Status:
COMPLETED
Sarilumab for Patients With Moderate COVID-19 Disease
Lead Sponsor:
Westyn Branch-Elliman
Conditions:
COVID
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objectives: To determine whether blockade of IL-6R is beneficial in patients with COVID-19 infection of moderate severity. Research Design: Randomized, controlled trial. Two-arm trial comparing stand...
Detailed Description
1. Aims/Objectives The effectiveness of blockade of IL-6R in treating patients with COVID-19 disease of moderate severity will be tested in a pragmatic and adaptive randomized trial. The primary o...
Eligibility Criteria
Inclusion
- Study subjects will be inpatients with confirmed SARS-CoV-2 testing. Testing is performed at the discretion of the treating physician. Only Veterans will be enrolled.
- Positive testing for novel coronavirus SARS-CoV-2019
- Patients with moderate COVID-19 disease as defined clinically:
- Score of 1-3 (out of 3) on a modified Brescia COVID respiratory severity score (BCRSS), elements of which include wheezing or inability to speak complete sentences without effort, respiratory rate ≥22, O2 saturation ≤ 94% with or without supplemental oxygen, or requiring ≥2L supplemental oxygen to maintain O2 Sat \>94% in patients without previously documented hypoxia or baseline oxygenation requirement; either is equal to one point on the score) all within a 24-hour period prior to enrollment, and/or any worsening of chest X-ray (CXR) findings after COVID-19 diagnosis
- Worsening of baseline oxygenation by at least 3%, or increase in oxygen requirement by at least 2L, in patients with pre-existing hypoxemia or receiving supplemental oxygen chronically.
- The BCRSS risk calculation score is available at: https://www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm
Exclusion
- Critical disease, defined by need for mechanical ventilation
- Expected death within 48 hours
- Patients taking any of the following for chronic inflammatory diseases: glucocorticoids equivalent to prednisone \> 10 mg/day (methylprednisolone \> 8 mg/day, dexamethasone \> 2 mg/day), a JAK inhibitor (tofacitinib, baricitinib, upadacitinib), or a biologic
- Use of chronic inhaled steroids is NOT an exclusion
- Current or recent short-term use of glucocorticoids for chronic conditions such as COPD or gout is NOT an exclusion.
- Current use of glucocorticoids for COVID-19 is NOT an exclusion
- Use of biologics for non-inflammatory diseases is NOT an exclusion
- Receipt of any IL-6 inhibitor within 3 months prior to enrollment in the trial
- Pregnancy, due to lack of fetal monitoring capabilities
- Patients enrolled in other interventional clinical trials, including for COVID-19. Patients enrolled in non-interventional studies or receiving non-FDA-approved drugs for compassionate use are not excluded.
- Patients whose goal of care is comfort measures only
- Inability to provide informed consent, or absence of a legally authorized representative to provide informed consent.
- Severe psychiatric disease that prevents compliance with typical medical care.
- Initial positive test for active infection with novel coronavirus SARS-CoV-2019 was \>4 weeks prior to current admission.
Key Trial Info
Start Date :
April 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04359901
Start Date
April 10 2020
End Date
August 2 2021
Last Update
December 6 2023
Active Locations (5)
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1
VA Connecticut Healthcare System
West Haven, Connecticut, United States, 06516
2
VA Maine Healthcare System
Augusta, Maine, United States, 04330
3
VA Boston Healthcare System
Boston, Massachusetts, United States, 02132
4
Providence VA Medical Center
Providence, Rhode Island, United States, 02908