Studying the efficacy of IL-6 inhibition utilizing single or double dose subcutaneousadministration of Sarilumab in patients with severe respiratory distress caused byCOVID19 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.
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)
Inclusion Criteria:
1. Confirmed COVID-19 via centralized RT-PCR testing for SARS-CoV2 infection performed
at BayCare Health System Laboratory or associated and accredited laboratory.
2. Subjects must be hospitalized.
3. Document fever of 100.4 F or more during hospitalization and prior to enrollment.
4. Evidence of abnormal chest imaging chest x-ray or CT.
5. Moderate to severe respiratory distress requiring oxygen supplementation as defined
by criteria listed below.
"Oxygen saturation (Sao2) of 92% or less on room air or a ratio of the partial
pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) of less than 200
mm Hg, on ventilator settings that include PEEP ≥5 cm H2O".
6. Subjects may have active co-infection with other respiratory pathogens.
7. Males and non-pregnant females at least 18 years of age.
Exclusion Criteria:
1. The subject or Legally Authorized Representative is unable to provide consent in
person or by phone.
2. The subject is participating in any other clinical trial for treatment of COVID 19
or any other treatment related clinical trial for a concurrent disease. No plans for
additional COVID trials.
3. The subject does not meet criteria for moderate to severe respiratory distress.
4. The presence of any of the following lab abnormalities. ANC <2000/mm3, Platelet
count <50,000/mm3, ALT/AST >6x ULN
5. Prior utilization of any IL-6 inhibitors or receptor antagonists at any time in
patient's life, JAK inhibitors, DMARDS(Except Hydroxychloroquine), long term,
chronic steroid use (more than 6 months) or mTOR inhibitors.
6. The subject has history of organ or bone marrow transplant.
7. History of active or incompletely treated Tuberculosis (TB).
Morton Plant Hospital
Clearwater 4151316, Florida 4155751, United States
St. Anthony's Hospital
St. Petersburg 4171563, Florida 4155751, United States
St. Joseph's Hospital
Tampa 4174757, Florida 4155751, United States
Danielle Mauck, BA, Study Director
BayCare Health System