A Phase 4 interventional study of Sotrovimab in COVID-19, sponsored by GlaxoSmithKline. Completed at 8 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
Sotrovimab binds to a conserved epitope on the severe acute respiratory syndrome coronavirus (SARS-CoV) and SARS-CoV-2 spike protein outside the receptor-binding motif and has been shown to reduce the risk of hospitalization and/or death when administered as early treatment in non-hospitalized patients that are at risk for progression to severe disease. Immunocompromised (IC) patients are prioritized to receive early treatment for COVID-19 as they are at high risk of disease progression, and because of their potential for prolonged viral shedding and the resulting increased risk of emergent viral mutations and potential onward community transmission.
This genomic surveillance study will aim to describe changes in the SARS-CoV-2 spike protein observed in IC participants receiving sotrovimab as standard of clinical care in sentinel sites at a national level to assess potential emergence of viral variants.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 217 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites
Drug: Sotrovimab
Sotrovimab dose and administration per standard of clinical care
Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by Next generation sequencing (NGS) analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the amino acid (AA) sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 7.
Time frame: At Day 7
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 14.
Time frame: At Day 14
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 28.
Time frame: At Day 28
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 7.
Time frame: At Day 7
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 14.
Time frame: At Day 14
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 28.
Time frame: At Day 28
Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI)
SARS-CoV-2 VOC is defined by World health Organization(WHO) that meets definition of VUI and through a comparative assessment, has been demonstrated to be associated with 1 or more of following changes at degree of global public health(GPH) significance: increase in transmissibility or detrimental change in COVID-19 epidemiology, OR increase in virulence or change in clinical disease presentation, OR decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics. SARS-CoV-2 VUI is defined by WHO as a variant:with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune, diagnostic or therapeutic escape and identified to cause significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest emerging risk to GPH.
Time frame: Up to Day 28
Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
The number of participants that had undetectable viral load in nasal/oropharyngeal swabs was determined by quantitative reverse transcription-polymerase chain reaction (qRT/PCR) at Day 7, Day 14, and Day 28. Participants with major protocol deviation (out of visit window/samples received late/return more samples than expected) at specific visits were excluded from analysis.
Time frame: At Day 7, Day 14, and Day 28
Number of Participants With All Cause Hospital Stay
Number of participants hospitalized due to any cause have been reported.
Time frame: Up to Day 28
Number of Participants With COVID-19 Related Hospital Stay
Number of participants hospitalized due to COVID-19 have been reported.
Time frame: Up to Day 28
Number of Participants Requiring New or Increased Oxygen Support (Supplemental Oxygen [Not High Flow]), Non-invasive Ventilation or High-flow, Invasive Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Number of participants required new or increased oxygen support (supplemental oxygen \[not high flow\]), non-invasive ventilation or high-flow, invasive mechanical ventilation or ECMO have been reported.
Time frame: Up to Day 28
Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay
Number of participants hospitalized in ICU due to any cause have been reported.
Time frame: Up to Day 28
Number of Participants With COVID-19 Related ICU Hospital Stay
Number of participants hospitalized in ICU due to COVID-19 have been reported.
Time frame: Up to Day 28
Number of Participants Who Died Due to Any Cause Through Day 28
Data for number of participants who died due to any cause through Day 28 have been reported.
Time frame: Up to Day 28
Number of Participants Who Died Due to COVID-19 Through Day 28
Data for number of participants who died due to COVID-19 have been reported.
Time frame: Up to Day 28
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples above the threshold for the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the \>5% threshold for allelic frequency determination, AA changes in SARS-CoV-2 spike protein compared to Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.
Time frame: At Day 7, Day 14 and Day 28
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples with viral load above the threshold of the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the threshold for consensus sequence generation that were not present in the Baseline sequence, AA changes in the SARS-CoV-2 spike protein consensus sequence (\>50%) from Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.
Time frame: At Day 7, Day 14 and Day 28
This was a prospective cohort study amongst immunocompromised non-hospitalized participants treated with sotrovimab as part of standard clinical care to monitor the emergence of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) spike viral variants.
| Milestone | Sotrovimab 500 mg IV |
|---|---|
| Started | 217 |
| Completed | 208 |
| Not completed | 9 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Lost to follow-up | 4 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by Next generation sequencing (NGS) analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the amino acid (AA) sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 7.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| AA substitutions >5% allelic frequency | 38 |
| AA substitutions >50% allelic frequency | 12 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 14.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| AA substitutions >5% allelic frequency | 18 |
| AA substitutions >50% allelic frequency | 11 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The epitope is part of the spike protein, and it was analyzed separately from the rest of spike. The number of participants with TE substitutions in the sotrovimab epitope reflects participants that had a TE change in the spike protein at the sotrovimab epitope position only. AA substitutions compared to the reference strain are presented at Day 28.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| AA substitutions >5% allelic frequency | 11 |
| AA substitutions >50% allelic frequency | 11 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 7.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| AA substitutions >5% allelic frequency | 88 |
| AA substitutions >50% allelic frequency | 19 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 14.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| AA substitutions >5% allelic frequency | 37 |
| AA substitutions >50% allelic frequency | 17 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. Treatment emergent (TE) substitutions are defined as AA differences in a post-Baseline sample that were not present at Baseline at the defined threshold for minority and consensus analysis. The number of participants with TE substitutions in the spike protein reflects participants that had a TE change in the spike protein at any position including the sotrovimab epitope. AA substitutions compared to the reference strain are presented at Day 28.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| AA substitutions >5% allelic frequency | 20 |
| AA substitutions >50% allelic frequency | 13 |
SARS-CoV-2 VOC is defined by World health Organization(WHO) that meets definition of VUI and through a comparative assessment, has been demonstrated to be associated with 1 or more of following changes at degree of global public health(GPH) significance: increase in transmissibility or detrimental change in COVID-19 epidemiology, OR increase in virulence or change in clinical disease presentation, OR decrease in effectiveness of public health and social measures or available diagnostics, vaccines, therapeutics. SARS-CoV-2 VUI is defined by WHO as a variant:with genetic changes that are predicted or known to affect virus characteristics such as transmissibility, disease severity, immune, diagnostic or therapeutic escape and identified to cause significant community transmission or multiple COVID-19 clusters, in multiple countries with increasing relative prevalence alongside increasing number of cases over time, or other apparent epidemiological impacts to suggest emerging risk to GPH.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI) | 208 |
