor the study doctor will know which treatment group you have been placed in (ie, if you are receiving sarilumab or placebo). This is done to make sure the results of the study cannot be influenced by anyone. If there is an urgent need, the study doctor can find out quickly if you are receiving sarilumab or placebo. A placebo is an inactive substance, that looks like the medicine, but which contains no medicine. If you agree to take part in this study, you will receive either the sarilumab or placebo. You will have a 4 out of 5 or 80% chance of receiving the sarilumab.
This study consists of:
You will be randomly assigned to 1 of 3 possible study treatments. The study drug or placebo will be given through a vein (intravenous [IV] infusion).
You will be given either:
Sarilumab has been approved for subcutaneous (under the skin) use. This is the first study where 200 mg and 400 mg IV infusion will be given to human volunteers and the first study in which the 400 mg dose will be used.
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