Trial Outcomes & Findings for Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19 (NCT NCT05305651)
NCT ID: NCT05305651
Last Updated: 2024-10-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
217 participants
Primary outcome timeframe
At Day 7
Results posted on
2024-10-15
Participant Flow
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.
A total of 217 participants were enrolled in this study.
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
217
|
|
Overall Study
COMPLETED
|
208
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Death
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
4
|
Baseline Characteristics
Study to Monitor the Occurrence of Viral Variants in Patients With Compromised Immune Systems Being Treated for COVID-19
Baseline characteristics by cohort
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Age, Continuous
|
56.5 Years
STANDARD_DEVIATION 15.66 • n=5 Participants
|
|
Sex: Female, Male
Female
|
123 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White - White/Caucasian/European Heritage
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
De-identified
|
29 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=153 Participants
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).
|
|---|---|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7
AA substitutions >5% allelic frequency
|
38 Participants
|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions Greater Than (>) 5 Percent (%) and >50% Allelic Frequency in the Sotrovimab Epitope at Day 7
AA substitutions >50% allelic frequency
|
12 Participants
|
PRIMARY outcome
Timeframe: At Day 14Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=71 Participants
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).
|
|---|---|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14
AA substitutions >5% allelic frequency
|
18 Participants
|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 14
AA substitutions >50% allelic frequency
|
11 Participants
|
PRIMARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=33 Participants
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).
|
|---|---|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28
AA substitutions >5% allelic frequency
|
11 Participants
|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Sotrovimab Epitope at Day 28
AA substitutions >50% allelic frequency
|
11 Participants
|
PRIMARY outcome
Timeframe: At Day 7Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=153 Participants
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).
|
|---|---|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7
AA substitutions >5% allelic frequency
|
88 Participants
|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 7
AA substitutions >50% allelic frequency
|
19 Participants
|
PRIMARY outcome
Timeframe: At Day 14Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=71 Participants
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).
|
|---|---|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14
AA substitutions >5% allelic frequency
|
37 Participants
|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 14
AA substitutions >50% allelic frequency
|
17 Participants
|
PRIMARY outcome
Timeframe: At Day 28Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=33 Participants
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).
|
|---|---|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28
AA substitutions >5% allelic frequency
|
20 Participants
|
|
Number of Participants With Treatment Emergent Amino Acid Substitutions >5% and >50% Allelic Frequency in the Spike Protein at Day 28
AA substitutions >50% allelic frequency
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=208 Participants
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).
|
|---|---|
|
Number of Participants With Variants of Concern (VOC) or Variants Under Investigation (VUI)
|
208 Participants
|
SECONDARY outcome
Timeframe: At Day 7, Day 14, and Day 28Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Day 7
|
50 Participants
|
|
Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Day 14
|
129 Participants
|
|
Number of Participants With Undetectable Virus by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
Day 28
|
162 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
Number of participants hospitalized due to any cause have been reported.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants With All Cause Hospital Stay
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
Number of participants hospitalized due to COVID-19 have been reported.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants With COVID-19 Related Hospital Stay
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
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)
New or increased oxygen support (supplemental oxygen [not high flow])
|
1 Participants
|
|
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)
Non-invasive ventilation or high flow
|
1 Participants
|
|
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)
Invasive mechanical ventilation
|
0 Participants
|
|
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)
ECMO
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
Number of participants hospitalized in ICU due to any cause have been reported.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants With All Cause Intensive Care Unit (ICU) Hospital Stay
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
Number of participants hospitalized in ICU due to COVID-19 have been reported.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants With COVID-19 Related ICU Hospital Stay
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
Data for number of participants who died due to any cause through Day 28 have been reported.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants Who Died Due to Any Cause Through Day 28
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to Day 28Population: The Safety Set included all participants who were enrolled and exposed to study intervention.
