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2 results on '"Hessam Aazami"'

1. REGEN-COV Antibody Cocktail Clinical Outcomes Study in Covid-19 Outpatients

Author

Cynthia Pan, Romana Hosain, Kenneth C. Turner, Gary Herman, Joseph A. Bocchini, Diana Rofail, John D. Davis, Trial Investigators, Adnan Mahmood, Joseph Im, Yuhwen Soo, George D. Yancopoulos, Bari Kowal, Gerard Acloque, Leah Lipsich, Sumathi Sivapalasingam, Yunji Kim, Lilia Roque-Guerrero, Kevin Cannon, Bret J Musser, Mohamed Hussein, Alina Baum, Wendy Kampman, Thomas Norton, Thomas DiCioccio, Amanda Cook, Rafia Bhore, Hessam Aazami, Jennifer D. Hamilton, Andrea T. Hooper, Neil Stahl, David M. Weinreich, Ned Braunstein, Dominique Y Atmodjo, Haitao Gao, Christos A. Kyratsous, Christina Perry, J. Abraham Simon-Campos, Jing Xiao, and Shazia Ali

Subjects
medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), biology, business.industry, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Severe disease, Placebo, Placebo group, Internal medicine, biology.protein, Medicine, Antibody, business, Adverse effect, Viral load
Abstract

BackgroundREGEN-COV antibody cocktail (casirivimab with imdevimab) rapidly reduced viral load and decreased medically-attended visits in the phase 1/2 portion of this trial; REGEN-COV, retains activity in vitro against emerging SARS-CoV-2 variants of concern.MethodsThe phase 3 portion of this adaptive, randomized, master protocol, included 4,057 Covid-19 outpatients with one or more risk factors for severe disease. Patients were randomized to a single treatment of intravenous placebo, or various doses of REGEN-COV, and followed for 28 days. The prespecified hierarchical analysis first compared REGEN-COV 2400mg dose vs concurrent placebo, then compared the 1200mg dose vs concurrent placebo, for endpoints assessing risk of hospitalization or death, and time to symptom resolution. Safety was evaluated in all treated patients.ResultsBoth REGEN-COV 2400mg and 1200mg significantly reduced Covid-19-related hospitalization or all-cause death compared to placebo (71.3% reduction [1.3% vs 4.6%; pConclusionsTreatment with REGEN-COV was well-tolerated and significantly reduced Covid-19-related hospitalization or all-cause death, rapidly resolved symptoms, and reduced viral load.(Funded by Regeneron Pharmaceuticals and the Biomedical and Advanced Research and Development Authority of the Department of Health and Human Services; ClinicalTrials.gov number, NCT04425629.)

Published
2021
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2. REGEN-COV Antibody Combination and Outcomes in Outpatients with Covid-19

Author

David M, Weinreich, Sumathi, Sivapalasingam, Thomas, Norton, Shazia, Ali, Haitao, Gao, Rafia, Bhore, Jing, Xiao, Andrea T, Hooper, Jennifer D, Hamilton, Bret J, Musser, Diana, Rofail, Mohamed, Hussein, Joseph, Im, Dominique Y, Atmodjo, Christina, Perry, Cynthia, Pan, Adnan, Mahmood, Romana, Hosain, John D, Davis, Kenneth C, Turner, Alina, Baum, Christos A, Kyratsous, Yunji, Kim, Amanda, Cook, Wendy, Kampman, Lilia, Roque-Guerrero, Gerard, Acloque, Hessam, Aazami, Kevin, Cannon, J Abraham, Simón-Campos, Joseph A, Bocchini, Bari, Kowal, A Thomas, DiCioccio, Yuhwen, Soo, Gregory P, Geba, Neil, Stahl, Leah, Lipsich, Ned, Braunstein, Gary, Herman, George D, Yancopoulos, and Raji, Ayinla

Subjects
Adult, Male, Relative risk reduction, medicine.medical_specialty, Randomization, Adolescent, Coronavirus disease 2019 (COVID-19), viruses, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Kaplan-Meier Estimate, Antibodies, Monoclonal, Humanized, Placebo, Antiviral Agents, Young Adult, Double-Blind Method, Pregnancy, Internal medicine, Humans, Medicine, Pregnancy Complications, Infectious, Proportional Hazards Models, Dose-Response Relationship, Drug, biology, business.industry, COVID-19, General Medicine, Middle Aged, Viral Load, Antibodies, Neutralizing, COVID-19 Drug Treatment, Hospitalization, Drug Combinations, Relative risk, biology.protein, Female, Original Article, Antibody, business, Viral load
Abstract

Background In the phase 1–2 portion of an adaptive trial, REGEN-COV, a combination of the monoclonal antibodies casirivimab and imdevimab, reduced the viral load and number of medical visits in patients with coronavirus disease 2019 (Covid-19). REGEN-COV has activity in vitro against current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants of concern. Methods In the phase 3 portion of an adaptive trial, we randomly assigned outpatients with Covid-19 and risk factors for severe disease to receive various doses of intravenous REGEN-COV or placebo. Patients were followed through day 29. A prespecified hierarchical analysis was used to assess the end points of hospitalization or death and the time to resolution of symptoms. Safety was also evaluated. Results Covid-19–related hospitalization or death from any cause occurred in 18 of 1355 patients in the REGEN-COV 2400-mg group (1.3%) and in 62 of 1341 patients in the placebo group who underwent randomization concurrently (4.6%) (relative risk reduction [1 minus the relative risk], 71.3%; P

Published
2021
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