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1. Post-acute COVID-19 outcomes including participant-reported long COVID: amubarvimab/romlusevimab versus placebo in the ACTIV-2 trialResearch in context

Author

Teresa H. Evering, Carlee Moser, Nikolaus Jilg, Justin Ritz, David A. Wohl, Jonathan Z. Li, David Margolis, Arzhang Cyrus Javan, Joseph J. Eron, Judith S. Currier, Eric S. Daar, Davey M. Smith, Michael D. Hughes, Kara W. Chew, Kara Chew, David (Davey) Smith, Eric Daar, David Wohl, Judith Currier, Joseph Eron, Michael Hughes, Mark Giganti, Lara Hosey, Jhoanna Roa, Nilam Patel, Kelly Colsh, Irene Rwakazina, Justine Beck, Scott Sieg, Jonathan Li, Courtney Fletcher, William Fischer, Rachel Bender Ignacio, Sandra Cardoso, Katya Corado, Prasanna Jagannathan, Alan Perelson, Sandy Pillay, Cynthia Riviere, Upinder Singh, Babafemi Taiwo, Joan Gottesman, Matthew Newell, Susan Pedersen, Joan Dragavon, Cheryl Jennings, Brian Greenfelder, William Murtaugh, Jan Kosmyna, Morgan Gapara, Akbar Shahkolahi, Verónica Lacal, Diego Salusso, Sebastian Nuñez, Marcelo Rodrigo Rodriguez, Luciana Laborde, Marcelo Papasidero, Luis Wehbe, Mariana Gonzalez, Felicitas Fernandez Voena, Tomas Alvarez, Amaru Lopez, Virginia Huhn, Ulises D'Andrea Nores, Pablo Dieser, Fernando Bordese, Marisa Mussi, Rodrigo de Carvalho Santana, Adriana Aparecida Tiraboschi Bárbaro, Breno Santos, Rita de Cássia Alves Lira, Andre Luiz Machado da Silva, Sandra Wagner Cardoso, Maria Pia Diniz Ribeiro, Nathália Soliva, Eduardo Vasconcellos, Jorge Eurico Ribeiro, Miriam Amaral Enéas, Jorge Pinto, Julia Fonseca de Morais Caporali, Flávia Gomes Faleiro Ferreira, Norma Erendira Rivera Martinez, Victor Casildo Bohorquez Lopez, Melchor Victor Frias, Krystle Fetalvero, Alyxzza Maranan, Jennifer Rosa, Thomas Coetzer, Maureen Mohata, Sr., Umesh Lalloo, Penelope Madlala, Larisha Pillay-Ramaya, Jaclyn Ann Bennet, Noluthando Mwelase, Nokuphiwa Mbhele, Frederick Petrick, Leonard Joubert, Rose Mbali, Sr., Natasha Joseph, Mmatsie Manentsa, Eugene van der Walt, Mduduzi Sandile Lawrance Masilela, Zinhle Zwane, Tendai Chiperera, Lerato Mohapi, Suri Moonsamy, Usha Singh, Kirsten McHarry, Elizma Snyman, Pieter Lennox, James Craig Innes, Oteng Letlape, Olebogeng Jonkane, William Brumskine, Tania Adonis, Ni Ni Sein, Modulakgotla Sebe, Yacoob Vahed, Nazreen Jeewa Hussen, Ismail Mitha, Vasundhara Cheekati, Purna Cheekati, Christie Lummus, Samuel Idarraga, Andrew Kim, David N. Pham, Wei-Hsin Kao, Michael M. Pfeffer, Miriam Batule Dominguez, Anju Malik, Anna Bryan, Melanie Arnold, Idania Fernandez, Cinzia Karpf, Aniuska Ruiz, David Taylor, Eric Folkens, Jennifer Manne, Sigal Yawetz, Cheryl Keenan, Emeka