Prospective cohort study to monitor the emergence of SARS-CoV-2 spike viral variants in immunocompromised non-hospitalised patients exposed to sotrovimab in Great Britain: the LUNAR study

GlaxoSmithKline (United Kingdom)0 sites500 target enrollmentMay 24, 2022

Overview

No summary available.

Registry

who.int

Start Date

May 24, 2022

End Date

May 31, 2023

Last Updated

3 years ago

Study Type

Interventional

Sex

All

Sponsor

GlaxoSmithKline (United Kingdom)

•1\. Adult patients \=18 years old
•2\. Immunocompromised (as defined in the clinical commissioning policy \[MHRA, 2022])
•3\. A positive PCR or antigen test for SARS\-CoV\-2 through clinical testing or routine screening undertaken as part of clinical management
•4\. Prescribed treatment with sotrovimab as standard of clinical care
•5\. Able to provide informed consent and willing to adhere to study\-related procedures

•1\. Patients who require hospitalisation (related or not to COVID\-19\) at baseline
•2\. Patients who initiated sotrovimab therapy in in\-patient settings
•3\. Patients unable to perform follow\-up sample collection
•4\. Blinded patients from other COVID\-19 related trials
•From the Clinical Commissioning Policy, the following groups will also be excluded from this study unless also eligible for sotrovimab under other Clinical Commissioning Policy IC criteria not listed below \[MHRA, 2022]:
•5\. Cohort of patients with rare neurological conditions
•6\. Cohort of patients with Down's syndrome
•7\. In the cohort of patients with renal disease: patients with chronic kidney stage (CKD) 4 or 5 (an eGFR less than 30 ml/min/1\.73 m²) without immunosuppression (patients with renal disease cohort)
•8\. In the cohort of patients with liver disease: patients with cirrhosis Child's\-Pugh class A who are not on immunosuppressive therapy (compensated liver disease), class B or class C (decompensated liver disease)