The number of participants that had undetectable viral load in nasal/oropharyngeal swabs was determined by quantitative reverse transcription-polymerase chain reaction (qRT/PCR) at Day 7, Day 14, and Day 28. Participants with major protocol deviation (out of visit window/samples received late/return more samples than expected) at specific visits were excluded from analysis.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Day 7 | 50 |
| Day 14 | 129 |
| Day 28 | 162 |
Number of participants hospitalized due to any cause have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants With All Cause Hospital Stay | 7 |
Number of participants hospitalized due to COVID-19 have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants With COVID-19 Related Hospital Stay | 0 |
Number of participants required new or increased oxygen support (supplemental oxygen \[not high flow\]), non-invasive ventilation or high-flow, invasive mechanical ventilation or ECMO have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| New or increased oxygen support (supplemental oxygen [not high flow]) | 1 |
| Non-invasive ventilation or high flow | 1 |
| Invasive mechanical ventilation | 0 |
| ECMO | 0 |
Number of participants hospitalized in ICU due to any cause have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay | 0 |
Number of participants hospitalized in ICU due to COVID-19 have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants With COVID-19 Related ICU Hospital Stay | 0 |
Data for number of participants who died due to any cause through Day 28 have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants Who Died Due to Any Cause Through Day 28 | 1 |
Data for number of participants who died due to COVID-19 have been reported.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Number of Participants Who Died Due to COVID-19 Through Day 28 | 0 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples above the threshold for the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the \>5% threshold for allelic frequency determination, AA changes in SARS-CoV-2 spike protein compared to Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Day 7, L5-L5F | 1 |
| Day 7, L5-L5F Frameshift mutation | 1 |
| Day 7, P39-P39L | 1 |
| Day 7, G75-G75C | 1 |
| Day 7, G75-G75V | 1 |
| Day 7, T95-T95I | 1 |
| Day 7, F106-F106 Deletion mutation | 1 |
| Day 7, Y144-Y144 Deletion mutation | 1 |
| Day 7, H146-H146Q Frameshift mutation | 1 |
| Day 7, V320-V320A | 1 |
| Day 7, P330-P330S | 2 |
| Day 7, P337-P337A | 2 |
| Day 7, P337-P337H | 2 |
| Day 7, P337-P337L | 8 |
| Day 7, P337-P337R | 2 |
| Day 7, P337-P337S | 14 |
| Day 7, G339-G339R | 1 |
| Day 7, G339-G339Y | 1 |
| Day 7, E340-E340A | 3 |
| Day 7, E340-E340D | 15 |
| Day 7, E340-E340G | 5 |
| Day 7, E340-E340K | 6 |
| Day 7, E340-E340Q | 14 |
| Day 7, E340-E340V | 2 |
| Day 7, K356-K356M | 1 |
| Day 7, K356-K356R | 1 |
| Day 7, K356-K356T | 6 |
| Day 7, S373-S373P | 1 |
| Day 7, Q474-Q474 Deletion mutation | 1 |
| Day 7, Q493-Q493K | 1 |
| Day 7, G496-G496V | 1 |
| Day 7, V503-V503F | 1 |
| Day 7, L517-L517F | 1 |
| Day 7, L517-L517P | 1 |
| Day 7, T523-T523I | 1 |
| Day 7, F543-F543L | 1 |
| Day 7, T547-T547K | 1 |
| Day 7, K558-K558 Deletion mutation | 1 |
| Day 7, A570-A570T | 1 |
| Day 7, T572-T572I | 1 |
