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

BayCare Health System

Status and phase: Withdrawn; Phase 2

Conditions: COVID-19; Corona Virus Infection; COVID

Treatments: Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07196306

1

Details and patient eligibility

About

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.

Full 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 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

Sarilumab

Experimental group

Description:

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

Treatment:

Drug: Sarilumab 200 MG/1.14 ML Subcutaneous Solution

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo