Study to monitor the occurrence of viral variants in patients with compromised immune systems being treated for COVID-19
| ISRCTN | ISRCTN74418247 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74418247 |
| EudraCT/CTIS number | 2022-000754-29 |
| IRAS number | 1005346 |
| Secondary identifying numbers | 218407, IRAS 1005346, CPMS 52127 |
- Submission date
- 18/03/2022
- Registration date
- 24/05/2022
- Last edited
- 06/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid, and make it more difficult to breathe.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19 include people who have long-term health conditions and a weakened immune system (often referred to as immunocompromised). The aim of this study is to gather clinical information about sotrovimab after it is given to immunocompromised patients who have tested positive for COVID-19. Specifically, the study is looking for clearance of the virus and, if not cleared, for the appearance of any genetic changes (mutations) in the virus following sotrovimab treatment. This medication is already approved by the MHRA (UK’s Health Authority) and is available to treat patients in UK NHS facilities. Sotrovimab is also known by the brand name Xevudy. It has already been established in previous research that sotrovimab helps the body to fight COVID-19 infection. There will be about 10 NHS sites in Great Britain taking part in the study and a total of 500 patients are expected to be enrolled.
Who can participate?
Any immunocompromised patients aged 18 years and over who have tested positive for COVID-19, who are not currently hospitalised, and who have been prescribed sotrovimab treatment as part of usual care.
What does the study involve?
Patients whose doctor has decided to treat their infection with sotrovimab and who also meet the eligibility criteria for the study will be asked to consent to join the study. Once they are enrolled in the study, they will be asked to provide nasal and throat swabs and provide information on their health, medical history, vaccination status and their COVID-19 infection at four visits. The first visit will be at the time of sotrovimab treatment administration (baseline visit) and then there are three follow-up visits which will be conducted via telephone with swabs being taken by the patient and posted to the study laboratory for analysis.
What are the possible benefits and risks of participating?
The study procedures that are not part of usual care for COVID-19 (i.e. are only being done for the study) are the four nose and throat samples. There is minimal risk from these procedures, but patients may experience some discomfort during or after the nose and throat are swabbed for sample collection.
Where is the study run from?
The study will run in UK NHS sites which are also Covid Medicines Delivery Units and are therefore able to administer sotrovimab as part of usual care.
When is the study starting and how long is it expected to run for?
March 2022 to May 2023
Who is funding the study?
GlaxoSmithKline (UK)
Who is the main contact?
1. Dr David Lowe, d.lowe@ucl.ac.uk
2. Dr Myriam Drysdale, myriam.g.drysdale@gsk.com
Contact information
Scientific
UCL Institute of Immunity & Transplantation
The Pears Building
Pond Street
London
NW3 2PP
United Kingdom
| Phone | +44 (0)20 7794 0500 x34906 |
|---|---|
| d.lowe@ucl.ac.uk |
Scientific
GSK
980 Great West Rd
Brentford
TW8 9GS
United Kingdom
| Phone | +44 (0)20 8047 5000 |
|---|---|
| myriam.g.drysdale@gsk.com |
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | 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 |
| Study acronym | LUNAR |
| Study objectives | 1. Evaluate the proportion of patients eligible for sequence analysis that have any amino acid (AA) change from baseline in the epitope of sotrovimab binding in samples collected at Day 7, 14 and 28 (+/-2 days) 2. Evaluate the proportion of patients eligible for sequence analysis that have any AA change from baseline in the spike protein in samples collected at Day 7, 14 and 28 (+/-2 days) 1. Evaluate the proportion of patients eligible for sequence analysis with variants of concern (VOC) and under investigation (VUI) on the earliest possible sample including baseline 2. Evaluate the proportion of patients with undetectable virus at Day 7, 14 and 28 (+/-2 days) by RT-PCR 3. Evaluate the proportion of patients with key clinical outcomes(hospital admission, requirement for respiratory support, intensive care unit [ICU] admission and death) through Day 28 post sotrovimab administration 4. Describe amino acid (AA) (detected at >5% allelic frequency)changes in the SARS-CoV-2 spike protein in samples collected at Day 7,14 and 28 (+/-2 days) compared to baseline following sotrovimab administration for samples with viral loads above the threshold of the sequencing assay 5. Describe AA changes in the consensus sequence (>50%) of SARS-CoV-2 spike protein in samples collected at Day 7, 14 and 28 (+/-2 days) compared to baseline following sotrovimab administration |
| Ethics approval(s) | Approved 12/05/2022, South Central - Oxford B Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square Bristol BS1 6PN, UK; +44 (0)207 104 8360; oxfordb.rec@hra.nhs.uk), ref: 22/SC/0099 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | 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). The total duration is about 4 weeks. Concomitant medications, vaccination status and clinical outcome (i.e. including hospital admission, respiratory support, ICU admission and death ) will be collected on day 0 at site and days 7, 14 and 28 during follow-up calls. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Sotrovimab |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 16/03/2022 |
| Completion date | 31/05/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 219 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 21/06/2022 |
| Date of final enrolment | 12/05/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Middlesbrough
TS4 3BW
United Kingdom
Great Maze Pond
London
SE1 9RT
United Kingdom
117 Suttons Lane
Hornchurch
RM12 6RS
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Glasgow
G12 0XH
United Kingdom
Newcastle upon Tyne
TS1 4LP
United Kingdom
Sponsor information
Industry
GlaxoSmithKline UK Limited
980 Great West Road
Brentford
Brentford
TW8 9GS
England
United Kingdom
| Phone | +44 (0)20 8047 5000 |
|---|---|
| oax52639@gsk.com | |
| Website | http://uk.gsk.com/ |
"ROR" |
https://ror.org/01xsqw823 |
Funders
Funder type
Industry
Government organisation / For-profit companies (industry)
- Alternative name(s)
- GlaxoSmithKline plc., GSK plc., GSK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | 1. Peer-reviewed scientific journals 2. Internal report 3. Conference presentation 4. Publication on website 5. Other publication 6. Submission to regulatory authorities 7. Access to raw data and right to publish freely by all investigators in study or by Independent Steering Committee on behalf of all investigators 8. Study report |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 19/05/2025 | 06/06/2025 | Yes | No |
Editorial Notes
06/06/2025: Publication reference and total final enrolment added.
07/06/2022: Internal review.
13/05/2022: ISRCTN received notification of combined HRA/MHRA approval for this trial on 13/05/2022.
18/03/2022: Trial's existence confirmed by the HRA.