Eziri, Carl Fichtenbaum, Jenifer Baer, Sarah Trentman, Robert Call, Leroy Vaughan, Aaron Milstone, Jamie Alex Slandzicki, Jessica Wallan, Clinton Guillory, Nancy Andrews, Leslie Hughes, Jonathan Berardi, Celine Arar, Randall Quinn, Jorge P. Amaya, Marissa Gomez-Martinez, Luis Cantu, Monica Betancourt-Garcia, Nwora Lance Okeke, Charles M. Burns, Fadi Haddad, Victoria Haddad, Augusto Focil, Griselda Rosas, Susana Moyano, Yaneicy Gonzalez Rojas, Ahmad Aswad, Yevgeniy Bukhman, Manish Jain, Eugene Bukhman, Humam Farah, Rebekah McClain, Sadia Shaik, Timothy Hatlen, Deepa Gotur, Joseph Surber, Jeffrey Kingsley, April Pixler, Alex Zopo, Jack Herman, Craig Herman, Ramon Leon, Boris Nikolov, Fernando Gonzalez Vergara, Ana I. Gonzalez, Noemi Gonzalez, Michael Gelman, Olga Andriunas, Zarema Jagizarov, Jan Westerman, David Davis, Donna Sherer, Kelly Dooley, Becky Becker, Adaliah Wilkins, Jose Pérez, Eloy Roman, Heriberto Fernández, Bharat Mocherla, Kelly Beck, Valarie Maldonado, Jennifer Veltman, Rajesh Gandhi, Katrina Shea, Matthew Planchon, Laura Bogan Herpel, Kaushlendra K. Tripathi, Donald C. Day, John Pullman, Sr., Erin Williams-Leber, Misty Johnson, Michelle Hecker, Ann Avery, Keila Hoover, George W. Monlux, Elizabeth Juneja, Jr., Arthur Wernick, Karelia Ruiz, Maureen Hernández, Yadilys Pérez, Babafemi O. Taiwo, Claudia Hawkins, Baiba Berzins, Carlos Malvestutto, Heather Harber, Robyn Cicarella, Edwin DeJesus, Charlotte-Paige Rolle, Almena L. Free, Sallie D. Pulliam, Debra Weinstein, Rosa M. Suarez, Ezequiel Socorro, Estefania Socorro, Gene Neytman, Raymond Easley, Mariam Aziz, Joan Swiatek, Avish Nagpal, Breanna Kompelien, Kathryn McEvoy, Susan E. Hoover, Allison Lutz, Jessica Just, Manuel Hernandez, Yanly B. Victoria, Gabriel Rodriguez, Divya Pathak, Joshua J. Ordway, Megan Heffner, Patrick Weston, Khalilah Weston, Madhu Choudhary, Jennifer Sullivano, Olayemi Osiyemi, Myriam Izquierdo, Odelsey Torna, Brian Clemency, Renoj Varughese, Joshua Lynch, Aleen Khodabakhshian, Samantha Fortier, Christopher Coyne, Alexandrea Cronin, Constance Benson, Steven Hendrickx, Rosemarie Ramirez, Anne Luetkemeyer, Suzanne Hendler, Dennis Dentoni-Lasofsky, Mobeen Rathore, Saniyyah Mahmoudi, Amna Riaz, Mario Castro, Leslie Spikes, Chase Hall, Jonathan Oakes, Amy James Loftis, Pablo Tebas, William Short, Michael P. Dube, Saahir Khan, Luis M. Mendez, Sarah McGuffin, Chris Jonsson, Mamta K. Jain, Smruthi Senthil, Kimberly Turner-Gray, Sanjay Mehta, Mary Lewinski, Masoud Azizad, Christopher Chow, Lisa Nakatani, Derrick Williamson, Hisham Atriss, Matthew Caloura, Midhun Malla, Hannah Hazard-Jenkins, Aimee Wilkin, Jamraus Fayssoux, Hannah Seagle, Rachel Presti, and Alem Haile

