Analgesics
Antiandrogens
Azvudine
Bromhexine
Budesonide
Colchicine
Conv. Plasma
Curcumin
Famotidine
Favipiravir
Fluvoxamine
Hydroxychlor..
Ivermectin
Lifestyle
Melatonin
Metformin
Minerals
Molnupiravir
Monoclonals
Naso/orophar..
Nigella Sativa
Nitazoxanide
Paxlovid
Quercetin
Remdesivir
Thermotherapy
Vitamins
More

Other
Feedback
Home
Top
Results
Abstract
All sotrovimab studies
Meta analysis
 
Feedback
Home
next
study
previous
study
c19early.org COVID-19 treatment researchSotrovimabSotrovimab (more..)
Melatonin Meta
Metformin Meta
Azvudine Meta
Bromhexine Meta Molnupiravir Meta
Budesonide Meta
Colchicine Meta
Conv. Plasma Meta Nigella Sativa Meta
Curcumin Meta Nitazoxanide Meta
Famotidine Meta Paxlovid Meta
Favipiravir Meta Quercetin Meta
Fluvoxamine Meta Remdesivir Meta
Hydroxychlor.. Meta Thermotherapy Meta
Ivermectin Meta

All Studies   Meta Analysis    Recent:   
0 0.5 1 1.5 2+ Mortality 80% Improvement Relative Risk Ventilation 89% Progression 75% Hospitalization >24hrs o.. 79% primary Sotrovimab  COMET-ICE  EARLY TREATMENT  DB RCT Is early treatment with sotrovimab beneficial for COVID-19? Double-blind RCT 1,057 patients in multiple countries (Aug 2020 - Sep 2021) Lower progression (p=0.00041) and death/hosp. (p=0.00039) c19early.org Gupta et al., JAMA, December 2021 Favors sotrovimab Favors control

Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19

Gupta et al., JAMA, doi:10.1001/jama.2022.2832 (results published 12/4/21), COMET-ICE, NCT04545060
Dec 2021  
  Post
  Facebook
Share
  Source   PDF   All   Meta
Sotrovimab for COVID-19
39th treatment shown to reduce risk in May 2023
 
