NCT07196306

Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19

Study of Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BayCare Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneous administration of Sarilumab in patients with severe respiratory distress caused by COVID19 regarding improvement in oxygen demands and other clinical outcomes.

Detailed description

At the time of writing this protocol, there does not exist any strategy to treat acute respiratory distress syndrome associated with COVID-19. Due to the overwhelming health crisis facing a large portion of the population, and due to lack of standardization or clinical approach to management of severe respiratory failure short of standard of care with oxygenation and supportive measures, we elected to embark on this study to evaluate the role of IL-6 stimulating the immune system and the effect of inhibiting signal propagation on clinical outcome. For this study, Sarilumab, an FDA approved IL-6 receptor antagonist, currently used for severe rheumatoid arthritis, has been selected. The dose and administration of therapy used for the study conforms to the current FDA recommendation for the primary use of Sarilumab.

Conditions

• COVID
• COVID-19
• Corona Virus Infection

Interventions

Type	Name	Description
DRUG	Sarilumab 200 MG/1.14 ML Subcutaneous Solution	At the time of enrollment, the intervention arm subjects are administered single or double dose of study drug while the placebo arm subjects are administered the placebo drug (normal saline). Subjects will be assigned to the intervention or placebo arm in random order.
DRUG	Placebo	Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s)

Timeline

• Start date: 2020-05-07
• Primary completion: 2020-08-31
• Completion: 2020-10-15
• First posted: 2025-09-29
• Last updated: 2025-09-29

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study