| Day 7, P579-P579L | 1 |
| Day 7, L585-L585F | 1 |
| Day 7, C590-C590Y | 1 |
| Day 7, F592-F592 Deletion mutation | 1 |
| Day 7, V622-V622I | 1 |
| Day 7, H625- H625N | 1 |
| Day 7, S640-S640F | 1 |
| Day 7, Y660-Y660H | 2 |
| Day 7, I666- I666 Deletion mutation | 1 |
| Day 7, G667-G667 Deletion mutation | 1 |
| Day 7, A668-A668 Deletion mutation | 1 |
| Day 7, G669-G669 Deletion mutation | 1 |
| Day 7, I670-I670 Deletion mutation | 1 |
| Day 7, C671-C671 Deletion mutation | 1 |
| Day 7, A672-A672 Deletion mutation | 1 |
| Day 7, S673-S673 Deletion mutation | 1 |
| Day 7, Y674-Y674 Deletion mutation | 1 |
| Day 7, Q675-Q675H | 1 |
| Day 7, L752-L752F | 1 |
| Day 7, N777-N777 Deletion mutation | 2 |
| Day 7, I794-I794T | 1 |
| Day 7, L822-L822 Deletion mutation | 1 |
| Day 7, L822-L822F | 1 |
| Day 7, F823-F823 Deletion mutation | 1 |
| Day 7, A845-A845V | 1 |
| Day 7, A846-A846T | 1 |
| Day 7, A846-A846V | 1 |
| Day 7, I850-I850T | 1 |
| Day 7, P862-P862S | 1 |
| Day 7, Q913-Q913 Stop codon mutation | 1 |
| Day 7, A930-A930 Deletion mutation | 1 |
| Day 7, Q954-Q954Y | 1 |
| Day 7, F970-F970L | 1 |
| Day 7, S974-S974L | 1 |
| Day 7, V987-V987F | 1 |
| Day 7, A989-A989V | 1 |
| Day 7, K1038-K1038E | 1 |
| Day 7, C1043-C1043 Deletion mutation | 1 |
| Day 7, H1048-H1048Y | 1 |
| Day 7, L1049-L1049F | 2 |
| Day 7, P1053-P1053S | 1 |
| Day 7, H1058-H1058Y | 1 |
| Day 7, V1060-V1060I | 1 |
| Day 7, F1103-F1103S | 1 |
| Day 7, I1130-I1130L | 1 |
| Day 7, D1146-D1146H | 1 |
| Day 7, Q1208-Q1208 Stop codon mutation | 1 |
| Day 7, Q1208-Q1208H | 1 |
| Day 7, W1214-W1214C | 1 |
| Day 7, F1220-F1220 Deletion mutation | 1 |
| Day 7, C1254-C1254 Stop codon mutation | 20 |
| Day 7, E1258-E1258H | 1 |
| Day 7, E1258-E1258Q | 1 |
| Day 7, P1263-P1263L | 1 |
| Day 14, L5-L5F | 1 |
| Day 14, L5-L5 Frameshift mutation | 1 |
| Day 14, C15-C15F | 1 |
| Day 14, Q23-Q23 Stop codon mutation | 1 |
| Day 14, A67-A67V | 1 |
| Day 14, F79-F79 Deletion mutation | 1 |
| Day 14, D88-D88G | 1 |
| Day 14, E132-E132 Deletion mutation | 1 |
| Day 14, F133-F133 Deletion mutation | 1 |
| Day 14, D138-D138Y | 1 |
| Day 14, P139-P139 Deletion mutation | 2 |
| Day 14, F140-F140 Deletion mutation | 2 |
| Day 14, L141-L141 Deletion mutation | 2 |
| Day 14, G142-G142 Deletion mutation | 2 |
| Day 14, V143-V143 Deletion mutation | 2 |
| Day 14, Y144-Y144 Deletion mutation | 3 |
| Day 14, Y145-Y145 Deletion mutation | 1 |
| Day 14, H146-H146 Deletion mutation | 1 |
| Day 14, H146-H146Y | 1 |
| Day 14, W152-W152L | 1 |
| Day 14, M153-M153I | 1 |
| Day 14, A243-A243 Deletion mutation | 1 |
| Day 14, L244-L244 Deletion mutation | 1 |
| Day 14, P337-P337H | 1 |
| Day 14, P337-P337L | 4 |
| Day 14, P337-P337R | 1 |
| Day 14, P337-P337S | 6 |
| Day 14, E340-E340D | 5 |
| Day 14, E340-E340G | 4 |
| Day 14, E340-E340K | 5 |
| Day 14, E340-E340Q | 7 |
| Day 14, E340-E340V | 2 |
| Day 14, R346-R346T | 1 |
| Day 14, K356-K356T | 1 |
| Day 14, T376-T376 Deletion mutation | 1 |
| Day 14, F377-F377 Deletion mutation | 1 |
| Day 14, K444-K444S | 1 |
| Day 14, V503-V503A | 1 |
| Day 14, Y505-Y505N | 1 |
| Day 14, R509-R509T | 1 |
| Day 14, K528-K528E | 1 |
| Day 14, T547-T547K | 1 |
| Day 14, A570-A570T | 1 |
| Day 14, T572-T572I | 1 |
| Day 14, D574-D574N | 1 |
| Day 14, L611-L611P | 1 |
| Day 14, G639-G639V | 1 |
| Day 14, G669-G669 Deletion mutation | 1 |
| Day 14, I670-I670N | 1 |
| Day 14, C671-C671 Deletion mutation | 1 |
| Day 14, A672-A672 Deletion mutation | 1 |
| Day 14, S673-S673 Deletion mutation | 1 |