Subjects
COVID-19, Monoclonal antibodies, Outpatient treatment, Clinical trial, Post COVID conditions, Long COVID, Medicine (General), R5-920
Abstract

Summary: Background: It is unknown if early COVID-19 monoclonal antibody (mAb) therapy can reduce risk of Long COVID. The mAbs amubarvimab/romlusevimab were previously demonstrated to reduce risk of hospitalization/death by 79%. This study assessed the impact of amubarvimab/romlusevimab on late outcomes, including Long COVID. Methods: Non-hospitalized high-risk adults within 10 days of COVID-19 symptom onset enrolled in a randomized, double-blind, placebo-controlled phase 2/3 trial of amubarvimab/romlusevimab for COVID-19 treatment. Late symptoms, assessed using a participant-completed symptom diary, were a pre-specified exploratory endpoint. The primary outcome for this analysis was the composite of Long COVID by participant self-report (presence of COVID-19 symptoms as recorded in the diary at week 36) or hospitalization or death by week 36. Inverse probability weighting (IPW) was used to address incomplete outcome ascertainment, giving weighted risk ratios (wRR) comparing amubarvimab/romlusevimab to placebo. Findings: Participants received amubarvimab/romlusevimab (n = 390) or placebo (n = 390) between January and July 2021. Median age was 49 years, 52% were female, 18% Black/African American, 49% Hispanic/Latino, and 9% COVID-19-vaccinated at entry. At week 36, 103 (13%) had incomplete outcome ascertainment, and 66 (17%) on amubarvimab/romlusevimab and 92 (24%) on placebo met the primary outcome (wRR = 0.70, 95% confidence interval (CI) 0.53–0.93). The difference was driven by fewer hospitalizations/deaths with amubarvimab/romlusevimab (4%) than placebo (13%). Among 652 participants with available diary responses, 53 (16%) on amubarvimab/romlusevimab and 44 (14%) on placebo reported presence of Long COVID. Interpretation: Amubarvimab/romlusevimab treatment, while highly effective in preventing hospitalizations/deaths, did not reduce risk of Long COVID. Additional interventions are needed to prevent Long COVID. Funding: National Institute of Allergy and Infectious Diseases of the National Institutes of Health. Amubarvimab and romlusevimab supplied by Brii Biosciences.

Published
2024
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2. Efficacy of N,N‘bis-(2-mercaptoethyl) isophthalamide on mercury intoxication: a randomized controlled trial

Author

Paul Schutzmeier, Augusto Focil Baquerizo, Wilson Castillo-Tandazo, Nicholas Focil, and Stephan Bose-O’Reilly

Subjects
Mercury, Chronic mercury intoxication, Gold mining, NBMI, Chelation therapy, Industrial medicine. Industrial hygiene, RC963-969, Public aspects of medicine, RA1-1270
Abstract

Abstract Background Chronic mercury intoxication is a severe health issue and occurs especially in gold mining communities. Common chelators used for improving mercury elimination are not everywhere available and challenged by poor cell wall penetration. This study is part of a feasibility trial and the aim was to gather first information about the efficacy of the newly developed chelator N,N‘bis-(2-mercaptoethyl) isophthalamide (NBMI) on chronic mercury intoxication. Methods In this three-armed, placebo-controlled randomized trial, 36 miners with mercury urine levels exceeding 15 μg/l were administered 100 mg NBMI, 300 mg NBMI or placebo for 14 days. Levels of mercury in urine [μg/l and μg/g creatinine] and plasma l were analyzed. Therapeutic effect was assessed using the medical intoxication score (MIS) and its single health outcomes (e.g. excessive salivation, sleeping problems), fatigue scores, a neuromotoric test battery (CATSYS) and a neurological outcome (Finger to nose test). Results Physical fatigue was significantly decreased in the 300 mg NBMI group compared to the control. Mercury concentration in urine following 300 mg NBMI treatment was significantly lowered compared to control, however, this effect was less distinct with adjustment for creatinine. Conclusion NBMI showed an effect on physical fatigue and there were indications to positive effects on other symptoms as well. More comprehensive studies are mandatory to verify the effects of NBMI as a novel tool for treating mercury intoxications. Trial registration ClinicalTrials.gov Identifier: NCT02486289. Date of registration: June 24, 2015.

Published
2018
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3. Comparison of FRAX Scores of Southern California Females of Mexican Descent Using US Hispanic and Mexico Database

Author

Keaton M. Nasser, Augusto Focil, and Stuart L. Silverman

Subjects
Medicine
Abstract

Introduction. Regional differences for fracture risk of US Hispanics may vary by national origin. In California, where a majority of the Hispanic population is of Mexican descent, it is of interest to compare the FRAX absolute risk using the US Hispanic and Mexico databases. Methods. We collected FRAX risk factor data from 134 women of Mexican descent in southern California. The FRAX risk score was calculated using the US Hispanic and Mexican databases, using the NOF guidelines for osteoporosis to compare the number of patients that would be selected for treatment. Results. The 10-year absolute risk of major osteoporotic fracture among women of Mexican descent using the US Hispanic database was 4.82 ± 5.03 (95% CI 3.97–5.67) compared to 4.86 ± 4.72 (CI 3.98–5.44) using the Mexico database (P=.94). The 10-year risk for hip fracture was 0.86 ± 1.78 (CI .56–1.16) compared to 1.12 ± 1.97 (CI .79–1.45, P=.26). The mean conformity for meeting the interventional threshold by either risk score was 94.8%. Conclusion. The comparison between the FRAX databases demonstrates a similarity in the absolute risk of major osteoporotic fracture. Differences are noted in the absolute number of hip fracture subjects at risk, but there is a high rate of conformity.

