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Safety and Efficacy of Combination SARS-CoV-2 Monoclonal Neutralizing Antibodies (mAb) BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients

Evering et al., Open Forum Infectious Diseases, doi:10.1093/ofid/ofab466.1643, NCT03383419
Nov 2021  
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Mortality 89% Improvement Relative Risk Hospitalization 73% Death/hospitalization 79% Ambavirumab/r..  Evering et al.  EARLY TREATMENT  DB RCT Is early treatment with ambavirumab beneficial for COVID-19? Double-blind RCT 837 patients in multiple countries (Jan - Jul 2021) Lower mortality (p=0.021) and hospitalization (p<0.0001) Evering et al., Open Forum Infectious .., Nov 2021 Favorsambavirumab Favorscontrol 0 0.5 1 1.5 2+
RCT 837 non-hospitalized high-risk COVID-19 patients showing 78% reduction in hospitalization and death with BRII-196/BRII-198 (monoclonal antibodies). Study was terminated early. BRII-196/BRII-198 had fewer grade 3+ adverse events (3.8% vs 13.4%).
Efficacy is variant dependent.
risk of death, 88.9% lower, RR 0.11, p = 0.02, treatment 1 of 418 (0.2%), control 9 of 419 (2.1%), NNT 52.
risk of hospitalization, 73.3% lower, RR 0.27, p < 0.001, treatment 12 of 418 (2.9%), control 45 of 419 (10.7%), NNT 13.
risk of death/hospitalization, 78.7% lower, RR 0.21, p < 0.001, treatment 10 of 418 (2.4%), control 47 of 419 (11.2%), NNT 11.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Evering et al., 1 Nov 2021, Double Blind Randomized Controlled Trial, placebo-controlled, multiple countries, peer-reviewed, median age 49.0, 18 authors, study period January 2021 - July 2021, trial NCT03383419 (history).
This PaperAmbavir../r..All
LB2. Safety and Efficacy of Combination SARS-CoV-2 Monoclonal Neutralizing Antibodies (mAb) BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients
MD Pablo Ryan, PhD Gregory Camus, Gilead, PhD Danielle P Porter, DPhil Robert H Hyland, PhD Shuguang Chen, MD Kavita Juneja, MD Frank Duff, MD Robert L Gottlieb, Eli Lilly, MD Teresa H Evering, Ph.D Mark Giganti, MD Kara W Chew, Ph.D Michael Hughes, Ph.D Carlee Moser, MD David Alain Wohl, M.D Judith Currier, MD Joseph J Eron, M.D Arzhang Javan, M.P.H D T M&h, MD MPH David A Margolis, PhD Qing Zhu, MD Ulises D' Andrea, M.D. 10 Keila Hoover, M.D Bharat R Mocherla, Pharm.D. 12 Courtney Fletcher, M.D Jonathan Li, M.D. 14 Davey Smith, Eric Daar
S807 treatment of patients hospitalized with moderate to severe COVID-19. This Phase 3 (GS-US-540-9012) double-blind, placebo-controlled study compared the efficacy and safety of 3 days of RDV to standard of care in non-hospitalized, high-risk participants with confirmed COVID-19. Table 1. COVID-19 related hospitalization or death, COVID-19 related medically attended visits or death, and Treatment Emergent Adverse Events Methods. Participants were randomly assigned 1:1 to receive intravenous (IV) RDV (200 mg on day 1, 100 mg on days 2 to 3) or placebo. The primary efficacy endpoint was composite COVID-19 hospitalization or all-cause death by day 28 and compared using Cox proportional hazards model with baseline stratification factors as covariates. The primary safety endpoint was proportion of participants with treatment-emergent adverse events. Study enrollment was terminated early for administrative reasons in light of the evolving pandemic. Results. 562 patients underwent randomization and started their assigned treatment (279, RDV; 283, placebo). Baseline demographics and characteristics were balanced across arms. Overall, 52% were male, 44% were Hispanic/Latino ethnicity and 30% were ≥ 60 years old. The most common comorbidities were diabetes mellitus (62%), obesity (56%; median BMI, 30.7), and hypertension (48%). Median baseline SARS-CoV-2 RNA nasopharyngeal viral load was 6.2 log 10 copies/mL. Treatment with RDV significantly reduced COVID-19 hospitalization or all-cause death by day 28 (HR, 0.13; 95% CI, 0.03 -0.59; p = 0.008; Table 1 ) compared to placebo. Participants receiving RDV also had significantly lower risk for COVID-19-related medically attended visits or all-cause death by day 28 compared to placebo (HR, 0.19; 95% CI, 0.07 -0.56; p = 0.002; Table 1 ). No deaths occurred in either arm by day 28. There was no difference between arms in time-weighted average change in nasopharyngeal viral loads from baseline up to day 7. The proportion of patients with AEs was similar between arms (Table 1 ); the most common AEs in the RDV arm were nausea (11%), headache (6%), and diarrhea (4%). Conclusion. A 3-day course of IV RDV was safe, well tolerated and highly effective at preventing COVID-19 related hospitalization or death in high-risk non-hospitalized COVID-19 patients. Disclosures.
