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

NCT07196306 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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 in oxygen demands and other clinical outcomes.

Conditions

COVID; COVID-19; Corona Virus Infection

Outcome Measures

Primary Outcomes (1)

• 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 to improvement up to 28 days

Secondary Outcomes (18)

• Time to improvement in oxygenation

  Time to improvement up to 28 days

• The number of patients with a need for intubation

  Up to 28 days

• Time on ventilator

  Up to 28 days

• Fever resolution

  Up to 28 days

• Hemodynamic improvement to normal range

  Up to 28 days

Study Arms (2)

Sarilumab

EXPERIMENTAL

200 mg in 1.14 mL Subcutaneous x 1 or 2 dose(s)

Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution

Placebo

PLACEBO COMPARATOR

Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s)

Drug: Placebo

Interventions

Sarilumab 200 MG/1.14 ML Subcutaneous Solution DRUG

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.

Sarilumab

Placebo DRUG

Normal saline 0.9% 1.14 mL Subcutaneous x 1 or 2 dose(s)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Sponsors & Collaborators

• BayCare Health System: lead

Study Sites (3)

Morton Plant Hospital

Clearwater, Florida, 33756, United States

Location

St. Anthony's Hospital

St. Petersburg, Florida, 33705, United States

Location

St. Joseph's Hospital

Tampa, Florida, 33614, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

sarilumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Danielle Mauck, BA

  BayCare Health System

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2020
• First Posted: September 29, 2025
• Study Start: May 7, 2020
• Primary Completion: August 31, 2020
• Study Completion: October 15, 2020
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)