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lenzilumab (n=261) vs. placebo (n=259)
randomized controlled trial
Lenzilumab
Standard of care plus three intravenous doses of lenzilumab (600 mg per dose) delivered 8h apart. Infusions beginning at day 0 within 12h of randomisation.
Placebo
Standard of care plus three doses of 0.9% saline for injection delivered 8h apart.
All patients received standard supportive care, including the use of remdesivir and corticosteroids. Paracetamol 500–1000 mg orally or intravenously and diphenhydramine 12.5–25 mg intravenously or 25 mg orally (or equivalent) were administered approximately 1h before lenzilumab or placebo infusion to prevent hypersensitivity reactions.
COVID-19 mild to moderate
At least 18 years of age; experienced blood oxygen saturation (SpO2) of less than or equal to 94%; or required low-flow supplemental oxygen, or high-flow oxygen support, or non-invasive positive pressure ventilation (NIPPV); and were hospitalized but did not require IMV. Patients were excluded if they required IMV or extracorporeal membrane oxygenation (ECMO).
Double-blind.
29 sites in the US and Brazil.
For the purposes of the survival analysis for the primary endpoint, an event was defined as mortality or the requirement for IMV.
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