Status:
WITHDRAWN
Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19
Lead Sponsor:
BayCare Health System
Conditions:
COVID
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 i...
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 port...
Eligibility Criteria
Inclusion
- Confirmed COVID-19 via centralized RT-PCR testing for SARS-CoV2 infection performed at BayCare Health System Laboratory or associated and accredited laboratory.
- Subjects must be hospitalized.
- Document fever of 100.4 F or more during hospitalization and prior to enrollment.
- Evidence of abnormal chest imaging chest x-ray or CT.
- 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".
- Subjects may have active co-infection with other respiratory pathogens.
- Males and non-pregnant females at least 18 years of age.
Exclusion
- The subject or Legally Authorized Representative is unable to provide consent in person or by phone.
- 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.
- The subject does not meet criteria for moderate to severe respiratory distress.
- The presence of any of the following lab abnormalities. ANC \<2000/mm3, Platelet count \<50,000/mm3, ALT/AST \>6x ULN
- 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.
- The subject has history of organ or bone marrow transplant.
- History of active or incompletely treated Tuberculosis (TB).
Key Trial Info
Start Date :
May 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 15 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07196306
Start Date
May 7 2020
End Date
October 15 2020
Last Update
September 29 2025
Active Locations (3)
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1
Morton Plant Hospital
Clearwater, Florida, United States, 33756
2
St. Anthony's Hospital
St. Petersburg, Florida, United States, 33705
3
St. Joseph's Hospital
Tampa, Florida, United States, 33614