Methods. COV-BARRIER (NCT04421027) was a randomized double-blind, placebo-controlled trial in patients with confirmed SARS-CoV-2 infection and elevation of ≥ 1 serum inflammatory marker. In this newly completed substudy, enrolled participants (not previously reported) from 4 countries on IMV or ECMO at study entry were randomly assigned 1:1 to once-daily BARI 4-mg or placebo (PBO) for up to 14 days plus standard of care (SOC), which included baseline systemic corticosteroid use in 86% of patients. The prespecified exploratory endpoints included all-cause mortality and number of ventilator-free days (VFDs) through Day 28. Results. Characteristics for 101 participants are shown in Table 1 . Treatment with BARI significantly reduced all-cause mortality by Day 28 compared to PBO [39.2% vs 58.0%, respectively; hazard ratio (HR) = 0.54 (95%CI 0.31, 0.96), p=0.030, relative risk (RR) = 0.68 (95%CI 0.45, 1.02); Figure 1A ]. One additional death was prevented for every six BARI-treated patients. Significant reduction in mortality was also observed by Day 60 [45.1% vs 62.0%; HR = 0.56 (95%CI 0.33, 0.97), p=0.027, RR = 0.73 (95%CI 0.50, 1.06); Figure 1B ]. Patients treated with BARI showed a numerical reduction in the duration of IMV and duration of hospitalization vs PBO and more BARI treated patients recovered (Table 2 ). No new safety findings were observed (Table 2 ). Conclusion. Treatment with BARI+SOC (corticosteroids) resulted in an absolute risk reduction in mortality of..
{ 'indexed': {'date-parts': [[2024, 4, 29]], 'date-time': '2024-04-29T02:18:06Z', 'timestamp': 1714357086503}, 'reference-count': 0, 'publisher': 'Oxford University Press (OUP)', 'issue': 'Supplement_1', 'license': [ { 'start': { 'date-parts': [[2021, 12, 4]], 'date-time': '2021-12-04T00:00:00Z', 'timestamp': 1638576000000}, 'content-version': 'vor', 'delay-in-days': 33, 'URL': ''}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2021, 12, 4]]}, 'abstract': '<jats:title>Abstract</jats:title>\n' ' <jats:sec>\n' ' <jats:title>Background</jats:title>\n' ' <jats:p>SARS-CoV-2 continues to spread and the development of safe and ' 'effective therapeutics for the prevention of severe disease remains a priority. BRII-196 and ' 'BRII-198 are non-competing anti-SARS-CoV-2 mAbs with YTE triple amino acid substitution in Fc ' 'to extend half-life and reduce receptor binding, that are being studied for treatment of ' 'COVID-19 in the ACTIV-2 Trial, sponsored by NIAID and led by ACTG.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>ACTIV-2 evaluates safety/efficacy of investigational agents for ' 'treatment of non-hospitalized adults with mild-moderate COVID-19 under a randomized, blinded, ' 'controlled adaptive platform. BRII-196/BRII-198 (1000 mg each) as a single dose given as ' 'sequential infusions, or placebo to those at high risk of clinical progression (i.e., age ≥ ' '60 years or presence of other medical conditions) within 10 days of symptom onset and ' 'positive test for SARS-CoV-2. The primary endpoint was hospitalization and/or death through ' 'day 28. We report Phase 3 BRII-196/BRII-198 trial results per DSMB recommendation following ' 'an interim analysis.