| Day 14, Y674-Y674 Deletion mutation | 1 |
| Day 14, Q675-Q675H | 1 |
| Day 14, A694-A694S | 1 |
| Day 14, T859-T859 Deletion mutation | 1 |
| Day 14, V860-V860 Deletion mutation | 1 |
| Day 14, A879-A879V | 1 |
| Day 14, A893-A893S | 1 |
| Day 14, K921-K921 Deletion mutation | 1 |
| Day 14, V951-V951L | 1 |
| Day 14, A956-A956E | 1 |
| Day 14, V987-V987F | 1 |
| Day 14, R1019-R1019I Frameshift mutation | 1 |
| Day 14, Y1067-Y1067H | 1 |
| Day 14, F1089-F1089S | 1 |
| Day 14, F1095-F1095L | 1 |
| Day 14, E1150-E1150G | 1 |
| Day 14, M1229-M1229I | 1 |
| Day 14, L1244-L1244 Deletion mutation | 1 |
| Day 14, K1245-K1245 Stop codon mutation | 1 |
| Day 14, C1254-C1254 Stop codon mutation | 7 |
| Day 28, F32-F32 Deletion mutation | 1 |
| Day 28, R78-R78S | 1 |
| Day 28, F133-F133S | 1 |
| Day 28, D138-D138Y | 1 |
| Day 28, P139-P139 Deletion mutation | 1 |
| Day 28, F140-F140 Deletion mutation | 1 |
| Day 28, L141-L141 Deletion mutation | 1 |
| Day 28, G142-G142 Deletion mutation | 1 |
| Day 28, V143-V143 Deletion mutation | 1 |
| Day 28, Y144-Y144 Deletion mutation | 5 |
| Day 28, Y145-Y145 Deletion mutation | 1 |
| Day 28, H146-H146 Deletion mutation | 1 |
| Day 28, N148-N148 Deletion mutation | 1 |
| Day 28, I210-I210N | 1 |
| Day 28, N211-N211 Deletion mutation | 1 |
| Day 28, P330-P330S | 1 |
| Day 28, P337-P337H | 1 |
| Day 28, P337-P337S | 2 |
| Day 28, E340-E340A | 1 |
| Day 28, E340-E340D | 1 |
| Day 28, E340-E340G | 2 |
| Day 28, E340-E340K | 1 |
| Day 28, E340-E340Q | 4 |
| Day 28, E340-E340V | 2 |
| Day 28, K356-K356R | 1 |
| Day 28, K356-K356T | 1 |
| Day 28, T376-T376 Deletion mutation | 1 |
| Day 28, F377-F377 Deletion mutation | 1 |
| Day 28, D420-D420N | 1 |
| Day 28, G446-G446D | 1 |
| Day 28, G446-G446R | 1 |
| Day 28, G476-G476R | 1 |
| Day 28, N481-N481K | 1 |
| Day 28, Y489-Y489H | 1 |
| Day 28, G496-G496V | 1 |
| Day 28, Y505-Y505N | 1 |
| Day 28, L513-L513F | 1 |
| Day 28, L517-L517F | 1 |
| Day 28, T547-T547K | 1 |
| Day 28, T572-T572I | 1 |
| Day 28, S591-S591F | 1 |
| Day 28, G593-G593V | 1 |
| Day 28, P631-P631S | 1 |
| Day 28, Q644-Q644 Frameshift mutation | 1 |
| Day 28, A647-A647S | 1 |
| Day 28, Q675-Q675H | 1 |
| Day 28, T676-T676I | 1 |
| Day 28, K795-K795 Deletion mutation | 1 |
| Day 28, Q872-Q872 Stop codon mutation | 1 |
| Day 28, T883-T883I | 1 |
| Day 28, A899-A899C Frameshift mutation | 1 |
| Day 28, D979-D979V | 1 |
| Day 28, V987-V987F | 1 |
| Day 28, Q1002-Q1002 Stop codon mutation | 1 |
| Day 28, A1020-A1020V | 1 |
| Day 28, H1048-H1048Y | 1 |
| Day 28, F1103-F1103V | 1 |
| Day 28, T1117-T1117I | 1 |
| Day 28, S1123-S1123P | 1 |
| Day 28, I1227-I1227 Deletion mutation | 1 |
| Day 28, C1254-C1254 Stop codon mutation | 5 |
SARS-CoV-2 spike analysis was carried out by nucleotide sequencing of the SARS-CoV-2 spike protein by NGS analysis of participant nasal/oropharyngeal swab samples for samples with viral load above the threshold of the sequencing assay. The nucleotide sequences were translated, and the AA sequences aligned and compared to a reference sequence. For samples with AA changes above the threshold for consensus sequence generation that were not present in the Baseline sequence, AA changes in the SARS-CoV-2 spike protein consensus sequence (\>50%) from Baseline was reported. One participant may have more than one substitution under the same codon. Treatment Emergent Substitutions included participants where a Baseline and post-Baseline records exist. All type of AA mutations have been categorized.
| Participants | Sotrovimab 500 mg IV |
|---|---|
| Day 7, G75-G75V | 1 |
| Day 7, P337-P337L | 1 |
| Day 7, P337-P337S | 3 |
| Day 7, E340-E340A | 1 |
| Day 7, E340-E340D | 2 |
| Day 7, E340-E340G | 1 |
| Day 7, E340-E340K | 1 |
| Day 7, E340-E340Q | 3 |
| Day 7, S373-S373P | 1 |
| Day 7, Q675-Q675H | 1 |
| Day 7, L752-L752F | 1 |
| Day 7, A845-A845V | 1 |
| Day 7, A846-A846T | 1 |
| Day 7, Q913-Q913 Stop codon mutation | 1 |
| Day 7, P1053-P1053S | 1 |
| Day 14, L5-L5F | 1 |
| Day 14, Y144-Y144 Deletion mutation | 1 |
| Day 14, P337-P337L | 1 |
| Day 14, P337-P337S | 1 |
| Day 14, E340-E340D | 3 |
| Day 14, E340-E340K | 1 |
| Day 14, E340-E340Q | 3 |
| Day 14, E340-E340V | 1 |
| Day 14, K356-K356T | 1 |
| Day 14, V503-V503A | 1 |
| Day 14, Y505-Y505N | 1 |
| Day 14, A570-A570T | 1 |
| Day 14, T572-T572I | 1 |
| Day 14, D574-D574N | 1 |
| Day 14, I670- I670N | 1 |
| Day 14, C671-C671 Deletion mutation | 1 |
| Day 14, A672-A672 Deletion mutation | 1 |
| Day 14, S673-S673 Deletion mutation | 1 |
| Day 14, Y674-Y674 Deletion mutation | 1 |
| Day 14, A956-A956E | 1 |
| Day 14, L1244-L1244 Deletion mutation | 1 |
| Day 28, Y144-Y144 Deletion mutation | 3 |
| Day 28, I210-I210N | 1 |
| Day 28, N211-N211 Deletion mutation | 1 |
| Day 28, P337-P337S | 2 |
| Day 28, E340-E340A | 1 |
| Day 28, E340-E340D | 1 |
| Day 28, E340-E340G | 1 |
| Day 28, E340-E340K | 1 |
| Day 28, E340-E340Q | 3 |
| Day 28, E340-E340V | 1 |
| Day 28, K356-K356R | 1 |
| Day 28, D420-D420N | 1 |
| Day 28, G446-G446D | 1 |
| Day 28, N481-N481K | 1 |
| Day 28, T572-T572I | 1 |
| Day 28, P631-P631S | 1 |
| Day 28, A647-A647S | 1 |
| Day 28, T676-T676I | 1 |
| Day 28, Q1002-Q1002 Stop codon mutation | 1 |
Collected over Up to Day 28. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sotrovimab 500 mg IV | 1/217 (0.5%) | 0/217 (0%) | 6/217 (2.8%) |
| Event | Sotrovimab 500 mg IV |
|---|---|
| DiarrhoeaGastrointestinal disorders | 1/217 |
| Blood creatinine increasedInvestigations | 1/217 |
| Neutrophil count increasedInvestigations | 1/217 |
| White blood cell count increasedInvestigations | 1/217 |
| AgeusiaNervous system disorders | 1/217 |
| AnosmiaNervous system disorders | 1/217 |
| HeadacheNervous system disorders | 1/217 |
| PruritusSkin and subcutaneous tissue disorders | 1/217 |
| Age, Continuous(Years) | Sotrovimab 500 mg IV |
|---|---|
| Mean | 56.5 ± 15.66 |
| Sex: Female, Male(Participants) | Sotrovimab 500 mg IV |
|---|---|
| Female | 123 |
| Male | 94 |
| Race/Ethnicity, Customized(Participants) | Sotrovimab 500 mg IV |
|---|---|
| White | 49 |
| White - White/Caucasian/European Heritage | 139 |
| De-identified | 29 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Supporting information: Study protocol, Sap, Icf, Csr
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