COVID-19 EFC16844

Phase 2

• To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe COVID-19

 

Phase 3

• To evaluate the clinical efficacy of sarilumab relative to the control arm in adult patients hospitalized with severe or critical COVID-19

 

Phase 2 and Phase 3

•  Evaluate the clinical efficacy of sarilumab compared to the control arm by clinical severity
•  Evaluate changes in the National Early Warning Score 2 (NEWS2)
•  Evaluate the duration of predefined symptoms and signs (if applicable)
•  Evaluate the duration of supplemental oxygen dependency (if applicable)
•  Evaluate the incidence of new mechanical ventilation use during the study
•  Evaluate the duration of new mechanical ventilation use during the Study
•  Evaluate need for admission into intensive care unit (ICU)
•  Evaluate duration of hospitalization (days)
•  Evaluate the 28-day mortality rate
• […]

 Hospitalized (or documentation of a plan to admit to the hospital if the patient is in an emergency department) with illness of any duration with evidence of pneumonia by chest radiograph, chest computed tomography or chest auscultation (rales, crackles) and Fever (defined as >36.6°C [axilla], or >37.2 °C [oral], or >37.8°C [rectal or tympanic]) documented in the medical record and meets at least one of the following at baseline (patients meeting more than one criterion will be categorized in the most severely affected category). Participants who are:

Severe disease:

• Requires supplemental oxygen administration by nasal cannula, simple face     mask, or other similar oxygen delivery device (ie, above pre-COVID baseline requirement, if any, by the patient).

 Critical disease (applicable to phase 3 only):

• Requires supplemental oxygen delivered by non-rebreather mask or high-flow nasal cannula

OR

- Use of invasive or non-invasive ventilation

OR

• Requiring treatment in an intensive care unit.

Multi-system organ dysfunction (applicable to phase 3 only):

• Use of vasopressors, extracorporeal life support, or renal replacement therapy

[…]

• In the opinion of the investigator, unlikely to survive for >48 hours from screening.
•  Presence of any of the following abnormal laboratory values at screening: absolute neutrophil count (ANC) less than 2000/mm3, AST or ALT greater than 5 x ULN, platelets <50,000 per mm3
• E 03. Any prior (within the defined periods below) or concurrent use of immunosuppressive therapies including but not limited to the following:
  • Anti-IL-6, anti-IL-6R antagonists or with Janus kinase inhibitors (JAKi) in the past 30 days or plans to receive during the study period (other than interventional drug).
  • Cell-depletion agents (eg, anti CD20) without evidence of recovery of B cells to baseline level.
  • Anakinra within 1 week of baseline.
  • Abatacept within 8 weeks of baseline.

[…]

Sarilumab 200 mg i.v.

Sarilumab 400 mg i.v

Placebo