*, now known with p = 0.0017 from 22 studies, recognized in 37 countries. Efficacy is variant dependent.
Lower risk for hospitalization.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
3,900+ studies for 60+ treatments. c19early.org
RCT 1,057 outpatients, 529 treated with sotrovimab, showing significantly lower hospitalization >24h or mortality with treatment.
Efficacy is variant dependent. In Vitro studies predict lower efficacy for BA.1 Liu, Sheward, VanBlargan, BA.4, BA.5 Haars, XBB.1.9.3, XBB.1.5.24, XBB.2.9, CH.1.1 Pochtovyi, and no efficacy for BA.2 Zhou, ХВВ.1.9.1, XBB.1.16, BQ.1.1.45, and CL.1 Pochtovyi. US EUA has been revoked.
risk of death, 80.0% lower, RR 0.20, p = 0.50, treatment 0 of 528 (0.0%), control 2 of 529 (0.4%), NNT 264, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 29.
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 (with reciprocal of the contrasting arm), day 29.
risk of progression, 75.0% lower, RR 0.25, p < 0.001, treatment 7 of 528 (1.3%), control 28 of 529 (5.3%), NNT 25, day 29.
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, primary outcome.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Conflicts of interest: research funding from the drug patent holder, employee of the drug patent holder.
Gupta et al., 4 Dec 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, 68 authors, study period 27 August, 2020 - 2 September, 2021, average treatment delay 2.6 days, trial NCT04545060 (history) (COMET-ICE).
This PaperSotrovimabAll
Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19
MD Anil Gupta, MD Yaneicy Gonzalez-Rojas, MD Erick Juarez, MD Manuel Crespo Casal, MD Jaynier Moya, MD Diego Rodrigues Falci, PhD Elias Sarkis, MD Joel Solis, MD Hanzhe Zheng, PhD Nicola Scott, MSc Andrea L Cathcart, PhD Sergio Parra, MD, MSc Jennifer E Sager, PhD Daren Austin, PhD Amanda Peppercorn, MD Elizabeth Alexander, MD, MSc Wendy W Yeh, MD Cynthia Brinson, MD Melissa Aldinger, PharmD Adrienne E Shapiro, Almena Free, Kimball Johnson, Edward Cordasco, Raymond Little, Ali Bajwa, Ankur Doshi, Augusto Focil, Rubaba (rubie) Hussain, Greg Bostick, Guillermo Somodevilla, Hasan Ali, John Kowalczyk, Shilpi Mittal, Jorge Caso, Marcy Goisse, Ladynez Espinal, Luis Zepeda, Thinh Nguyen, Luis Martinez, German Alvarez, Ronald Pucillo, Michael Seep, Naval Parikh, Victor Escobar, Armando Curra, Vinicius Dal Maso, John O'mahony, Eduardo Ramacciotti, Jorge Diaz, Kleber Luz, Peter Ruane, Bharat Mochlera, Juan Roldan Sanchez, Luis Hernandez, Alfredo Fernandez, Glenn Leavitt, Masoud Azizad, Haider Afzal, Adil Fatakia, Silvia Narejos Perez, Claudio Marcel Stadnik, Linda Gorgos, Yessica Sachdeva, Patricia Segura, Carlos Quandros, Russell Perry, Lawrence Sher
JAMA, doi:10.1001/jama.2022.2832
IMPORTANCE Older patients and those with comorbidities who are infected with SARS-CoV-2 may be at increased risk of hospitalization and death. Sotrovimab is a neutralizing antibody for the treatment of high-risk patients to prevent COVID-19 progression. OBJECTIVE To evaluate the efficacy and adverse events of sotrovimab in preventing progression of mild to moderate COVID-19 to severe disease.
Conclusions Among nonhospitalized patients with mild to moderate COVID-19 and at risk of disease progression, a single intravenous dose of sotrovimab, compared with placebo, signifi-cantly reduced the risk of a composite end point of all-cause hospitalization or death through day 29. The findings support sotrovimab as a treatment option for nonhospitalized, high-risk patients with mild to moderate COVID-19, although efficacy against SARS-CoV-2 variants that have emerged since the study was completed is unknown. Role of the Funder/Sponsor: The sponsors designed the trial and were involved in the conduct of the trial, data collection, management, analysis, and interpretation; participated in the preparation and review of the manuscript; but did not have the right to veto publication. The authors selected the journal and made the decision to submit the manuscript for publication. Group Information: A list of the COMET-ICE Investigators appears in Supplement 3. Data Sharing Statement: See Supplement 4. Additional Contributions: We thank Courtney St Amour, PhD (Cello Health Communications/ SciFluent), for medical writing support, which was funded by Vir Biotechnology Inc and GlaxoSmithKline. We also thank Krystyna Grycz, BA, Jordan Clark, BS, and Minnie Kuo, MS (all 3 employed by Vir Biotechnology Inc), for clinical operations support. These individuals were compensated as part of their normal salaries.
References
