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Other Treatments Global Adoption
 
Sotrovimab COVID-19 studies. Efficacy is variant dependent. In Vitro studies suggest lower efficacy for omicron BA.1 [Liu, Sheward, VanBlargan] and no efficacy for omicron BA.2 [Zhou]. US EUA has been revoked. Monoclonal antibody use with variants can be associated with prolonged viral loads, clinical deterioration, and immune escape [Choudhary]. Recent:
Kneidinger
Cheng
Piccicacco
Aggarwal.
Sotrovimab has been officially adopted for early treatment in 10 countries. Submit updates/corrections.
Sep 20
Early, Late, PrEP, PEP Covid Analysis (Preprint) (meta analysis)
meta-analysis
Sotrovimab for COVID-19: real-time meta analysis of 9 studies
Details   • Statistically significant improvements are seen for mortality and hospitalization. 5 studies from 5 independent teams in 2 different countries show statistically significant improvements in isolation (2 for the most serious outcome). • ..
Sep 11
Early Cheng et al., medRxiv, doi:10.1101/2022.09.07.22279497 (Preprint)
death, ↓88.0%, p<0.0001
Real-world Effectiveness of Sotrovimab for the Early Treatment of COVID-19 During SARS-CoV-2 Delta and Omicron Waves in the United States
Details   Retrospective 1,530,501 high-risk patients in the USA, 15,633 treated with sotrovimab, showing significantly lower mortality and hospitalization with treatment. Sotrovimab maintained efficacy throughout the period analyzed - September 202..
Sep 9
Early Kneidinger et al., Infection, doi:10.1007/s15010-022-01914-8
severe case, ↑20.2%, p=0.79
Outcome of lung transplant recipients infected with SARS-CoV-2/Omicron/B.1.1.529: a Nationwide German study
Details   Retrospective 218 COVID+ lung transplant patients in Germany, showing no significant difference in severe cases with early sotrovimab use.
Aug 1
Early Piccicacco et al., Journal of Antimicrobial Chemotherapy, doi:10.1093/jac/dkac256
death, ↓66.4%, p=1.00
Real-world effectiveness of early remdesivir and sotrovimab in the highest-risk COVID-19 outpatients during the Omicron surge
Details   Retrospective high-risk outpatients in the USA, 82 treated with remdesivir, 88 with sotrovimab, and 90 control patients, showing significantly lower combined hospitalization/ER visits with both treatments in unadjusted results. The domina..
Jun 18
Early Aggarwal et al., medRxiv, doi:10.1101/2022.06.17.22276575 (Preprint)
death, ↓38.0%, p=0.62
Change in Effectiveness of Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients During the Omicron Phase
Details   Retrospective 30,247 outpatients in the USA, showing no significant differences with sotrovimab with omicron BA.1.
Apr 21
Early Zaqout et al., medRxiv, doi:10.1101/2022.04.21.22274060 (Preprint)
progression, ↑164.7%, p=0.19
Effectiveness of the neutralizing antibody sotrovimab among high-risk patients with mild to moderate SARS-CoV-2 in Qatar
Details   Retrospective 345 sotrovimab treated patients in Qatar matched with 583 patients that opted not to receive treatment, showing higher progression with treatment, without statistical significance.
Apr 5
News FDA (News)
news
FDA updates Sotrovimab emergency use authorization
Details   FDA has revoked sotrovimab's authorization in all regions due to predicted low efficacy with BA.2, and BA.2 exceeding 50% prevalence in all regions.
Apr 5
Early Aggarwal et al., medRxiv, doi:10.1101/2022.04.03.22273360 (Preprint)
death, ↓88.9%, p=0.048
Real-World Evidence of the Neutralizing Monoclonal Antibody Sotrovimab for Preventing Hospitalization and Mortality in COVID-19 Outpatients
Details   Retrospective 522 sotrovimab patients and matched controls in the USA, showing significantly lower hospitalization and mortality with treatment.
Mar 5
Early Ong et al., Antibiotics, doi:10.3390/antibiotics11030345
death, ↓60.5%, p=0.45
Real-World Use of Sotrovimab for Pre-Emptive Treatment in High-Risk Hospitalized COVID-19 Patients: An Observational Cross-Sectional Study
Details   Retrospective 19 sotrovimab patients and 75 controls is Singapore, showing lower progression with treatment.
Feb 16
In Vitro Zhou et al., bioRxiv, doi:10.1101/2022.02.15.480166 (Preprint) (In Vitro)
In Vitro
SARS-CoV-2 Omicron BA.2 Variant Evades Neutralization by Therapeutic Monoclonal Antibodies
Details   In Vitro study showing that omicron BA.2 evades all monoclonal antibodies tested, including sotrovimab and tixagevimab/cilgavimab which retained activity for omicron BA.1.
Dec 23
2021
Late Self et al., The Lancet Infectious Diseases, doi:10.1016/S1473-3099(21)00751-9
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
Details   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.
Dec 21
2021
Early Rockett et al., medRxiv, doi:10.1101/2021.12.18.21267628 (Preprint) Resistance conferring mutations in SARS-CoV-2 delta following sotrovimab infusion
Details   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 ..
Dec 20
2021
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)
Details   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.
Dec 17
2021
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
Details   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..
Dec 15
2021
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
Details   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.
Dec 4
2021
Early Gupta et al., JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21)
death, ↓80.0%, p=0.50
Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19
Details   RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization >24h or mortality with treatment.
May 26
2021
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
Details   Interim results from the COMET-ICE trial showing significantly lower hospitalization with treatment. NCT04545060.
Please send us corrections, updates, or comments. Vaccines and treatments are both valuable and complementary. All practical, effective, and safe means should be used. No treatment, vaccine, or intervention is 100% available and effective for all current and future variants. Denying the efficacy of any method increases mortality, morbidity, collateral damage, and the risk of endemic status. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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