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Between January and July 2021, 837 participants (418 active, 419 ' 'placebo) from sites in the US (66%), Brazil, South Africa, Mexico, Argentina and the ' 'Philippines were randomized and received study product at time of emerging variants. Median ' 'age 49 years (Q1, Q3: 39, 58), 51% female, 17% Black/African-American and 49% ' 'Hispanic/Latino, with median 6 days from symptom onset. At interim analysis 71% and 97% had a ' 'day 28 and 7 visit, respectively. For all available data at interim review, BRII-196/BRII-198 ' 'compared to placebo had fewer hospitalizations (12 vs. 45) and deaths (1 vs. 9). At day 28 of ' 'follow-up, there was an estimated 78% reduction in hospitalization and/or death (2.4 vs. ' '11.1%), relative risk 0.22 (95% CI: 0.05, 0.86), P=0.00001 (nominal one-sided). Grade 3 or ' 'higher adverse events (AEs) were observed less frequently among BRII-196/BRII-198 ' 'participants than placebo (3.8% vs. 13.4%) with no severe infusion reactions or drug related ' 'serious AEs.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusion</jats:title>\n' ' <jats:p>BRII-196/BRII-198 was safe, well-tolerated, and demonstrated ' 'significant reduction compared to placebo in the risk of hospitalization and/or death among ' 'adults with mild-moderate COVID-19 at high risk for progression to severe disease.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Disclosures</jats:title>\n' ' <jats:p>Kara W. Chew, MD, MS, Amgen (Individual(s) Involved: Self): ' 'Grant/Research Support; Merck Sharp &amp; Dohme (Individual(s) Involved: Self): ' 'Grant/Research Support David Alain Wohl, MD, Gilead Sciences (Individual(s) Involved: Self): ' 'Advisor or Review Panel member, Consultant, Research Grant or Support, Scientific Research ' 'Study Investigator; Janssen (Individual(s) Involved: Self): Advisor or Review Panel member; ' 'Merck (Individual(s) Involved: Self): Advisor or Review Panel member, Research Grant or ' 'Support; ViiV (Individual(s) Involved: Self): Advisor or Review Panel member, Research Grant ' 'or Support Joseph J. Eron, MD, Gilead Sciences (Consultant, Research Grant or Support)Janssen ' '(Consultant, Research Grant or Support)Merck (Consultant)ViiV (Consultant, Research Grant or ' 'Support) David A. Margolis, MD MPH, Brii Biosciences (Employee) Courtney Fletcher, Pharm.D., ' 'National Institute of Allergy and Infectious Diseases, NIH (Grant/Research Support) Davey ' 'Smith, M.D., Linear Therapies, Matrix Biomed, Bayer (Consultant, Shareholder) Eric Daar, ' 'Gilead (Consultant, Grant/Research Support)Merck (Consultant)ViiV (Consultant, Grant/Research ' 'Support)</jats:p>\n' ' </jats:sec>', 'DOI': '10.1093/ofid/ofab466.1643', 'type': 'journal-article', 'created': {'date-parts': [[2021, 12, 5]], 'date-time': '2021-12-05T10:08:51Z', 'timestamp': 1638698931000}, 'page': 'S807-S808', 'source': 'Crossref', 'is-referenced-by-count': 10, 'title': 'LB2. Safety and Efficacy of Combination SARS-CoV-2 Monoclonal Neutralizing Antibodies (mAb) ' 'BRII-196 and BRII-198 in Non-Hospitalized COVID-19 Patients', 'prefix': '10.1093', 'volume': '8', 'author': [ { 'given': 'Teresa H', 'family': 'Evering', 'sequence': 'first', 'affiliation': [{'name': 'Weill Cornell Medicine, New York, NY'}]}, { 'given': 'Mark', 'family': 'Giganti', 'sequence': 'additional', 'affiliation': [ { 'name': 'Harvard T.H. Chan School of Public Health, Boston, ' 'Massachusetts'}]}, { 'given': 'Kara W', 'family': 'Chew', 'sequence': 'additional', 'affiliation': [{'name': 'David Geffen School of Medicine at UCLA'}]}, { 'given': 'Michael', 'family': 'Hughes', 'sequence': 'additional', 'affiliation': [ { 'name': 'Harvard T.H. Chan School of Public Health, Boston, ' 'Massachusetts'}]}, { 'given': 'Carlee', 'family': 'Moser', 'sequence': 'additional', 'affiliation': [ { 'name': 'Harvard T.H. Chan School of Public Health, Boston, ' 'Massachusetts'}]}, { 'given': 'David Alain', 'family': 'Wohl', 'sequence': 'additional', 'affiliation': [{'name': 'UNC School of Medicine, Chapel Hill, NC'}]}, { 'given': 'Judith', 'family': 'Currier', 'sequence': 'additional', 'affiliation': [ { 'name': 'David Geffen School of Medicine at University of California, Los ' 'Angeles, Los Angeles, California'}]}, { 'given': 'Joseph J', 'family': 'Eron', 'sequence': 'additional', 'affiliation': [ { 'name': 'University of North Carolina at Chapel Hill, Chapel Hill, North ' 'Carolina'}]}, { 'given': 'Arzhang', 'family': 'Javan', 'sequence': 'additional', 'affiliation': [{'name': 'National Institute of Health, Bethesda, Maryland'}]}, { 'given': 'David A', 'family': 'Margolis', 'sequence': 'additional', 'affiliation': [{'name': 'Brii Biosciences, Chapel Hill, North Carolina'}]}, { 'given': 'Qing', 'family': 'Zhu', 'sequence': 'additional', 'affiliation': [{'name': 'Brii Biosciences, Chapel Hill, North Carolina'}]}, { 'given': 'Ulises', 'family': 'D’Andrea', 'sequence': 'additional', 'affiliation': [{'name': 'Instituto Medico Rio Cuarto, Rio Cuarto, Cordoba, Argentina'}]}, { 'given': 'Keila', 'family': 'Hoover', 'sequence': 'additional', 'affiliation': [{'name': 'Miami Clinical Research, Miami, Florida'}]}, { 'given': 'Bharat R', 'family': 'Mocherla', 'sequence': 'additional', 'affiliation': [{'name': 'Las Vegas Medical Research, Las Vegas, Nevada'}]}, { 'given': 'Courtney', 'family': 'Fletcher', 'sequence': 'additional', 'affiliation': [{'name': 'University of Nebraska, Omaha, Nebraska'}]}, { 'given': 'Jonathan', 'family': 'Li', 'sequence': 'additional', 'affiliation': [{'name': 'Brigham & Womens Hospital, Boston, Massachusetts'}]}, { 'given': 'Davey', 'family': 'Smith', 'sequence': 'additional', 'affiliation': [{'name': 'University of California, San Diego, San Diego, California'}]}, { 'given': 'Eric', 'family': 'Daar', 'sequence': 'additional', 'affiliation': [{'name': 'Weill Cornell Medicine, New York, NY'}]}], 'member': '286', 'published-online': {'date-parts': [[2021, 12, 4]]}, 'container-title': 'Open Forum Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': '', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': '', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2021, 12, 5]], 'date-time': '2021-12-05T10:26:36Z', 'timestamp': 1638699996000}, 'score': 1, 'resource': {'primary': {'URL': ''}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2021, 11, 1]]}, 'references-count': 0, 'journal-issue': {'issue': 'Supplement_1', 'published-print': {'date-parts': [[2021, 12, 4]]}}, 'URL': '', 'relation': {}, 'ISSN': ['2328-8957'], 'subject': [], 'published-other': {'date-parts': [[2021, 11, 1]]}, 'published': {'date-parts': [[2021, 11, 1]]}}
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