Cameroni, Bowen, Rosen, Broadly neutralizing antibodies overcome SARS-CoV-2 Omicron antigenic shift, Nature. Published online, doi:10.1038/s41586-021-04386-2
Cervantes, Martin, Frank, Experiences of Latinx individuals hospitalized for COVID-19: a qualitative study, JAMA Netw Open, doi:10.1001/jamanetworkopen.2021.0684?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jama.2022.2832
Chen, Nirula, Heller, None
Craft, Travassos, Palacios, Openshaw, Inadequate minority representation within SARS-CoV-2 vaccine trials, Am J Trop Med Hyg, doi:10.4269/ajtmh.20-1294
Fajnzylber, Regan, Coxen, Massachusetts Consortium for Pathogen Readiness. SARS-CoV-2 viral load is associated with increased disease severity and mortality, Nat Commun, doi:10.1038/s41467-020-19057-5
Flores, Frontera, Andrasik, Assessment of the inclusion of racial/ethnic minority, female, and older individuals in vaccine clinical trials, JAMA Netw Open, doi:10.1001/jamanetworkopen.2020.37640?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jama.2022.2832
Focosi, Maggi, Neutralising antibody escape of SARS-CoV-2 spike protein: risk assessment for antibody-based Covid-19 therapeutics and vaccines, Rev Med Virol, doi:10.1002/rmv.2231
Gao, Ding, Dong, Risk factors for severe and critically ill COVID-19 patients: a review, Allergy, doi:10.1111/all.14657
Gaudinski, Coates, Houser, Study Team. Safety and pharmacokinetics of the Fc-modified HIV-1 human monoclonal antibody VRC01LS: a phase 1 open-label clinical trial in healthy adults, PLoS Med, doi:10.1371/journal.pmed.1002493
Gupta, Gonzalez-Rojas, Juarez, Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab, N Engl J Med, doi:10.1056/NEJMoa2107934
Han, Poon, Powers, Iii, Leidy et al., Using the Influenza Patient-Reported Outcome (FLU-PRO) diary to evaluate symptoms of influenza viral infection in a healthy human challenge model, BMC Infect Dis, doi:10.1186/s12879-018-3220-8
Hwang, Shih, Cani, Arvin, Fink et al., Group sequential designs using a family of type I error probability spending functions, Stat Med, doi:10.1038/s41586-020-2538-8
Investigators, SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with Covid-19, N Engl J Med, doi:10.1056/NEJMoa2029849
Lan, Demets, Discrete sequential boundaries for clinical trials, Biometrika, doi:10.2307/2336502
Lempp, Soriaga, Montiel-Ruiz, Lectins enhance SARS-CoV-2 infection and influence neutralizing antibodies, Nature, doi:10.1038/s41586-021-03925-1
Levey, Bosch, Lewis, Greene, Rogers et al., Modification of Diet in Renal Disease Study Group. A more accurate method to estimate glomerular filtration rate from serum creatinine: Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19 Original Investigation Research jama.com, Ann Intern Med, doi:10.7326/0003-4819-130-6-199903160-00002
Liu, Wei, Zhang, V2 and 501Y.V3 variants of SARS-CoV-2 lose binding to bamlanivimab in vitro, MAbs, doi:10.1080/19420862.2021.1919285
Lustig, Zuckerman, Nemet, Neutralising capacity against Delta (B.1.617.2) and other variants of concern following Comirnaty (BNT162b2, BioNTech/Pfizer) vaccination in health care workers, Israel, Euro Surveill, doi:10.2807/1560-7917.ES.2021.26.26.2100557
Pinto, Park, Beltramello, Cross-neutralization of SARS-CoV-2 by a human monoclonal SARS-CoV antibody, Nature, doi:10.1038/s41586-020-2349-y
Riley, Chen, Matthay, Excess mortality among Latino people in California during the COVID-19 pandemic, SSM Popul Health, doi:10.1016/j.ssmph.2021.100860
Seyedalinaghi, Afsahi, Mohssenipour, Late complications of COVID-19; a systematic review of current evidence, Arch Acad Emerg Med
Starr, Greaney, Dingens, Bloom, Complete map of SARS-CoV-2 RBD mutations that escape the monoclonal antibody LY-CoV555 and its cocktail with LY-CoV016, Cell Rep Med, doi:10.1016/j.xcrm.2021.100255
Stokes, Zambrano, Anderson, Coronavirus disease 2019 case surveillance-United States, MMWR Morb Mortal Wkly Rep, doi:10.15585/mmwr.mm6924e2
Vanblargan, Errico, Halfmann, An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by therapeutic monoclonal antibodies, Nat Med. Published online, doi:10.1038/s41591-021-01678-y
Wiersinga, Rhodes, Cheng, Peacock, Prescott, Pathophysiology, transmission, diagnosis, and treatment of coronavirus disease 2019 (COVID-19): a review, JAMA, doi:10.1001/jama.2020.12839?utm_campaign=articlePDF%26utm_medium=articlePDFlink%26utm_source=articlePDF%26utm_content=jama.2022.2832
Zheng, Yu, Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study, BMJ, doi:10.1136/bmj.m1443
Loading..
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. 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.
  or use drag and drop   
Submit