Study to monitor the occurrence of viral variants in patients with compromised immune systems being treated for COVID-19

Not Applicable

• Conditions: COVID-19 (SARS-CoV-2 infection); Infections and Infestations

• Registration Number: ISRCTN74418247
• Lead Sponsor: GlaxoSmithKline (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-24
• Last Update Posted: 20 June 2022
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

Exclusion Criteria

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Proportion of patients eligible for sequence analysis that have any amino acid change from baseline in the epitope of sotrovimab binding measured using RT-PCR on samples collected on days 7, 14 and 28 (+/-2 days)<br> 2. Proportion of patients eligible for sequence analysis that have any amino acid change from baseline in the spike protein measured using RT-PCR on samples collected on days 7, 14 and 28 (+/-2 days)<br>