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Late |
Self et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(21)00751-9 (Peer Reviewed) |
death, ↑2.0%, p=0.96 |
Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial |
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RCT with 182 sotrovimab patients and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility. TICO. NCT04501978. |
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Late treatment study
Late treatment study
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| Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trial |
| Self et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(21)00751-9 (Peer Reviewed) |
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RCT with 182 sotrovimab patients and 178 control patients, median 8 days from symptom onset, showing no significant differences and terminated early due to futility. TICO. NCT04501978.
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risk of death, 2.0% higher, RR 1.02, p = 0.96, treatment 14 of 182 (7.7%), control 13 of 178 (7.3%), day 90.
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risk of no recovery, 10.7% lower, RR 0.89, p = 0.29, treatment 22 of 160 (13.8%), control 27 of 178 (15.2%), NNT 70, day 90.
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risk of no recovery, 7.4% lower, RR 0.93, p = 0.69, treatment 160, control 178, pulmonary-plus ordinal outcome @day 5.
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Self et al., 12/23/2021, Double Blind Randomized Controlled Trial, multiple countries, multiple regions, peer-reviewed, 647 authors, 16 December, 2020 - 1 March, 2021.
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Early |
Rockett et al., medRxiv, doi:10.1101/2021.12.18.21267628 (Preprint) |
Resistance conferring mutations in SARS-CoV-2 delta following sotrovimab infusion |
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Retrospective 100 sotrovimab patients in Australia, 23 PCR+ more than 10 days post-infusion (68 with status unknown), showing rapid development of spike gene mutations that have been shown to confer high level resistance to sotrovimab in .. |
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Early treatment study
Early treatment study
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| Resistance conferring mutations in SARS-CoV-2 delta following sotrovimab infusion |
| Rockett et al., medRxiv, doi:10.1101/2021.12.18.21267628 (Preprint) |
Retrospective 100 sotrovimab patients in Australia, 23 PCR+ more than 10 days post-infusion (68 with status unknown), showing rapid development of spike gene mutations that have been shown to confer high level resistance to sotrovimab in vitro.
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Rockett et al., 12/21/2021, preprint, 26 authors.
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In Vitro |
Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 (Preprint) (In Vitro) |
in vitro |
Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron) |
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In Vitro study showing that omicron is substantially resistant to neutralization by monoclonal antibodies REGN10933, REGN10987, Ly-CoV016 and Ly-CoV555. S309 (the parent of Sotrovimab) had only 2-fold loss in potency. |
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In Vitro
In Vitro
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| Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron) |
| Sheward et al., bioRxiv, doi:10.1101/2021.12.19.473354 (Preprint) (In Vitro) |
In Vitro study showing that omicron is substantially resistant to neutralization by monoclonal antibodies REGN10933, REGN10987, Ly-CoV016 and Ly-CoV555. S309 (the parent of Sotrovimab) had only 2-fold loss in potency.
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Sheward et al., 12/20/2021, preprint, 11 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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In Vitro |
VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 (Preprint) (In Vitro) |
in vitro |
An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies |
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In vitro study (Vero-TMPRSS2 and Vero-hACE2-TMPRSS2) showing complete loss of inhibitory activity for B.1.1.529 omicron with LY-CoV555, LY-CoV016, REGN10933, REGN10987, and CT-P59, ~12-fold decrease for COV2-2196/COV2-2130, and minimal ch.. |
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In Vitro
In Vitro
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| An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies |
| VanBlargan et al., bioRxiv, doi:10.1101/2021.12.15.472828 (Preprint) (In Vitro) |
In vitro study (Vero-TMPRSS2 and Vero-hACE2-TMPRSS2) showing complete loss of inhibitory activity for B.1.1.529 omicron with LY-CoV555, LY-CoV016, REGN10933, REGN10987, and CT-P59, ~12-fold decrease for COV2-2196/COV2-2130, and minimal change for S309.
