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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
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.
Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s)
Morton Plant Hospital
Clearwater, Florida, United States
St. Anthony's Hospital
St. Petersburg, Florida, United States
St. Joseph's Hospital
Tampa, Florida, United States
Time to clinical outcome improvement
Time from randomization to improvement in oxygenation. Improvement in oxygenation is defined as SpO2/FiO2 improvement by 100 or greater.
Time frame: Time to improvement up to 28 days
Time to improvement in oxygenation
Time from randomization to no requirement of any oxygen supplementation with Oxygen saturation of \> =92% at rest.
Time frame: Time to improvement up to 28 days
The number of patients with a need for intubation
Time frame: Up to 28 days
Time on ventilator
Time frame: Up to 28 days
Fever resolution
A continuous period at least 48 hours without a recorded temperature equal or more than 100.4 F.
Time frame: Up to 28 days
Hemodynamic improvement to normal range
Heart rate
Time frame: Up to 28 days
Improvement or normalization in CBC
CBC with differential
Time frame: At 48 hours post intervention up to 28 days
Time to objective improvement noted on chest imaging
Time frame: Up to 28 days
Time from randomization to hospital discharge
Time frame: Up to 28 days
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Death
Time frame: Up to 28 days
Hemodynamic improvement to normal range
Respiratory rate
Time frame: Up to 28 days
Improvement or normalization in CMP
Comprehensive Metabolic Panel
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in LDH
LDH
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in Lactic Acid
Lactic Acid
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in Procalcitonin
Procalcitonin
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in Ferritin
Ferritin
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in CRP
CRP
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in D-Dimer
D-Dimer
Time frame: At 48 hours post intervention up to 28 days
Improvement or normalization in IL-6
IL-6
Time frame: At 48 hours post intervention up to 28 days