Data for number of participants who died due to COVID-19 have been reported.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=217 Participants
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).
|
|---|---|
|
Number of Participants Who Died Due to COVID-19 Through Day 28
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 7, Day 14 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=156 Participants
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).
|
|---|---|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, F140-F140 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L5-L5F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L5-L5F Frameshift mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P39-P39L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G75-G75C
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G75-G75V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, T95-T95I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F106-F106 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Y144-Y144 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, H146-H146Q Frameshift mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, V320-V320A
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P330-P330S
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P337-P337A
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P337-P337H
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P337-P337L
|
8 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P337-P337R
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P337-P337S
|
14 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G339-G339R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G339-G339Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E340-E340A
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E340-E340D
|
15 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E340-E340G
|
5 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E340-E340K
|
6 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E340-E340Q
|
14 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E340-E340V
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, K356-K356M
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, K356-K356R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, K356-K356T
|
6 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, S373-S373P
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q474-Q474 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q493-Q493K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G496-G496V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, V503-V503F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L517-L517F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L517-L517P
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, T523-T523I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F543-F543L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, T547-T547K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, K558-K558 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A570-A570T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, T572-T572I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P579-P579L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L585-L585F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, C590-C590Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F592-F592 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, V622-V622I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, H625- H625N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, S640-S640F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Y660-Y660H
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, I666- I666 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G667-G667 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A668-A668 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, G669-G669 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, I670-I670 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, C671-C671 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A672-A672 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, S673-S673 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Y674-Y674 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q675-Q675H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L752-L752F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, N777-N777 Deletion mutation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, I794-I794T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L822-L822 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L822-L822F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F823-F823 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A845-A845V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A846-A846T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A846-A846V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, I850-I850T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P862-P862S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q913-Q913 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A930-A930 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q954-Q954Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F970-F970L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, S974-S974L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, V987-V987F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, A989-A989V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, K1038-K1038E
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, C1043-C1043 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, H1048-H1048Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, L1049-L1049F
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P1053-P1053S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, H1058-H1058Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, V1060-V1060I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F1103-F1103S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, I1130-I1130L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, D1146-D1146H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q1208-Q1208 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, S1123-S1123P
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, Q1208-Q1208H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, W1214-W1214C
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, F1220-F1220 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, C1254-C1254 Stop codon mutation
|
20 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E1258-E1258H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, E1258-E1258Q
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 7, P1263-P1263L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, L5-L5F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, L5-L5 Frameshift mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, C15-C15F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Q23-Q23 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A67-A67V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, F79-F79 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, D88-D88G
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E132-E132 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, F133-F133 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, D138-D138Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, P139-P139 Deletion mutation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, F140-F140 Deletion mutation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, L141-L141 Deletion mutation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, G142-G142 Deletion mutation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, V143-V143 Deletion mutation
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Y144-Y144 Deletion mutation
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Y145-Y145 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, H146-H146 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, H146-H146Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, W152-W152L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, M153-M153I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A243-A243 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, L244-L244 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, P337-P337H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, P337-P337L
|
4 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, P337-P337R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, P337-P337S
|
6 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E340-E340D
|
5 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E340-E340G
|
4 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E340-E340K
|
5 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E340-E340Q
|
7 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E340-E340V
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, R346-R346T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, K356-K356T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, T376-T376 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, F377-F377 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, K444-K444S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, V503-V503A
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Y505-Y505N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, R509-R509T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, K528-K528E
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, T547-T547K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A570-A570T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, T572-T572I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, D574-D574N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, L611-L611P
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, G639-G639V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, G669-G669 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, I670-I670N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, C671-C671 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A672-A672 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, S673-S673 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Y674-Y674 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Q675-Q675H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A694-A694S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, T859-T859 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, V860-V860 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A879-A879V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A893-A893S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, K921-K921 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, V951-V951L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, A956-A956E
