COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
Patients will have their first nasal/oropharyngeal swab at the site on the day they receive sotrovimab (D0) and will be provided with three home test kits to complete on days 7, 14 and 28 (+/-2 days).
Sponsors
GlaxoSmithKline (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients eligible for sequence analysis with VOC and VUI on the earliest possible sample including baseline measured using RT-PCR and sequencing methods at baseline and later timepoints on days 7, 14 and 28 (+/-2 days) if baseline samples can’t be analysed 2. Proportion of patients with undetectable virus measured using RT-PCR on days 7, 14 and 28 (+/-2 days) 3. Clinical outcomes measured on days 7, 14 and through 28 (+/-2 days): 3.1. Proportion of patients that are admitted to hospital for any cause and for COVID-19 reasons measured using electronic health records and medical charts through 28 days 3.2. Proportion of patients requiring new or increased oxygen support measured using electronic health records and medical charts through 28 days 3.3. Proportion of patients requiring invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) measured using electronic health records and medical charts through 28 days 3.4. Proportion of all-cause ICU admission measured using electronic health records and medical charts through 28 days | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed