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COVID-19 Monoclonal Antibody Use at a Stand Alone Children’s Hospital

Stimes et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofad500.615

Nov 2023

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Casirivimab/imdevimab

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.

Lower risk for hospitalization, progression, recovery, cases, and viral clearance.

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. c19early.org

Retrospective 262 pediatric patients referred for COVID-19 monoclonal antibody treatment, 134 treated (74% receiving casirivimab/imdevimab), showing higher ER visits and hospitalization with treatment, without statistical significance. Authors do not provide results for specific treatments.

Efficacy is variant dependent. In Vitro research suggests a lack of efficacy for many omicron variants Haars, Liu, Pochtovyi, Sheward, Tatham, VanBlargan.

1. Haars et al., Prevalence of SARS-CoV-2 Omicron Sublineages and Spike Protein Mutations Conferring Resistance against Monoclonal Antibodies in a Swedish Cohort during 2022–2023, Microorganisms, doi:10.3390/microorganisms11102417.mdpi.com, doi.org.

2. Liu et al., Striking Antibody Evasion Manifested by the Omicron Variant of SARS-CoV-2, bioRxiv, doi:10.1101/2021.12.14.472719.biorxiv.org, doi.org.

3. Pochtovyi et al., In Vitro Efficacy of Antivirals and Monoclonal Antibodies against SARS-CoV-2 Omicron Lineages XBB.1.9.1, XBB.1.9.3, XBB.1.5, XBB.1.16, XBB.2.4, BQ.1.1.45, CH.1.1, and CL.1, Vaccines, doi:10.3390/vaccines11101533.mdpi.com, doi.org.

4. Sheward et al., Variable loss of antibody potency against SARS-CoV-2 B.1.1.529 (Omicron), bioRxiv, doi:10.1101/2021.12.19.473354.biorxiv.org, doi.org.

5. Tatham et al., Lack of Ronapreve (REGN-CoV; casirivimab and imdevimab) virological efficacy against the SARS-CoV 2 Omicron variant (B.1.1.529) in K18-hACE2 mice, bioRxiv, doi:10.1101/2022.01.23.477397.biorxiv.org, doi.org.

6. VanBlargan et al., An infectious SARS-CoV-2 B.1.1.529 Omicron virus escapes neutralization by several therapeutic monoclonal antibodies, bioRxiv, doi:10.1101/2021.12.15.472828.biorxiv.org, doi.org.

Important missing comments or errors? Let us know.

risk of hospitalization, 91.0% higher, RR 1.91, p = 0.50, treatment 6 of 134 (4.5%), control 3 of 128 (2.3%).

ER visit, 91.0% higher, RR 1.91, p = 0.38, treatment 8 of 134 (6.0%), control 4 of 128 (3.1%).

Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates

Stimes et al., 27 Nov 2023, USA, peer-reviewed, 6 authors, study period 1 December, 2020 - 5 May, 2022.

This Paper Casirivimab/i..All

PharmD, MPA, BCIDP Grant T Stimes, PharmD, BCIDP Brittany Rodriguez, PharmD Amanda Gillispie, MSN, MHA, RN, CPHON Tanya J Hilliard, MD, MSc Flor M Munoz, MD Lisa Forbes Satter

50 vs WA1). Evaluation of CH.1.1 and XBF by introducing variant-defining mutations into the replicon showed no change in in vitro susceptibility (< 1.8-fold change). Phenotyping of clinical isolates of BF.7, BQ.1, XBB.1.5, and CH.1.1 indicated no loss of RDV or ODV in vitro antiviral activity (< 1.3-fold change).

{ 'DOI': '10.1093/ofid/ofad500.615', 'ISSN': ['2328-8957'], 'URL': 'http://dx.doi.org/10.1093/ofid/ofad500.615', 'abstract': 'Abstract\n' ' \n' ' Background\n' ' Texas Children’s Hospital (TCH) implemented an outpatient clinic ' 'for eligible patients to receive infusions when COVID monoclonal antibodies (mAbs) were ' 'approved for use in non-hospitalized, high-risk patients with mild to moderate COVID-19. ' 'There are limited data evaluating the use of outpatient COVID mAbs in pediatric patients. We ' 'describe the clinical characteristics and outcomes of the patients treated with COVID mAbs at ' 'TCH.\n' ' \n' ' \n' ' Methods\n' ' Patients that were referred to receive COVID mAbs from 12/1/2020 to ' '5/5/2022 were included. Information collected included demographics, comorbidities, refusal ' 'reason, adverse events, emergency center (EC) visits or admission within 14 days after final ' 'dose, and EC visit or admission within 14 days of referral if patients did not receive COVID ' 'mAbs. Chi-square was used to determine differences between the groups.\n' ' \n' ' \n' ' Results\n' ' There were 262 patients referred during the study period. The ' 'median age of all referred patients was 15.8 years (IQR 14-17.4 years). Majority of referrals ' 'were for treatment of COVID-19 infection rather than post-exposure prophylaxis (92.8% vs ' '7.2%). Of the 262 referrals, 134 patients received COVID mAbs (51.2%) while 128 patients were ' 'not treated. Majority of the patients received casirivimab-imdevimab (73.9%). The ' 'comorbidities of all patients are shown in Figure 1. The most common reasons for patients to ' 'not receive COVID mAbs were no drug available or not listed, and the full list of reasons are ' 'listed in Figure 2. The median time from reported symptom onset to infusion was 4 days (IQR ' '2-6 days). Of the 134 infused patients, 8 patients (6%) visited the EC within 14 days from ' 'infusion, and 6 (4.5%) were admitted while 4 patients (3.1%) that did not receive an antibody ' 'visited the EC resulting in 3 admissions (2.3%) (EC visits p=0.27; admissions p=0.34). There ' 'were 11 patients (8.2%) that experienced adverse events from their infusion, which led to 5 ' 'of the 8 EC visits. Comorbidities were similar across the infused and non-infused groups ' '(p=0.16).\n' ' \n' ' Number of high-risk conditions represented by all referred, ' 'high-risk patients\n' ' \n' ' Number of patients for each reason for not receiving a COVID-19 ' 'antibody infusion\n' ' \n' ' \n' ' Conclusion\n' ' COVID mAb treatments were well tolerated among pediatric patients. ' 'Majority of patients in both groups did not require EC visit or hospitalization. More data ' 'are needed to determine the clinical efficacy of mAbs patients.\n' ' \n' ' \n' ' Disclosures\n' ' Flor M. Munoz, MD, MSc, CDC respiratory virus surveillance: ' 'Grant/Research Support|Gilead: Grant/Research Support|Moderna, sanofi, aztra zeneca, Merck, ' 'GSK: Advisor/Consultant|NIH: DSMB|NIH COVID-19 vaccines in pregnancy: Grant/Research ' 'Support|Pfizer Pediatric COVID-19 vaccines: Grant/Research Support|Pfizer, Dynavax, Monderna, ' 'Meissa, NIH: DSMB Lisa Forbes Satter, MD, ADMA: Advisor/Consultant|CsL Behring: ' 'Advisor/Consultant|Grifols: Advisor/Consultant|incyte: Advisor/Consultant|Pharming: ' 'Advisor/Consultant|Takeda: Advisor/Consultant\n' ' ', 'author': [ { 'affiliation': [{'name': "Texas Children's Hospital , Houston, Texas"}], 'family': 'Stimes', 'given': 'Grant T', 'sequence': 'first'}, { 'affiliation': [{'name': "Texas Children's Hospital , Houston, Texas"}], 'family': 'Rodriguez', 'given': 'Brittany', 'sequence': 'additional'}, { 'affiliation': [{'name': "Texas Children's Hospital , Houston, Texas"}], 'family': 'Gillispie', 'given': 'Amanda', 'sequence': 'additional'}, { 'affiliation': [{'name': "Texas Children's Hospital , Houston, Texas"}], 'family': 'Hilliard', 'given': 'Tanya J', 'sequence': 'additional'}, { 'affiliation': [{'name': 'Baylor College of Medicine , Houston, TX'}], 'family': 'Munoz', 'given': 'Flor M', 'sequence': 'additional'}, { 'affiliation': [{'name': 'Baylor College of Medicine , Houston, TX'}], 'family': 'Satter', 'given': 'Lisa Forbes', 'sequence': 'additional'}], 'container-title': 'Open Forum Infectious Diseases', 'content-domain': {'crossmark-restriction': False, 'domain': []}, 'created': { 'date-parts': [[2023, 11, 27]], 'date-time': '2023-11-27T02:13:24Z', 'timestamp': 1701051204000}, 'deposited': { 'date-parts': [[2023, 11, 27]], 'date-time': '2023-11-27T02:13:25Z', 'timestamp': 1701051205000}, 'indexed': { 'date-parts': [[2023, 11, 27]], 'date-time': '2023-11-27T05:18:16Z', 'timestamp': 1701062296969}, 'is-referenced-by-count': 0, 'issue': 'Supplement_2', 'issued': {'date-parts': [[2023, 11, 27]]}, 'journal-issue': {'issue': 'Supplement_2', 'published-print': {'date-parts': [[2023, 11, 27]]}}, 'language': 'en', 'license': [ { 'URL': 'https://creativecommons.org/licenses/by/4.0/', 'content-version': 'vor', 'delay-in-days': 0, 'start': { 'date-parts': [[2023, 11, 27]], 'date-time': '2023-11-27T00:00:00Z', 'timestamp': 1701043200000}}], 'link': [ { 'URL': 'https://academic.oup.com/ofid/article-pdf/10/Supplement_2/ofad500.615/53772285/ofad500.615.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/ofid/article-pdf/10/Supplement_2/ofad500.615/53772285/ofad500.615.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'member': '286', 'original-title': [], 'prefix': '10.1093', 'published': {'date-parts': [[2023, 11, 27]]}, 'published-online': {'date-parts': [[2023, 11, 27]]}, 'published-other': {'date-parts': [[2023, 12]]}, 'published-print': {'date-parts': [[2023, 11, 27]]}, 'publisher': 'Oxford University Press (OUP)', 'reference-count': 0, 'references-count': 0, 'relation': {}, 'resource': { 'primary': { 'URL': 'https://academic.oup.com/ofid/article/doi/10.1093/ofid/ofad500.615/7448106'}}, 'score': 1, 'short-title': [], 'source': 'Crossref', 'subject': ['Infectious Diseases', 'Oncology'], 'subtitle': [], 'title': '546. COVID-19 Monoclonal Antibody Use at a Stand Alone Children’s Hospital', 'type': 'journal-article', 'volume': '10'}

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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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