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, V987-V987F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, R1019-R1019I Frameshift mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, Y1067-Y1067H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, F1089-F1089S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, F1095-F1095L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, E1150-E1150G
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, M1229-M1229I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, L1244-L1244 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, K1245-K1245 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 14, C1254-C1254 Stop codon mutation
|
7 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, F32-F32 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, R78-R78S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, F133-F133S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, D138-D138Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, P139-P139 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, L141-L141 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, G142-G142 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, V143-V143 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Y144-Y144 Deletion mutation
|
5 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Y145-Y145 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, H146-H146 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, N148-N148 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, I210-I210N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, N211-N211 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, P330-P330S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, P337-P337H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, P337-P337S
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, E340-E340A
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, E340-E340D
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, E340-E340G
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, E340-E340K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, E340-E340Q
|
4 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, E340-E340V
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, K356-K356R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, K356-K356T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, T376-T376 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, F377-F377 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, D420-D420N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, G446-G446D
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, G446-G446R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, G476-G476R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, N481-N481K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Y489-Y489H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, G496-G496V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Y505-Y505N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, L513-L513F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, L517-L517F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, T547-T547K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, T572-T572I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, S591-S591F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, G593-G593V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, P631-P631S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, I1227-I1227 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Q644-Q644 Frameshift mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, A647-A647S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Q675-Q675H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, T676-T676I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, K795-K795 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Q872-Q872 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, T883-T883I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, A899-A899C Frameshift mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, D979-D979V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, V987-V987F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, Q1002-Q1002 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, A1020-A1020V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, H1048-H1048Y
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, F1103-F1103V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, T1117-T1117I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >5%
Day 28, C1254-C1254 Stop codon mutation
|
5 Participants
|
SECONDARY outcome
Timeframe: At Day 7, Day 14 and Day 28Population: 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.
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.
Outcome measures
| Measure |
Sotrovimab 500 mg IV
n=156 Participants
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).
|
|---|---|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, G75-G75V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, P337-P337L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, P337-P337S
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, E340-E340A
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, E340-E340D
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, E340-E340G
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, E340-E340K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, E340-E340Q
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, S373-S373P
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, Q675-Q675H
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, L752-L752F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, A845-A845V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, A846-A846T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, Q913-Q913 Stop codon mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 7, P1053-P1053S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, L5-L5F
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, Y144-Y144 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, P337-P337L
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, P337-P337S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, E340-E340D
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, E340-E340K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, E340-E340Q
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, E340-E340V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, K356-K356T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, V503-V503A
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, Y505-Y505N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, A570-A570T
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, T572-T572I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, D574-D574N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, I670- I670N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, C671-C671 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, A672-A672 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, S673-S673 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, Y674-Y674 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, A956-A956E
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 14, L1244-L1244 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, Y144-Y144 Deletion mutation
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, I210-I210N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, N211-N211 Deletion mutation
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, P337-P337S
|
2 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, E340-E340A
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, E340-E340D
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, E340-E340G
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, E340-E340K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, E340-E340Q
|
3 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, E340-E340V
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, K356-K356R
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, D420-D420N
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, G446-G446D
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, N481-N481K
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, T572-T572I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, P631-P631S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, A647-A647S
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, T676-T676I
|
1 Participants
|
|
Number of Participants With Treatment-emergent Amino Acid Substitutions in the Spike Protein for Any Substitutions at Allelic Frequency >50%
Day 28, Q1002-Q1002 Stop codon mutation
|
1 Participants
|
Adverse Events
Sotrovimab 500 mg IV
Serious events: 0 serious events
Other events: 6 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Sotrovimab 500 mg IV
n=217 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
0.46%
1/217 • 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).
|
|
Investigations
Blood creatinine increased
|
0.46%
1/217 • 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).
|
|
Investigations
Neutrophil count increased
|
0.46%
1/217 • 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).
|
|
Investigations
White blood cell count increased
|
0.46%
1/217 • 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).
|
|
Nervous system disorders
Ageusia
|
0.46%
1/217 • 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).
|
|
Nervous system disorders
Anosmia
|
0.46%
1/217 • 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).
|
|
Nervous system disorders
Headache
|
0.46%
1/217 • 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).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.46%
1/217 • 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).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER