Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by CO… (NCT07196306) | Clinical Trial Compass
WithdrawnPhase 2
Subcutaneous Sarilumab vs Placebo in Hospitalized Patients With Respiratory Distress Caused by COVID 19
Stopped: no participants enrolled
United States0Started 2020-05-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
✓. Subjects may have active co-infection with other respiratory pathogens.
✓. Males and non-pregnant females at least 18 years of age.
Exclusion criteria
✕. 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.