Subcutaneous sarilumab for the treatment of hospitalized patients with moderate to severe COVID19 disease: A pragmatic, embedded randomized clinical trial.

ABSTRACT:

Importance and objective

The aim of this pragmatic, embedded, adaptive trial was to measure the effectiveness of the subcutaneous anti-IL-6R antibody sarilumab, when added to an evolving standard of care (SOC), for clinical management of inpatients with moderate to severe COVID-19 disease.

Design

Two-arm, randomized, open-label controlled trial comparing SOC alone to SOC plus sarilumab. The trial used a randomized play-the-winner design and was fully embedded within the electronic health record (EHR) system.

Setting

5 VA Medical Centers.

Participants

Hospitalized patients with clinical criteria for moderate to severe COVID-19 but not requiring mechanical ventilation, and a diagnostic test positive for SARS-CoV-2.

Interventions

Sarilumab, 200 or 400 mg su

SUBMITTER: Branch-Elliman W 

PROVIDER: S-EPMC8880885 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature