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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving Sotrovimab | Experimental | Immunocompromised non-hospitalized participants will receive sotrovimab as standard of clinical care for COVID-19 in sentinel sites |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotrovimab | Drug | Sotrovimab dose and administration per standard of clinical care |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Cambridge | CB2 0QQ | United Kingdom | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35780162 | Background | Case JB, Mackin S, Errico JM, Chong Z, Madden EA, Whitener B, Guarino B, Schmid MA, Rosenthal K, Ren K, Dang HV, Snell G, Jung A, Droit L, Handley SA, Halfmann PJ, Kawaoka Y, Crowe JE Jr, Fremont DH, Virgin HW, Loo YM, Esser MT, Purcell LA, Corti D, Diamond MS. Resilience of S309 and AZD7442 monoclonal antibody treatments against infection by SARS-CoV-2 Omicron lineage strains. Nat Commun. 2022 Jul 2;13(1):3824. doi: 10.1038/s41467-022-31615-7. |
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IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
A total of 217 participants were enrolled in this study.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sotrovimab 500 mg IV | Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 24, 2023 | Jul 10, 2024 |
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This study is a prospective cohort study which will enroll IC non-hospitalized participants receiving sotrovimab treatment as per standard of clinical care for COVID-19 in sentinel sites.
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| 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. | 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. | 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. | At Day 28 |
| 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. | 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. | Up to Day 28 |
| Number of Participants With COVID-19 Related Hospital Stay | Number of participants hospitalized due to COVID-19 have been reported. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | At Day 7, Day 14 and Day 28 |
| Cardiff |
| CF14 4XW |
| United Kingdom |
| GSK Investigational Site | EdgbastonBirmingham | B15 2GW | United Kingdom |
| GSK Investigational Site | London | NW1 2BU | United Kingdom |
| GSK Investigational Site | London | SE1 7EH | United Kingdom |
| GSK Investigational Site | Middlesbrough | TS4 3BW | United Kingdom |
| GSK Investigational Site | Newcastle upon Tyne | NE1 4LP | United Kingdom |
| GSK Investigational Site | Plymouth | PL6 5FP | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sotrovimab 500 mg IV | Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Few race categories (with 0\ | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | At Day 7 |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | At Day 14 |
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | At Day 28 |
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | At Day 7 |
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | At Day 14 |
| |||||||||||||||||||||||||||||||||||
| Primary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants with Paired Sequences were included in the analysis. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Count of Participants | Participants | At Day 28 |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. Number of participants with any VOC/VUI based on WHO classification and Pango sub-lineage for the earliest possible VOC/VUI sample has been presented. | Posted | Count of Participants | Participants | Up to Day 28 |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention, and represents the Overall Number of Participants Analyzed field (i.e., contributed data reported in the table). 'Number Analyzed' signifies participants evaluable for the specified time points. | Posted | Count of Participants | Participants | At Day 7, Day 14, and Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With All Cause Hospital Stay | Number of participants hospitalized due to any cause have been reported. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With COVID-19 Related Hospital Stay | Number of participants hospitalized due to COVID-19 have been reported. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With COVID-19 Related ICU Hospital Stay | Number of participants hospitalized in ICU due to COVID-19 have been reported. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. | Posted | Count of Participants | Participants | Up to Day 28 |
|
| ||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field, and represents participants who had Baseline and post-Baseline sequence available. 'Number Analyzed' signifies participants evaluable for the specified time points and codons at the >5% allelic frequency. | Posted | Count of Participants | Participants | At Day 7, Day 14 and Day 28 |
| |||||||||||||||||||||||||||||||||||
| Secondary | 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. | The Safety Set included all participants who were enrolled and exposed to study intervention. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field, and represents participants who had Baseline and post-Baseline sequence available. 'Number Analyzed' signifies participants evaluable for the specified time points and codons at the >50% allelic frequency. | Posted | Count of Participants | Participants | At Day 7, Day 14 and Day 28 |
|
Up to Day 28
All-cause mortality, Treatment-emergent serious adverse events (TESAEs) and Treatment-emergent non-SAEs were reported for the Safety Set (Safety Set included all participants who were enrolled and exposed to study intervention).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sotrovimab 500 mg IV | Immunocompromised non-hospitalized participants were treated with sotrovimab 500 milligram (mg) intravenously (IV) as a standard of clinical care for Coronavirus Disease 2019 (COVID-19). | 1 | 217 | 0 | 217 | 6 | 217 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Neutrophil count increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA version 26.0 | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Anosmia | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA version 26.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 26.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2023 | Jul 10, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000711967 | sotrovimab |
Not provided
Not provided
Not provided
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