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0 0.5 1 1.5 2+ ICU admission 89% Improvement Relative Risk Oxygen therapy 85% Hospitalization 75% Casirivimab/i..  Bierle et al.  EARLY TREATMENT Is early treatment with casirivimab/imdevimab beneficial for COVID-19? Retrospective 1,395 patients in the USA Lower need for oxygen therapy (p<0.0001) and lower hospitalization (p<0.0001) Bierle et al., The J. Infectious Disea.., Oct 2021 Favors casirivimab/im.. Favors control

Monoclonal Antibody Treatment of Breakthrough COVID-19 in Fully Vaccinated Individuals with High-Risk Comorbidities

Bierle et al., The Journal of Infectious Diseases, doi:10.1093/infdis/jiab570 (date from preprint)
Oct 2021  
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16th treatment shown to reduce risk in March 2021
*, now known with p = 0.000018 from 28 studies, recognized in 42 countries. Efficacy is variant dependent.
No treatment is 100% effective. Protocols combine complementary and synergistic treatments. * >10% efficacy in meta analysis with ≥3 clinical studies.
4,100+ studies for 60+ treatments.
Retrospective 1,395 vaccinated COVID-19 cases, showing significantly lower hospitalization and oxygen supplementation with monoclonal antibody treatment, primarily casirivimab-imdevimab. Hospitalization was significantly associated with comorbidities.
Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants Haars, Liu, Pochtovyi, Sheward, Tatham, VanBlargan.
This study is excluded in meta analysis: patients were treated with different medications, results specific to each medication were not reported.
risk of ICU admission, 88.9% lower, RR 0.11, p = 0.16, treatment 0 of 527 (0.0%), control 5 of 868 (0.6%), NNT 174, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
risk of oxygen therapy, 85.3% lower, RR 0.15, p < 0.001, treatment 5 of 527 (0.9%), control 56 of 868 (6.5%), NNT 18, odds ratio converted to relative risk.
risk of hospitalization, 75.3% lower, RR 0.25, p < 0.001, treatment 14 of 527 (2.7%), control 93 of 868 (10.7%), NNT 12, odds ratio converted to relative risk.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Conflicts of interest: research funding from the drug patent holder.
Bierle et al., 20 Oct 2021, retrospective, USA, peer-reviewed, 7 authors, average treatment delay 5.0 days. Contact:
This PaperCasirivimab/i..All
Dennis M Bierle, Ravindra Ganesh, Sidna Tulledge-Scheitel, Sara N Hanson, Lori L Arndt, Caroline G Wilker, MD Raymund R Razonable
Breakthrough COVID-19 may occur among vaccinated individuals with a high number of medical comorbidities, especially during the SARS-CoV-2 Delta surge. Anti-spike monoclonal antibody treatment was associated with significantly lower rates of hospitalization, particularly among highrisk persons.
Conflict of Interest Statement: Dr. Razonable is principal investigator of research funded by Regeneron, Roche, Gilead (all funds provided to his institution), and is a member of Data Safety Monitoring Board of Novartis, on projects not directly related to this submission. Dr. Razonable received research funds from the Mayo Clinic for studies on monoclonal antibodies for COVID-19. All other no conflict to report. Results The total population consisted of 1395 fully vaccinated patients (mean age, 54.3 years; 39.6% male) with breakthrough COVID-19 and were screened for monoclonal antibody therapy, under US FDA EUA guidance. The majority of breakthrough SARS-CoV-2 infections (n=1002; 71.8%) occurred during a 6-week period from July 1 to August 16, 2021, when the Delta variant was predominant in our region (Supplemental Figure). The most common medical comorbidities were hypertension (34.5%), cardiovascular disease (13.8%), chronic pulmonary disease (13.6%), and chronic kidney disease (10.2%) (Table 1 ). A total of 170 (12.2%) patients were immunocompromised, including 149 patients (10.7%) with solid cancer and hematologic malignancies and 35 (2.5%) transplant recipients. Most patients (69.8%) received the Pfizer-BioNTech SARS-CoV-2 mRNA vaccine. Breakthrough COVID-19 occurred at median of 124 days (mean, 120 days) after full completion of the vaccination series. At 28 days after breakthrough COVID-19 diagnosis, 107 patients (7.7%) had progressed to require hospitalization...
Baden, Sahly, Essink, Efficacy and Safety of the mRNA-1273 SARS-CoV-2
Bergwerk, Gonen, Lustig, Covid-19 Breakthrough Infections in Vaccinated Health Care Workers, N Engl J Med
Bernal, Andrews, Gower, Effectiveness of Covid-19 Vaccines against the B.1.617.2 (Delta) Variant, N Engl J Med
Bierle, Ganesh, Wilker, Influence of Social and Cultural Factors on the Decision to Consent for Monoclonal Antibody Treatment among High-Risk Patients with Mild-Moderate COVID-19, J Prim Care Community Health
Ganesh, Pawlowski, Horo, Intravenous bamlanivimab use associates with reduced hospitalization in high-risk patients with mild to moderate COVID-19, J Clin Invest
Ganesh, Philpot, Bierle, Real-World Clinical Outcomes of Bamlanivimab and Casirivimab-Imdevimab among High-Risk Patients with Mild to Moderate Coronavirus Disease 2019, J Infect Dis
Razonable, Aloia, Anderson, A Framework for Outpatient Infusion of Antispike Monoclonal Antibodies to High-Risk Patients with Mild-to-Moderate Coronavirus Disease-19: The Mayo Clinic Model, Mayo Clin Proc
Razonable, Pawlowski, Horo, Bierle, Arndt et al., Casirivimab-Imdevimab Treatment is Associated with Reduced Rates of Hospitalization among High-Risk Patients with Mild to Moderate Coronavirus Disease-19, EClinicalMedicine
Swift, Breeher, Tande, Effectiveness of Messenger RNA Coronavirus Disease
Von Elm, Altman, Egger, The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies, Lancet
Weinreich, Sivapalasingam, Norton, COV2, a Neutralizing Antibody Cocktail, in Outpatients with Covid-19, N Engl J Med
Wilhelm, Toptan, Pallas, Antibody-Mediated Neutralization of Authentic SARS-CoV-2 B.1.617 Variants Harboring L452R and T478K/E484Q, Viruses
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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.
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