Published
2011
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4. Author response for 'Maintenance of Glycemic Control with Liraglutide versus Oral Antidiabetic Drugs as Add‐on Therapies in Patients with Type 2 Diabetes Uncontrolled with Metformin Alone: A Randomized Clinical Trial in Primary Care ( LIRA‐PRIME )'

Author

null Jeff Unger, null Dale C. Allison, null Margit Kaltoft, null Kavitha Lakkole, null Jayant K. Panda, null Chethana Ramesh, null Mehmet Sargin, null Elena Smolyarchuk, null Melissa Twine, null Benjamin Wolthers, null Gizem Yarimbas, null Marouan Zoghbi, null Dennis O'Keefe, null Murdo Ferguson, null Anil Gupta, null Ronald Akhras, null Sean Peterson, null Guy Chouinard, null Sameh Fikry, null Richard Tytus, null David Crowley, null Pierre Filteau, null Sandra Barrera Silva, null Alexander Gonzalez, null Luis Gomez‐Botero, null Ghanshyam Pangtey, null S. Prabhu, null Pooja Khosla, null Arun Narayan, null Anil Awasthi, null Rohan Sequeria, null Reema Kashiva, null K. N. Manohar, null Ashwini Joshi, null Ajay Agarwal, null S. S. Ramesh, null Sanjay Agarwal, null Dipti Chand, null Dinesh Jain, null Ram Kaulgud, null Arija Lace, null Georges Bou Haidar, null Marwan Zoghbi, null Rania Sakr, null Grace Abi Rizk, null Tatiana Stepanova, null Albina Golovach, null Ruslan Sardinov, null Sergey Martsevich, null Branka Djuric‐Pejovic, null Svetlana Manojlovic‐Kulovic, null Jelena Bajic, null Danica Bacanin‐Jovanovic, null Snezana Stojilkovic, null Ivan Kostic, null Burcu Dogan, null Mehmet Burak Aktuglu, null Ozlem Cigerli, null Marshall Anderson, null William Byars, null David Butuk, null Kenneth Cohen, null Alexander Dela Llana, null Ankur Doshi, null Bryan Feldman, null Neil Fraser, null Michael Lillestol, null Robert Hippert, null Sashi Makam, null Stuart Stoller, null Lawrence Allen, null Richard Beasley, null Ramin Farsad, null Horacio Hidalgo, null Michael Soboeiro, null Kenneth Blaze, null William Simon, null Eric Dedeke, null Brian Everhart, null Michelle Look, null James Kahrs, null Melissa Poindexter, null Stephen Falkowski, null Clancy Cone, null Charles Crump, null Richard Jackson, null Augusto Focil, null Terence Hart, null Brent Hella, null Susan Kemp, null Cesar Albarracin, null Martin Schear, null Dwayne Williams, null Dwayne O. Williams, null John Willis, null Thomas Wolf, null Jennifer Bellucci‐Jackson, null Jonathan Condit, null Munib Daudjee, null Robert Detweiler, null Michael DiGiovanna, null Neil Farris, null Matthew Finneran, null Frank Fusco, null Peter Gagianas, null Sidney Gorton, null Marvin Heuer, null Jose Alvarez, null Gary Korff, null Joseph Lomboy, null Richard Lorraine, null Charles Lovell, null Caroline Mbogua, null Deirdre McMullen, null Richard Murphy, null Henry Naddaf, null Thomas O'Connor, null Stephen Ong, null Bryce Palchick, null David Pham, null Marina Raikhel, null Mercedes Samson, null Horia Tatu, null Henry Traylor, null Jeffrey Unger, null Dave Webster, null Kathleen Harris, null Steven Bauer, null Gary Bedel, null Mark Benson, null Isaac Beshay, null Rafael Canadas, null Cathy Hurley, null Thomas Davis, null H. Jackson Downey, null Gregory Haase, null Lee Herman, null Moises Issa, null Randal Jacks, null Curtis Jantzi, null David Johnson, null Ted Kubicki, null Reginald Parker, null Raman Purighalla, null Thaddeus Riley, null Gildardo Ceballos, null Robert Schreiman, null Robert Scott, null Matthew Lewis, null Amit Shah, null Charles Sharpe, null Kanagaratnam Sivalingam, null Stephen Smith, null Joseph Woolley, null Dilawar Ajani, null Eric Ball, null Daniel Schlosser, null Elmer Stout, null Moshir Jacob, null Bradley Block, null Wilfred McKenzie, null Carl Meisner, null Timothy Kitchen, null Daniel Koontz, null Joseph Labuda, null Howard Wenocur, null Robert Broker, null Zeeshan Shaikh, null Marcy Goisse, null David Headley, null David M. Headley, null Elba Perez‐Vargas, null Christopher Chow, null Alex Guevara, null Ralph Wade, null John Sibille, null Ajit Shah, null Kenneth Fox, null Vonda Houchin, null John Sensenbrenner, null Boyde Harrison, null Otis Barnum, null Bruce Weber, null Joseph Risser, null Steven Barag, null Anita Mercado, null Royce Solano, null Steve Simpson, null Kari Uusinarkaus, null Jose Burbano, null Richard Glover, null Ciro Reyes, null Julian Gonzalez, null C. Sofley, null Timothy Dao, null Michael Winnie, null Howard Ellison, null Tarek Hassanein, null Govinda Lohani, null Jon McRae, null Fadi Saba, null James Shoemaker, null Kelly Taylor, null Miguel Trevino, null Hernan Salazar, null Irene Sobolevsky, null Daniel Pomposini, null Garth Vaz, null Mark Fredrick, null Larry Berman, null Gregory Allen, null Maja Delibasic, null Carl Griffin, null Bram Wieskopf, null Aron Schlau, null Wayne Reynolds, null S. Michael Sutton, null Allen Geltzer, null Matthew Hummel, null Thomas Fiel, null Scott Kaiser, null David Francyk, null Kevin Pounds, null William Kirby, null Peter Levins, null Gregston Nelson, and null LIRA‐PRIME investigators

