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

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: COVID, COVID-19, Corona Virus Infection

In brief

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.

Key facts

Study ID

NCT07196306

Run by

BayCare Health System

People needed

0

Starts

2020-05-07

Expected to finish

2020-10-15

Last updated by the study team

2025-09-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Morton Plant Hospital — Clearwater, Florida, United States
• St. Anthony's Hospital — St. Petersburg, Florida, United States
• St. Joseph's Hospital — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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