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VanBlargan et al., 12/17/2021, preprint, 10 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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In Vitro |
Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 (Preprint) (In Vitro) |
in vitro |
Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2 |
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In vitro study (Vero-E6-TMPRSS2) showing 18 of 19 monoclonal antibodies were no longer effective or significantly impaired with B.1.1.529 omicron. |
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In Vitro
In Vitro
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| Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2 |
| Liu et al., bioRxiv, doi:10.1101/2021.12.14.472719 (Preprint) (In Vitro) |
In vitro study (Vero-E6-TMPRSS2) showing 18 of 19 monoclonal antibodies were no longer effective or significantly impaired with B.1.1.529 omicron.
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Liu et al., 12/15/2021, preprint, 23 authors.
In Vitro studies are an important part of preclinical research, however results may be very different in vivo.
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Early |
Gupta et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.701 (Peer Reviewed) |
death, ↓88.9%, p=0.12 |
Early COVID-19 Treatment with SARS-CoV-2 Neutralizing Antibody Sotrovimab |
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RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization and ICU admission with treatment. NCT04545060.
The preprint [1] for this study appears to show different results: 10, 6, 2 for ICU, ventilati.. |
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Early treatment study
Early treatment study
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| Early COVID-19 Treatment with SARS-CoV-2 Neutralizing Antibody Sotrovimab |
| Gupta et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.701 (Peer Reviewed) |
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RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization and ICU admission with treatment. NCT04545060.The preprint [1] for this study appears to show different results: 10, 6, 2 for ICU, ventilation, death, compared to 9, 4, 4 in this paper.
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risk of death, 88.9% lower, RR 0.11, p = 0.12, treatment 0 of 528 (0.0%), control 4 of 529 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events.
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risk of mechanical ventilation, 88.9% lower, RR 0.11, p = 0.12, treatment 0 of 528 (0.0%), control 4 of 529 (0.8%), NNT 132, relative risk is not 0 because of continuity correction due to zero events.
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risk of ICU admission, 94.7% lower, RR 0.05, p = 0.004, treatment 0 of 528 (0.0%), control 9 of 529 (1.7%), NNT 59, relative risk is not 0 because of continuity correction due to zero events.
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risk of hospitalization >24hrs or death, 79.0% lower, RR 0.21, p < 0.001, treatment 6 of 528 (1.1%), control 30 of 529 (5.7%), NNT 22, day 29, ITT.
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Conflicts of interest:
research funding from the drug patent holder, employee of the drug patent holder.
Gupta et al., 12/4/2021, Double Blind Randomized Controlled Trial, multiple countries, multiple regions, peer-reviewed, 22 authors.
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Early |
Gupta et al., NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021) (Preprint) |
death, ↓66.6%, p=1.00 |
Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab |
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Interim results from the COMET-ICE trial showing significantly lower hospitalization with treatment. NCT04545060. |
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Early treatment study
Early treatment study
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| Early Treatment for Covid-19 with SARS-CoV-2 Neutralizing Antibody Sotrovimab |
| Gupta et al., NEJM, doi:10.1056/NEJMoa2107934 (news release 5/26/2021) (Preprint) |
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Interim results from the COMET-ICE trial showing significantly lower hospitalization with treatment. NCT04545060.
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risk of death, 66.6% lower, RR 0.33, p = 1.00, treatment 0 of 291 (0.0%), control 1 of 292 (0.3%), NNT 292, relative risk is not 0 because of continuity correction due to zero events.
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risk of mechanical ventilation, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 291 (0.0%), control 2 of 292 (0.7%), NNT 146, relative risk is not 0 because of continuity correction due to zero events.
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risk of ICU admission, 90.9% lower, RR 0.09, p = 0.06, treatment 0 of 291 (0.0%), control 5 of 292 (1.7%), NNT 58, relative risk is not 0 because of continuity correction due to zero events.
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risk of hospitalization, 80.9% lower, RR 0.19, p < 0.001, treatment 4 of 291 (1.4%), control 21 of 292 (7.2%), NNT 17.
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risk of hospitalization, 85.7% lower, RR 0.14, p < 0.001, treatment 3 of 291 (1.0%), control 21 of 292 (7.2%), NNT 16, >24hrs.
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Gupta et al., 5/26/2021, Double Blind Randomized Controlled Trial, USA, North America, preprint, 22 authors.
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