Published
2021
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5. Efficacy of N,N'bis-(2-mercaptoethyl) isophthalamide on mercury intoxication: a randomized controlled trial

Author

Wilson Castillo-Tandazo, Stephan Bose-O'Reilly, Augusto Focil Baquerizo, Nicholas Focil, and Paul Schutzmeier

Subjects
Male, Health, Toxicology and Mutagenesis, Urine, 010501 environmental sciences, 01 natural sciences, Gastroenterology, law.invention, chemistry.chemical_compound, 0302 clinical medicine, Randomized controlled trial, law, Chelating Agents, lcsh:Public aspects of medicine, Hispanic or Latino, Middle Aged, 3. Good health, NBMI, Physical Fatigue, lcsh:Industrial medicine. Industrial hygiene, Environmental Pollutants, Adult, medicine.medical_specialty, Cysteamine, Chelation therapy, Phthalic Acids, chemistry.chemical_element, Placebo, Mining, lcsh:RC963-969, 03 medical and health sciences, Young Adult, Gold mining, Internal medicine, Occupational Exposure, medicine, Humans, Chronic mercury intoxication, 0105 earth and related environmental sciences, Creatinine, Dose-Response Relationship, Drug, business.industry, Research, Therapeutic effect, Public Health, Environmental and Occupational Health, lcsh:RA1-1270, Mercury, Mercury (element), chemistry, Mercury Poisoning, Gold, business, 030217 neurology & neurosurgery
Abstract

BACKGROUND: Chronic mercury intoxication is a severe health issue and occurs especially in gold mining communities. Common chelators used for improving mercury elimination are not everywhere available and challenged by poor cell wall penetration. This study is part of a feasibility trial and the aim was to gather first information about the efficacy of the newly developed chelator N,N'bis-(2-mercaptoethyl) isophthalamide (NBMI) on chronic mercury intoxication. METHODS: In this three-armed, placebo-controlled randomized trial, 36 miners with mercury urine levels exceeding 15μg/l were administered 100mg NBMI, 300mg NBMI or placebo for 14days. Levels of mercury in urine [μg/l and μg/g creatinine] and plasma l were analyzed. Therapeutic effect was assessed using the medical intoxication score (MIS) and its single health outcomes (e.g. excessive salivation, sleeping problems), fatigue scores, a neuromotoric test battery (CATSYS) and a neurological outcome (Finger to nose test). RESULTS: Physical fatigue was significantly decreased in the 300mg NBMI group compared to the control. Mercury concentration in urine following 300mg NBMI treatment was significantly lowered compared to control, however, this effect was less distinct with adjustment for creatinine. CONCLUSION: NBMI showed an effect on physical fatigue and there were indications to positive effects on other symptoms as well. More comprehensive studies are mandatory to verify the effects of NBMI as a novel tool for treating mercury intoxications. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02486289 . Date of registration: June 24, 2015.

Published
2018

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